An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by Boehringer Ingelheim · Observational
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Among 45 studies in Atrial Fibrillation by Boehringer Ingelheim — none open to participants now, none under way, none of them phase 3. Atrial Fibrillation · Boehringer Ingelheim.
Among the 45 studies in Atrial Fibrillation by Boehringer Ingelheim, this one is the 24th largest by enrollment of the 36 observational ones that give a count, is the only one that started in 2018, is one of 36 observational ones, and was the 39th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →None of the 45 studies in Atrial Fibrillation by Boehringer Ingelheim is open now. The open studies under Atrial Fibrillation, anywhere →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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45 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,489 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Median enrollment 678 across the 9 interventional studies, 5,000 across the 36 observational. Of the 45 that completed or were terminated, 44 (98%) have results posted.
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Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 45 studies in Atrial Fibrillation by Boehringer Ingelheim, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in Sweden) by physicians in several European countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain, Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia, Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.
The aim of this study is to explore the current real world use of dabigatran for stroke prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European patients registered in the SITS registry will be considered; countries of origin are not known a priori.
1000
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Exclusion criteria:
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-valvular atrial fibrillation patients hospitalized with an acute ischemic stroke
Drug: Dabigatran
Oral anticoagulant (NOAC) thrombin inhibitor
Also known as: Pradaxa
Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event)
To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.
Time frame: Up to 3 months of follow-up after index event
National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period
Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event) date, up to 1 day.
Age of Patients According to Dabigatran Initiation Time Period
Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (\>65 years), Drugs and Alcohol Score.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period
Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period
The Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
HAS-BLED of Patients According to Dabigatran Initiation Time Period
The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period
Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians.
Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: Up to 3 months of follow-up after index event.
Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period
Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: At first ever ischaemic stroke (index event), up to 1 day.
Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians
Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: Up to 3 months of follow-up after index event.
Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians
Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
Time frame: Up to 3 months of follow-up after index event.
This retrospective study using existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry assessed the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation after the first ever ischemic stroke (3 months of follow-up thereafter) to prevent secondary stroke.
| Milestone | Total |
|---|---|
| Started | 1489 |
| Completed | 1489 |
| Not completed | 0 |
To evaluate the timing of dabigatran treatment initiation in patients with non-valvular atrial fibrillation (NVAF) after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke.
| Percentage of participants | Total |
|---|---|
| 0 - 24 hours (h) | 5.9 |
| > 24 - 72 h | 15.3 |
| > 3 - 7 days (d) | 27.7 |
| > 7 - 14 d | 33.1 |
| > 14 - 28 d | 14.0 |
| > 28 d - 3 months | 4.0 |
The National Institute of Health Stroke Scale (NIHSS) score on patients with non-valvular atrial fibrillation and dabigatran initiation timing information. The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke. Results were reported according to their dabigatran initiation timing categories.
| Score on a scale | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 8 (5 to 14) | 8 (5 to 14) | 8 (6 to 13) | 12 (7 to 17) | 14 (10 to 18) | 15 (9 to 19) |
Previous Modified Rankin Scale (mRS) collected at first ever ischaemic stroke (index event). The Modified Rankin scale (mRS) is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome. Results were reported according to their dabigatran initiation timing categories.
| Score on a scale | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 1) |
Age of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories. CHA2DS2-VASc and HAS-BLED were used in the statistical analysis. CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/transient ischemic attack(TIA), Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalised ratio (INR), Elderly (\>65 years), Drugs and Alcohol Score.
| Years | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| Age of Patients According to Dabigatran Initiation Time Period | 72 ± 11 | 74 ± 10 | 75 ± 9 | 75 ± 9 | 76 ± 9 | 77 ± 10 |
Diastolic blood pressure (DBP) of patients according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
| millimetre of mercury (mm Hg) | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period | 87 ± 12 | 83 ± 15 | 84 ± 14 | 85 ± 15 | 85 ± 17 | 91 ± 16 |
The Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score of patients according to their start dabigatran time period. CHA2DS2-VASc is used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score ranges from 0 to 9 with 0 being the best outcome. Results were reported according to their dabigatran initiation timing categories.
| Score on a scale | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period | 5 (4 to 6) | 5 (4 to 6) | 5 (4 to 6) | 5 (4 to 6) | 5 (4 to 6) | 5 (4 to 6) |
The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol (HAS-BLED) Score of patients according to their start dabigatran time period. HAS-BLED score ranges from 0 to 9 with higher scores indicating greater risk of bleeding. Results were reported according to their dabigatran initiation timing categories.
| Score on a scale | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| HAS-BLED of Patients According to Dabigatran Initiation Time Period | 3 (2 to 3) | 3 (2 to 3) | 3 (2 to 3) | 3 (2 to 3) | 3 (2 to 3) | 3 (2 to 3) |
Percentage of patients with History of or predisposition to bleeding according to their start dabigatran time period. Results were reported according to their dabigatran initiation timing categories.
| Percentage of participants | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period | 2.1 | 1.1 | 3.0 | 3.0 | 1.8 | 4.4 |
Number of time the corresponding reason to delay oral anticoagulation (OAC) entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
| Times | Total |
|---|---|
| Haemorrhagic transformation | 40 |
| Intracranial Haemorrhage (ICH) Spontaneous | 8 |
| Severity Infarct | 61 |
| Size of Infarct | 52 |
| Location Infarct | 14 |
| Intervention used to treat ischemic stroke | 8 |
| Altered coagulation parameters | 5 |
| Patients bleeding risk factors | 18 |
| Patients stroke risk factors | 6 |
| Patient preference | 4 |
| Recommendation from specialist | 6 |
| Practical considerations | 14 |
| Reason is not specified | 27 |
| Other reasons | 5 |
Physicians' reason to delay dabigatran initiation according to their start dabigatran time period. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
| Times | 0 - 24 Hours | > 24 - 72 Hours | > 3 - 7 Days | > 7 - 14 Days | > 14 - 28 Days | > 28 Days - 3 Months |
|---|---|---|---|---|---|---|
| Haemorrhagic transformation | 0 | 0 | 2 | 2 | 8 | 1 |
| Intracranial Haemorrhage (ICH) pontaneous | 0 | 0 | 0 | 1 | 3 | 0 |
| Severity Infarct | 0 | 0 | 1 | 7 | 12 | 2 |
| Size of Infarct | 0 | 0 | 2 | 9 | 12 | 3 |
| Location Infarct | 0 | 0 | 0 | 3 | 2 | 0 |
| Intervention used to treat ischemic stroke | 0 | 0 | 0 | 2 | 3 | 0 |
| Altered coagulation parameters | 0 | 0 | 0 | 2 | 1 | 0 |
| Patients bleeding risk factors | 0 | 1 | 0 | 4 | 6 | 0 |
| Patients stroke risk factors | 0 | 0 | 0 | 2 | 2 | 1 |
| Recommendation from specialist | 0 | 0 | 0 | 0 | 2 | 1 |
| Practical considerations | 1 | 1 | 0 | 0 | 3 | 3 |
| Reason is not specified | 0 | 0 | 1 | 5 | 4 | 1 |
| Other reasons | 0 | 0 | 0 | 0 | 1 | 0 |
Number of times of corresponding reason of choosing daily dosage of 220 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
| Times | Total |
|---|---|
| Haemorrhagic transformation | 6 |
| Intracranial Haemorrhage (ICH) spontaneous | 3 |
| Severity of stroke | 18 |
| Size of infarct | 13 |
| Location of infarct | 8 |
| Intervention used to treat stroke | 4 |
| Altered coagulation parameters | 7 |
| Patients bleeding risk | 6.3 |
| Patients stroke risk | 27 |
| Recommendation from specialist | 32 |
| Reason is not specified | 95 |
| Other reasons | 10 |
| Patients age | 209 |
| Co-medication | 11 |
| Co-morbidities | 16 |
| Renal function | 48 |
Number of times the corresponding reason for choosing daily dosage of 300 milligram of dabigatran entered by physicians. More than one reasons could be entered for each patient. Index event was defined as the first ever acute ischemic stroke that led to hospital admission for eligible patients.
| Times | Total |
|---|---|
| Intracranial Haemorrhage (ICH) spontaneous | 1 |
| Severity of stroke | 38 |
| Size of infarct | 16 |
| Location of infarct | 18 |
| Intervention used to treat stroke | 3 |
| Altered coagulation parameters | 10 |
| Patients bleeding risk | 34 |
| Patients stroke risk | 89 |
| Recommendation from specialist | 50 |
| Reason is not specified | 216 |
| Other reasons | 1 |
| Patients age | 139 |
| Co-medication | 5 |
| Co-morbidities | 19 |
| Renal function | 47 |
Collected over Adverse event information was not applicable for this study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total | — | — | — |
Patients with non-valvular atrial fibrillation (NVAF) who were initiating dabigatran after hospitalization for first ever ischaemic stroke (the index event) in order to prevent secondary stroke in existing data from the Safe Implementation of Treatments in Stroke (SITS) International Stroke Registry.
| Age, Continuous(Years) | Total |
|---|---|
| Mean | 75 ± 10 |
| Sex: Female, Male(Participants) | Total |
|---|---|
| Female | 788 |
| Male | 701 |
| Race and Ethnicity Not Collected(Participants) | Total |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Nov 2018 to primary completion in Jun 2019, 7 months.
Results were first posted in Jul 2020, 1 year after primary completion.
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