A Phase 3 interventional study of dabigatran dose 1 and dabigatran dose 2 in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 567 sites in 35 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The purposes of this study are:
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 5,897 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participation in RE-LY, requires long term anticoagulation, provides written informed consent
Exclusion criteria:
Permanent discontinuation of dabigatran during RE-LY
dabigatran high dose twice daily
Drug: dabigatran dose 1
dabigatran low dose twice daily
Drug: dabigatran dose 2
dabigatran high dose twice daily
dabigatran low dose twice daily
Major Bleeding, Annualized Rate of Subjects With Major Bleeds
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: * Bleeding associated with a reduction in hemoglobin of at least 20 g/L * Required transfusion of at least 2 units of blood or packed cells * Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: * Reduction in hemoglobin of at least 50 g/L * Transfusion of at least 4 units of blood or packed cells * Symptomatic intracranial bleeding, either subdural or intracerebral * Associated with hypotension requiring use of intravenous inotropic agents * Required surgical intervention to stop bleeding * Resulted in death
Time frame: up to 43 months
Stroke, Annualized Rate of Subjects With Stroke
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
Time frame: up to 43 months
Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
Time frame: up to 43 months
Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Pulmonary Embolism was generally documented by one of the following: 1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan 2. an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram 3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) 4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
Time frame: up to 43 months
Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
Time frame: up to 43 months
Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deep Vein Thrombosis (DVT) was generally documented by one of the following: 1. abnormal compression ultrasound (CUS), 2. an intraluminal filling defect on venography.
Time frame: up to 43 months
Death, Annualized Rate of Subject Death
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Minor Bleeds
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
Time frame: up to 43 months
Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
| Milestone | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Started | 2927 | 2956 |
| Completed | 2446 | 2438 |
| Not completed | 481 | 518 |
| Withdrew: Major/minor bleed | 30 | 44 |
| Withdrew: Outcome event - other | 33 | 25 |
| Withdrew: Adverse event | 111 | 121 |
| Withdrew: Hospitalization (not including surgery) | 18 | 17 |
| Withdrew: Hospitalization due to surgery | 37 | 40 |
| Withdrew: Reduced creatinine clearance | 53 | 55 |
| Withdrew: Elevated lft results | 7 | 3 |
| Withdrew: Patient refused to take study medication | 65 | 76 |
| Withdrew: Missing | 1 | 0 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Procedure | 6 | 7 |
| Withdrew: Withdrawal by subject | 21 | 25 |
| Withdrew: Site closed | 4 | 3 |
| Withdrew: Physician decision | 47 | 38 |
| Withdrew: Protocol violation | 3 | 11 |
| Withdrew: Patient elected | 7 | 9 |
| Withdrew: Site closed for cause | 19 | 19 |
| Withdrew: Other reason not defined above | 5 | 5 |
| Withdrew: Excluded from analysis | 13 | 19 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: * Bleeding associated with a reduction in hemoglobin of at least 20 g/L * Required transfusion of at least 2 units of blood or packed cells * Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: * Reduction in hemoglobin of at least 50 g/L * Transfusion of at least 4 units of blood or packed cells * Symptomatic intracranial bleeding, either subdural or intracerebral * Associated with hypotension requiring use of intravenous inotropic agents * Required surgical intervention to stop bleeding * Resulted in death
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Major Bleeding, Annualized Rate of Subjects With Major Bleeds | 2.79 | 3.59 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Stroke, Annualized Rate of Subjects With Stroke | 1.39 | 1.26 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE | 0.25 | 0.23 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Pulmonary Embolism was generally documented by one of the following: 1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan 2. an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram 3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) 4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Pulmonary Embolism (PE), Annualized Rate of Subjects With PE | 0.10 | 0.12 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI | 0.72 | 0.66 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deep Vein Thrombosis (DVT) was generally documented by one of the following: 1. abnormal compression ultrasound (CUS), 2. an intraluminal filling defect on venography.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Deep Vein Thrombosis, Annualized Rate of Subjects With DVT | 0.06 | 0.11 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Death, Annualized Rate of Subject Death | 3.18 | 2.99 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) | 1.60 | 1.47 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death | 4.40 | 4.02 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death | 3.51 | 3.32 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed | 6.65 | 7.14 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Annualized Rate of Subjects With Minor Bleeds | 7.49 | 8.98 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) | 9.44 | 11.20 |
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
| percentage of subject-years | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) | 0.28 | 0.33 |
Collected over Up to 43 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran 110 mg | — | 1,028/2,914 (35.3%) | — |
| Dabigatran 150 mg | — | 1,106/2,937 (37.7%) | — |
| Event | Dabigatran 110 mg | Dabigatran 150 mg |
|---|---|---|
| PneumoniaInfections and infestations | 91/2914 | 99/2937 |
| Atrial fibrillationCardiac disorders | 84/2914 | 95/2937 |
| Cardiac failureCardiac disorders | 70/2914 | 87/2937 |
| Cardiac failure congestiveCardiac disorders | 68/2914 | 71/2937 |
| Chest painGeneral disorders | 35/2914 | 47/2937 |
| AnaemiaBlood and lymphatic system disorders | 23/2914 | 36/2937 |
| Angina pectorisCardiac disorders | 34/2914 | 36/2937 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 28/2914 | 36/2937 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 34/2914 | 32/2937 |
| FallInjury, poisoning and procedural complications | 26/2914 | 31/2937 |
SAF - Safety set; included all treated subjects, but excluded subjects from sites 1059 and 0246.
| Age, Continuous(years) | Dabigatran 110 mg | Dabigatran 150 mg | Total |
|---|---|---|---|
| Mean | 73.1 ± 8.4 | 73.1 ± 8.4 | 73.1 ± 8.4 |
| Sex: Female, Male(Participants) | Dabigatran 110 mg | Dabigatran 150 mg | Total |
|---|---|---|---|
| Female | 1000 | 1026 | 2026 |
| Male | 1914 | 1911 | 3825 |
Showing the first 100 of 567 sites across 35 countries.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim