CompletedNCT01468701Updated Mar 29, 2021Results posted

GLORIA-AF Registry Program - Second and Third Phases

An observational study in Stroke and Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 666 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-29.

Sponsored by Boehringer Ingelheim · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 37,235
Ages: 18 Years and older
Sex: All

Study summary

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

Conditions studied

Stroke
Atrial Fibrillation

Browse trials for

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 37,235 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

patients with non-valvular AF

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age =>18 years at enrollment
Male or female patient (or legally acceptable representative) willing and able to provide written
Patient newly diagnosed (\< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.

Other inclusion criteria apply.

Exclusion criteria

Exclusion criteria:

Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
AF with a generally reversible cause;
Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 37,235 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke or Systemic Embolism - Phase III
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke - Phase II
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Stroke - Phase III
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Systemic Embolism (SE) - Phase II
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Systemic Embolism (SE) - Phase III
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase II
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase III
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase II
Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase III
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Life-threatening Bleeding Events - Phase II
Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Life-threatening Bleeding Events - Phase III
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Myocardial Infarction (MI) - Phase II
Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Myocardial Infarction (MI) - Phase III
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of All-cause Death - Phase II
Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of All-cause Death - Phase III
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Death - Phase II
Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
Time frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Death - Phase III
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
Time frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Results

Posted Mar 29, 2021

Limitations and caveats

Phase II part of 1160.129 includes Phase II data from 1160.129, 1160.136 and 1160.171.

Participant flow

GLORIA-AF was an international, multicentre, non-interventional study based on prospectively collected data for patients (pts) with newly diagnosed non-valvular atrial fibrillation (NVAF). In Ph II, pts baseline characteristics (BC), their antithrombotic treatment patterns and outcomes with 2 years of follow-up for dabigatran alone were collected prospectively. Ph III collected prospective data on pts BC, their treatments and outcomes with 3 years of follow-up for all pts in real-world setting.

Participant flow — Overall Study
Milestone	Dabigatran Etexilate - Baseline (Phase II)	Vitamin K Antagonist (VKA) - Baseline (Phase II)	Rivaroxaban - Baseline (Phase II)	Apixaban - Baseline (Phase II)	Acetylsalicylic Acid (ASA) - Baseline (Phase II)	Antiplts Other Than ASA - Baseline (Phase II)	No Treatment - Baseline (Phase II)	Combinations With Oral Anticoagulants - Baseline (Phase II)	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)	Rivaroxaban - Baseline (Phase III)	Apixaban - Baseline (Phase III)	Edoxaban - Baseline (Phase III)	Acetylsalicylic Acid (ASA) - Baseline (Phase III)	Antiplts Other Than ASA - Baseline (Phase III)	No Treatment - Baseline (Phase III)	Combinations With Oral Anticoagulants - Baseline (Phase III)
Started	4964	5103	1784	715	1736	128	1209	5	3879	4962	4054	4538	333	2182	214	1418	11
All eligible patient	4873	4963	1755	703	1714	126	1170	4	3839	4836	4015	4505	332	2163	213	1386	11
Completed	3965	0	0	0	0	0	0	0	3219	3780	3256	3672	284	1712	151	1056	10
Not completed	999	5103	1784	715	1736	128	1209	5	660	1182	798	866	49	470	63	362	1
Withdrew: Not eligible	91	140	29	12	22	2	39	1	40	126	39	33	1	19	1	32	0
Withdrew: Lost to follow-up	306	0	0	0	0	0	0	0	215	309	224	212	11	164	17	127	1
Withdrew: Withdrawal by subject	165	0	0	0	0	0	0	0	83	88	100	114	9	47	6	31	0
Withdrew: Other reasons than listed	437	0	0	0	0	0	0	0	318	658	433	504	28	239	39	172	0
Withdrew: No end of study case report form	0	0	0	0	0	0	0	0	4	1	2	3	0	1	0	0	0
Withdrew: Not being followed up	0	4963	1755	703	1714	126	1170	4	0	0	0	0	0	0	0	0	0

Outcome measures

PrimaryIncidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II

Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II	2.06 (1.74 to 2.42)

PrimaryIncidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III

Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III	2.21 (1.88 to 2.57)	3.23 (2.83 to 3.62)

Statistical analysis

Dabigatran Etexilate - Baseline (Phase III) vs Vitamin K Antagonist (VKA) - Baseline (Phase III) · Regression, Cox · Hazard ratio (hr): 0.74 · 95% CI 0.60 to 0.90Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

PrimaryIncidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II

Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II	1.74 (1.45 to 2.07)

PrimaryIncidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III

Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III	1.91 (1.59 to 2.24)	2.62 (2.27 to 2.96)

Statistical analysis

Dabigatran Etexilate - Baseline (Phase III) vs Vitamin K Antagonist (VKA) - Baseline (Phase III) · Regression, Cox · Hazard ratio (hr): 0.79 · 95% CI 0.63 to 0.98Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

PrimaryIncidence Rate of Stroke or Systemic Embolism - Phase III

Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Stroke or Systemic Embolism - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Stroke or Systemic Embolism - Phase III	0.80 (0.61 to 1.01)	1.00 (0.80 to 1.22)

Statistical analysis

Dabigatran Etexilate - Baseline (Phase III) vs Vitamin K Antagonist (VKA) - Baseline (Phase III) · Regression, Cox · Hazard ratio (hr): 0.79 · 95% CI 0.57 to 1.11Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

PrimaryIncidence Rate of Stroke - Phase II

Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Stroke - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Stroke - Phase II	0.65 (0.48 to 0.87)

PrimaryIncidence Rate of Stroke - Phase III

Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Stroke - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Stroke - Phase III	0.77 (0.58 to 0.97)	0.96 (0.76 to 1.17)

Statistical analysis

Dabigatran Etexilate - Baseline (Phase III) vs Vitamin K Antagonist (VKA) - Baseline (Phase III) · Regression, Cox · Hazard ratio (hr): 0.81 · 95% CI 0.57 to 1.14Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

PrimaryIncidence Rate of Transient Ischaemic Attack (TIA) - Phase II

Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II	0.21 (0.12 to 0.34)

PrimaryIncidence Rate of Transient Ischaemic Attack (TIA) - Phase III

Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III	0.29 (0.17 to 0.42)	0.32 (0.21 to 0.45)

PrimaryIncidence Rate of Systemic Embolism (SE) - Phase II

Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Systemic Embolism (SE) - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Systemic Embolism (SE) - Phase II	0.04 (0.01 to 0.12)

PrimaryIncidence Rate of Systemic Embolism (SE) - Phase III

Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Systemic Embolism (SE) - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Systemic Embolism (SE) - Phase III	0.04 (0.00 to 0.09)	0.05 (0.01 to 0.09)

PrimaryIncidence Rate of Pulmonary Embolism (PE) - Phase II

Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Pulmonary Embolism (PE) - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Pulmonary Embolism (PE) - Phase II	0.07 (0.02 to 0.16)

PrimaryIncidence Rate of Pulmonary Embolism (PE) - Phase III

Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Pulmonary Embolism (PE) - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Pulmonary Embolism (PE) - Phase III	0.07 (0.01 to 0.13)	0.06 (0.01 to 0.11)

PrimaryIncidence Rate of Major Bleeding Events (MBE) - Phase II

Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Major Bleeding Events (MBE) - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Major Bleeding Events (MBE) - Phase II	0.97 (0.76 to 1.23)

PrimaryIncidence Rate of Major Bleeding Events (MBE) - Phase III

Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Major Bleeding Events (MBE) - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Major Bleeding Events (MBE) - Phase III	0.69 (0.51 to 0.89)	1.44 (1.20 to 1.70)

Statistical analysis

Dabigatran Etexilate - Baseline (Phase III) vs Vitamin K Antagonist (VKA) - Baseline (Phase III) · Regression, Cox · Hazard ratio (hr): 0.52 · 95% CI 0.38 to 0.73Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

PrimaryIncidence Rate of Life-threatening Bleeding Events - Phase II

Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Life-threatening Bleeding Events - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Life-threatening Bleeding Events - Phase II	0.46 (0.32 to 0.64)

PrimaryIncidence Rate of Life-threatening Bleeding Events - Phase III

Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Life-threatening Bleeding Events - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Life-threatening Bleeding Events - Phase III	0.47 (0.32 to 0.63)	1.07 (0.86 to 1.30)

PrimaryIncidence Rate of Myocardial Infarction (MI) - Phase II

Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Myocardial Infarction (MI) - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Myocardial Infarction (MI) - Phase II	0.50 (0.35 to 0.69)

PrimaryIncidence Rate of Myocardial Infarction (MI) - Phase III

Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Myocardial Infarction (MI) - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Myocardial Infarction (MI) - Phase III	0.40 (0.27 to 0.55)	0.53 (0.38 to 0.68)

Statistical analysis

Dabigatran Etexilate - Baseline (Phase III) vs Vitamin K Antagonist (VKA) - Baseline (Phase III) · Regression, Cox · Hazard ratio (hr): 0.97 · 95% CI 0.60 to 1.57Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

PrimaryIncidence Rate of All-cause Death - Phase II

Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of All-cause Death - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of All-cause Death - Phase II	2.48 (2.13 to 2.87)

PrimaryIncidence Rate of All-cause Death - Phase III

Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of All-cause Death - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of All-cause Death - Phase III	2.16 (1.84 to 2.48)	3.57 (3.19 to 3.96)

Statistical analysis

Dabigatran Etexilate - Baseline (Phase III) vs Vitamin K Antagonist (VKA) - Baseline (Phase III) · Regression, Cox · Hazard ratio (hr): 0.66 · 95% CI 0.54 to 0.80Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).

PrimaryIncidence Rate of Vascular Death - Phase II

Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.

Time frame:: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Vascular Death - Phase II
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase II)
Incidence Rate of Vascular Death - Phase II	0.85 (0.65 to 1.09)

PrimaryIncidence Rate of Vascular Death - Phase III

Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.

Time frame:: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Reported as:: Number · Events per 100 person-years

Incidence Rate of Vascular Death - Phase III
Events per 100 person-years	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)
Incidence Rate of Vascular Death - Phase III	0.75 (0.56 to 0.95)	1.26 (1.03 to 1.50)

Adverse events

Collected over Phase (Ph) II: From baseline visit of Phase II until Phase II completion or discontinuation, up to 2 years of follow-up. Only patients who were prescribed Dabigatran etexilate at baseline of Phase II were followed up. Phase III: From baseline visit of Phase III until study completion or discontinuation, up to 3 years of follow-up for all patients irrespective of their antithrombotic treament.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dabigatran Etexilate - Baseline (Phase II)	184/4,943 (3.7%)	985/4,943 (19.9%)	0/4,943 (0%)
Dabigatran Etexilate - at Least Once During Phase III of the Study	199/4,477 (4.4%)	118/4,477 (2.6%)	0/4,477 (0%)
Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study	465/5,894 (7.9%)	296/5,894 (5%)	0/5,894 (0%)
Rivaroxaban - at Least Once During Phase III of the Study	292/5,177 (5.6%)	185/5,177 (3.6%)	0/5,177 (0%)
Apixaban - at Least Once During Phase III of the Study	392/6,024 (6.5%)	217/6,024 (3.6%)	0/6,024 (0%)
Edoxaban - at Least Once During Phase III of the Study	23/686 (3.4%)	16/686 (2.3%)	0/686 (0%)
Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study	469/6,263 (7.5%)	225/6,263 (3.6%)	0/6,263 (0%)
Antiplts Other Than ASA - at Least Once During Phase III of the Study	46/780 (5.9%)	19/780 (2.4%)	0/780 (0%)

Most frequent serious events

Showing 10 of 592

Most frequent serious events
Event	Dabigatran Etexilate - Baseline (Phase II)	Dabigatran Etexilate - at Least Once During Phase III of the Study	Vitamin K Antagonist (VKA) - at Least Once During Phase III of the Study	Rivaroxaban - at Least Once During Phase III of the Study	Apixaban - at Least Once During Phase III of the Study	Edoxaban - at Least Once During Phase III of the Study	Acetylsalicylic Acid (ASA) - at Least Once During Phase III of the Study	Antiplts Other Than ASA - at Least Once During Phase III of the Study
Atrial fibrillationCardiac disorders	159/4943	0/4477	3/5894	2/5177	1/6024	0/636	3/6263	0/780
Cardiac failureCardiac disorders	67/4943	3/4477	4/5894	0/5177	2/6024	0/636	1/6263	0/780
DeathGeneral disorders	48/4943	0/4477	0/5894	0/5177	0/6024	0/636	0/6263	0/780
Cardiac failure congestiveCardiac disorders	41/4943	1/4477	1/5894	0/5177	0/6024	0/636	0/6263	0/780
PneumoniaInfections and infestations	41/4943	1/4477	0/5894	2/5177	2/6024	0/636	0/6263	0/780
Gastrointestinal haemorrhageGastrointestinal disorders	24/4943	16/4477	27/5894	36/5177	26/6024	3/636	43/6263	4/780
Myocardial infarctionCardiac disorders	27/4943	2/4477	2/5894	1/5177	0/6024	0/636	2/6263	0/780
Upper gastrointestinal haemorrhageGastrointestinal disorders	6/4943	8/4477	18/5894	8/5177	12/6024	0/636	9/6263	4/780
DyspnoeaRespiratory, thoracic and mediastinal disorders	23/4943	1/4477	0/5894	0/5177	4/6024	0/636	1/6263	0/780
Lower gastrointestinal haemorrhageGastrointestinal disorders	5/4943	12/4477	11/5894	21/5177	10/6024	1/636	20/6263	3/780

Baseline characteristics

All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).

Age, Continuous
Age, Continuous(Years)	Dabigatran Etexilate - Baseline (Phase II)	Vitamin K Antagonist (VKA) - Baseline (Phase II)	Rivaroxaban - Baseline (Phase II)	Apixaban - Baseline (Phase II)	Acetylsalicylic Acid (ASA) - Baseline (Phase II)	Antiplts Other Than ASA - Baseline (Phase II)	No Treatment - Baseline (Phase II)	Combinations With Oral Anticoagulants - Baseline (Phase II)	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)	Rivaroxaban - Baseline (Phase III)	Apixaban - Baseline (Phase III)	Edoxaban - Baseline (Phase III)	Acetylsalicylic Acid (ASA) - Baseline (Phase III)	Antiplts Other Than ASA - Baseline (Phase III)	No Treatment - Baseline (Phase III)	Combinations With Oral Anticoagulants - Baseline (Phase III)	Total
Mean	70.2 ± 10.4	71.4 ± 10.6	71.5 ± 10.6	73.8 ± 10.0	67.7 ± 12.4	73.5 ± 10.7	68.3 ± 12.5	76.0 ± 8.3	70.1 ± 10.2	71.2 ± 10.3	70.3 ± 10.2	72.4 ± 10.1	72.3 ± 9.4	68.0 ± 11.8	73.1 ± 10.8	67.6 ± 12.2	70.2 ± 12.1	70.5 ± 10.8

Sex: Female, Male
Sex: Female, Male(Participants)	Dabigatran Etexilate - Baseline (Phase II)	Vitamin K Antagonist (VKA) - Baseline (Phase II)	Rivaroxaban - Baseline (Phase II)	Apixaban - Baseline (Phase II)	Acetylsalicylic Acid (ASA) - Baseline (Phase II)	Antiplts Other Than ASA - Baseline (Phase II)	No Treatment - Baseline (Phase II)	Combinations With Oral Anticoagulants - Baseline (Phase II)	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)	Rivaroxaban - Baseline (Phase III)	Apixaban - Baseline (Phase III)	Edoxaban - Baseline (Phase III)	Acetylsalicylic Acid (ASA) - Baseline (Phase III)	Antiplts Other Than ASA - Baseline (Phase III)	No Treatment - Baseline (Phase III)	Combinations With Oral Anticoagulants - Baseline (Phase III)	Total
Female	2162	2304	773	338	778	58	553	2	1718	2152	1766	2104	139	931	92	660	6	16536
Male	2711	2659	982	365	936	68	617	2	2121	2684	2249	2401	193	1232	121	726	5	20072

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Dabigatran Etexilate - Baseline (Phase II)	Vitamin K Antagonist (VKA) - Baseline (Phase II)	Rivaroxaban - Baseline (Phase II)	Apixaban - Baseline (Phase II)	Acetylsalicylic Acid (ASA) - Baseline (Phase II)	Antiplts Other Than ASA - Baseline (Phase II)	No Treatment - Baseline (Phase II)	Combinations With Oral Anticoagulants - Baseline (Phase II)	Dabigatran Etexilate - Baseline (Phase III)	Vitamin K Antagonist (VKA) - Baseline (Phase III)	Rivaroxaban - Baseline (Phase III)	Apixaban - Baseline (Phase III)	Edoxaban - Baseline (Phase III)	Acetylsalicylic Acid (ASA) - Baseline (Phase III)	Antiplts Other Than ASA - Baseline (Phase III)	No Treatment - Baseline (Phase III)	Combinations With Oral Anticoagulants - Baseline (Phase III)	Total
American Indian or Alaska Native	20	14	6	0	4	0	1	0	27	32	32	21	0	7	2	3	1	170
Asian	423	797	111	93	694	43	603	0	841	760	381	413	125	916	95	593	8	6896
Black/African American	40	86	42	14	44	0	23	0	47	85	72	118	2	49	2	23	0	647
Native Hawaiian/Other Pacific Islander	0	3	1	0	1	0	1	0	0	0	0	1	0	2	0	0	0	9
White	3372	3590	1375	538	863	70	497	4	2484	3611	3126	3528	203	1057	104	708	2	25132
Other	447	262	69	24	82	10	21	0	181	144	144	79	2	57	7	32	0	1561
Missing	571	211	151	34	26	3	24	0	259	204	260	345	0	75	3	27	0	2193

Study locations

666 sites

University South Alabama Medical Center
Mobile, Alabama 38817, United States
Black Warrior Research
Northport, Alabama 35476, United States
Scottsboro Quick Care Clinic
Scottsboro, Alabama 35768, United States
Alaska Heart Institute
Anchorage, Alaska 99508, United States
Phoenix Heart PLLC
Glendale, Arizona 85306, United States
Mercy Cinic Hot Springs Communities
Hot Springs, Arizona 71913, United States
Midwest Internal Medicine, PLLC
Lake Havasu City, Arizona 86403, United States
Sparks Regional Medical Center
Fort Smith, Arkansas 72901, United States
Dr. Michael A. Frais, Cardiologist, P.A.
Hot Springs, Arkansas 71913, United States
Cardiology and Medicine Clinic
Little Rock, Arkansas 72204, United States
Donald W. Reynolds Institute on Aging
Little Rock, Arkansas 72205-7199, United States
Arkansas Cardiology, PA
Little Rock, Arkansas 72205, United States
Diagnamics, Inc
Encinitas, California 92024, United States
Allianz Medical and Research Center
Fountain Valley, California 92708, United States
B&K Medical Research Center
Fresno, California 93721, United States
American Clinical Trials
Hawaiian Gardens, California 90716, United States
Scripps Clinic
La Jolla, California 92037, United States
La Mesa Cardiac Center
La Mesa, California 91942, United States
Los Alamitos Cardiovascular
Los Alamitos, California 90720, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California 90073, United States
Mehrdad Kevin Ariani, MD, Incorporated
Northridge, California 91325, United States
VA Palo Alto Health Care System
Palo Alto, California 94304, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California 92270, United States
Ritchken and First MD's
San Diego, California 92117, United States
Coastal Heart Group Inc
Santa Ana, California 92704, United States
Pacific Heart and Vascular
Stockton, California 95210, United States
Southwest Heart Institute
Temecula, California 92591, United States
University of California Los Angeles
Torrance, California 90509, United States
Cardiology Associates Medical Group Inc
Ventura, California 93003, United States
Ventura Cardiology Consultants Medical Group, Inc
Ventura, California 93003, United States
Ventura Clinical Trials
Ventura, California 93003, United States
Office of Dr. David J Cislowski MD
Visalia, California 93291, United States
Aurora Denver Cardiology Associates, PC
Aurora, Colorado 80012, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado 80909, United States
Pikes Peak Cardiology
Colorado Springs, Colorado 80909, United States
Denver Health Medical Center
Denver, Colorado 80204, United States
South Denver Cardiology Associates, PC
Littleton, Colorado 80120, United States
Connecticut Clinical Research, LLC
Bridgeport, Connecticut 06606, United States
Connecticut Heart and Vascular Center
Bridgeport, Connecticut 06606, United States
Bridgeport Hospital
Bridgeport, Connecticut 06610, United States
Cardiology Associates of Fairfield County
Norwalk, Connecticut 06851, United States
Norwalk Medical Group
Norwalk, Connecticut 06851, United States
Heart Specialists, PC of Southern CT
Shelton, Connecticut 06484, United States
Red Clay Research LLC.
Newark, Delaware 19713, United States
Howard University Hospital
Washington, District of Columbia 20006, United States
Cardiac Arrhythmia Center
Washington, District of Columbia 20010, United States
Medical Faculty Associates, Inc
Washington, District of Columbia 20037, United States
Aventura Institute for Cardiovascular Wellness, PA
Aventura, Florida 33180, United States
Bay Area Cardiology
Brandon, Florida 33511, United States
Tampa Bay Medical Research
Clearwater, Florida 33761, United States
Seidman Clinical Trials
Delray Beach, Florida 33484, United States
Universal Clinical Research Associates
Doral, Florida 33166, United States
Cardiovascular Research of North Florida LLC
Gainesville, Florida 32605, United States
Magi Research Clinic, Inc
Hialeah, Florida 33013, United States
Global Research Solutions Corporation
Hollywood, Florida 33021, United States
St. Vincent's Ambulatory Care
Jacksonville, Florida 32216, United States
Tenet Florida Physician Services
Jupiter, Florida 33458, United States
Watson Clinic Center for Research, Inc
Lakeland, Florida 33805, United States
A&L Clinical Research
Miami, Florida 33126, United States
Miami Center for Cardiovascular Disease
Miami, Florida 33136, United States
Global Research Solutions Corporation
Miami, Florida 33144, United States
Cardiovascular Research Center of South Florida
Miami, Florida 33173, United States
New Horizon Research Center
Miami, Florida 33175, United States
Sacred Heart Medical Specialty Group
Miramar Beach, Florida 32550, United States
Collier HMA Physician Management
Naples, Florida 34119, United States
Edgewater Medical Research
New Smyrna Beach, Florida 32169, United States
SouthEast Medical Centre
Oakland Park, Florida 33309, United States
Research One
Orlando, Florida 32806, United States
South Florida Research Solutions, LLC
Pembroke Pines, Florida 33028, United States
Langhorne Cardiology Consultants, Inc
Pensacola, Florida 32501, United States
VNH Heart Center Research
Port Charlotte, Florida 33952, United States
Brevard Cardiovascular Research Associates, Inc
Rockledge, Florida 32955, United States
Suncoast Cardiovascular Research Inc.
Saint Petersburg, Florida 33701, United States
Northside Hospital
Saint Petersburg, Florida 33709, United States
Alternative Solutions Medical Research and Prevention Center
Saint Petersburg, Florida 33711, United States
Velella Research, Inc
Sarasota, Florida 34233, United States
Cardiovascular Center of Sarasota
Sarasota, Florida 34239, United States
James C. Neiman, MD
Seminole, Florida 33772, United States
Tallahassee Research Instutite
Tallahassee, Florida 32308, United States
University of South Florida
Tampa, Florida 33606, United States
Indian River Medical Associates Cardiology
Vero Beach, Florida 32960, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida 33449, United States
Executive Health and Research Associates
Atlanta, Georgia 30342, United States
Saint Joseph's Research Institute
Atlanta, Georgia 30342, United States
Atlanta Heart Specialists, LLC
Cumming, Georgia 30041, United States
William C McGarity, Jr, MD, PC
Decatur, Georgia 30035, United States
Coliseum Medical Center
Macon, Georgia 31217, United States
Kootenai Heart Clinics, LLC
Coeur d'Alene, Idaho 83814, United States
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois 60005, United States
Prairie Cardiovascular Memorial Hospital
Carbondale, Illinois 62901, United States
Captain James A. Lovell Federal Health Care Center
Chicago, Illinois 60064, United States
Medex Healthcare Research
Chicago, Illinois 60602, United States
John H. Stroger Jr. Hospital of Cook Country
Chicago, Illinois 60612, United States
University of Illinois at Chicago
Chicago, Illinois 60612, United States
North Shore Cardiology Consultants
Chicago, Illinois 60631, United States
University of Chicago
Chicago, Illinois 60637, United States
Northwestern University
Evanston, Illinois 60208, United States
Advanced Heart Care, LLC, Medicoricum, LLC
Fairview Heights, Illinois 62208, United States
Adventist Health Partners, Inc
Hinsdale, Illinois 60521, United States
Consultants in Cardiovascular Medicine
Melrose Park, Illinois 60160, United States

Showing the first 100 of 666 sites across 21 countries. Choose a country and city above to see the rest.

References and documents

Publications

Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25. PubMed 35876418 ↗
Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29. PubMed 35488127 ↗
Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Marler S, Gurusamy VK, Huisman MV; GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry. Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16. Erratum In: Clin Res Cardiol. 2022 May;111(5):593. doi: 10.1007/s00392-022-02021-2. PubMed 35294625 ↗
Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16. PubMed 35294623 ↗
Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4. PubMed 35243870 ↗
Lopez-Sendon JL, Alonso-Rodriguez D, Baron-Esquivias G, Cosin-Sales J, Marin F, Galera-Llorca J, Jimenez N, Marler S, Huisman MV, Lip GYH; Spanish GLORIA-AF investigators. Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program. Med Clin (Barc). 2022 Aug 26;159(4):177-182. doi: 10.1016/j.medcli.2021.09.016. Epub 2021 Dec 8. English, Spanish. PubMed 34895750 ↗
Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15. PubMed 33338644 ↗
Mazurek M, Halperin JL, Huisman MV, Diener HC, Dubner SJ, Ma CS, Rothman KJ, Healey JS, Teutsch C, Paquette M, Franca LR, Lu S, Bartels DB, Lip GYH. Antithrombotic treatment for newly diagnosed atrial fibrillation in relation to patient age: the GLORIA-AF registry programme. Europace. 2020 Jan 1;22(1):47-57. doi: 10.1093/europace/euz278. PubMed 31651951 ↗
Mazurek M, Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Zint K, Franca LR, Lu S, Lip GYH; GLORIA-AF Investigators. Gender Differences in Antithrombotic Treatment for Newly Diagnosed Atrial Fibrillation: The GLORIA-AF Registry Program. Am J Med. 2018 Aug;131(8):945-955.e3. doi: 10.1016/j.amjmed.2018.03.024. Epub 2018 Apr 11. PubMed 29654720 ↗
Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31. PubMed 29653649 ↗
Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Bartels DB, Lip GY; GLORIA-AF Investigators. The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2. J Am Coll Cardiol. 2017 Feb 21;69(7):777-785. doi: 10.1016/j.jacc.2016.11.061. PubMed 28209218 ↗
Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19. PubMed 24576516 ↗

Study documents

Statistical analysis plan ↗ · Nov 9, 2018
Study protocol ↗ · Jun 7, 2013

PDFs hosted by the registry, ClinicalTrials.gov.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01468701
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Nov 9, 2011
Start date: Nov 7, 2011
Primary completion: Jan 10, 2020
Completion: Jan 10, 2020
Results posted: Mar 29, 2021
Last update: Mar 29, 2021

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke →

Other studies from this sponsor

Boehringer Ingelheim →

Start the discussion

GLORIA-AF Registry Program - Second and Third Phases

Study summary

Conditions studied

Browse trials for

In context

Stroke

Lead sponsor

Who can participate

Study population

✓Inclusion criteria

✕Exclusion criteria

Study design

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Related links

Study documents

Updates

Registry details

Key details

Study contacts

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria