Trial · NCT00808067
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
NCT00808067, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-04-08
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial. Trials, record NCT00808067. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00808067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
- NCT number
- NCT00808067
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,897 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- dabigatran dose 1, dabigatran dose 2
- First posted
- 2008-12-15
- Last updated
- 2014-06-09
- Other registries' IDs
- eudract:2008-005248-17
- Results first posted
- 2014-04-08
- Limitations and caveats
- Non-serious adverse events were not collected on subjects in this study.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Bleeding, Annualized Rate of Subjects With Major Bleeds | up to 43 months | 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 |
| Secondary | Stroke, Annualized Rate of Subjects With Stroke | up to 43 months | 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 |
| Secondary | Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE | up to 43 months | 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. |
| Secondary | Pulmonary Embolism (PE), Annualized Rate of Subjects With PE | up to 43 months | 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. |
| Secondary | Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI | up to 43 months | 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. |
| Secondary | Deep Vein Thrombosis, Annualized Rate of Subjects With DVT | up to 43 months | 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. |
| Secondary | Death, Annualized Rate of Subject Death | up to 43 months | 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. |
| Secondary | Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) | up to 43 months | 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. |
| Secondary | Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death | up to 43 months | 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. |
| Secondary | Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death | up to 43 months | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Bleeding, Annualized Rate of Subjects With Major Bleeds | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Stroke, Annualized Rate of Subjects With Stroke | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Pulmonary Embolism (PE), Annualized Rate of Subjects With PE | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Deep Vein Thrombosis, Annualized Rate of Subjects With DVT | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Death, Annualized Rate of Subject Death | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
| SECONDARY | Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death | up to 43 months | SAF-FAS interval | percentage of subject-years | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Bleeding, Annualized Rate of Subjects With Major Bleeds | Dabigatran 110 mg | 2.79 | percentage of subject-years | ||
| Major Bleeding, Annualized Rate of Subjects With Major Bleeds | Dabigatran 150 mg | 3.59 | percentage of subject-years | ||
| Stroke, Annualized Rate of Subjects With Stroke | Dabigatran 110 mg | 1.39 | percentage of subject-years | ||
| Stroke, Annualized Rate of Subjects With Stroke | Dabigatran 150 mg | 1.26 | percentage of subject-years | ||
| Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE | Dabigatran 110 mg | 0.25 | percentage of subject-years | ||
| Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE | Dabigatran 150 mg | 0.23 | percentage of subject-years | ||
| Pulmonary Embolism (PE), Annualized Rate of Subjects With PE | Dabigatran 110 mg | 0.10 | percentage of subject-years | ||
| Pulmonary Embolism (PE), Annualized Rate of Subjects With PE | Dabigatran 150 mg | 0.12 | percentage of subject-years | ||
| Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI | Dabigatran 110 mg | 0.72 | percentage of subject-years | ||
| Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI | Dabigatran 150 mg | 0.66 | percentage of subject-years |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran 110 mg | 2,927 | |
| Overall Study | STARTED | Dabigatran 150 mg | 2,956 | |
| Overall Study | COMPLETED | Dabigatran 110 mg | 2,446 | |
| Overall Study | COMPLETED | Dabigatran 150 mg | 2,438 | |
| Overall Study | NOT COMPLETED | Dabigatran 110 mg | 481 | |
| Overall Study | NOT COMPLETED | Dabigatran 150 mg | 518 |
Source ClinicalTrials.gov
Adverse events1,414
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Dabigatran 110 mg | 23 | 2,914 | |
| serious | Anaemia | Blood and lymphatic system disorders | Dabigatran 150 mg | 36 | 2,937 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Dabigatran 110 mg | 1 | 2,914 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Dabigatran 150 mg | 2 | 2,937 | |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Dabigatran 110 mg | 2 | 2,914 | |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Dabigatran 150 mg | 0 | 2,937 | |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Dabigatran 110 mg | 1 | 2,914 | |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Dabigatran 150 mg | 1 | 2,937 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Dabigatran 110 mg | 1 | 2,914 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Dabigatran 150 mg | 4 | 2,937 |
1 to 10 of 1,414Source ClinicalTrials.gov
See all 1,414 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran 110 mg | ||
| Total, all-cause mortality | Dabigatran 150 mg | ||
| Total, other adverse events | Dabigatran 110 mg | 0 | 0 |
| Total, other adverse events | Dabigatran 150 mg | 0 | 0 |
| Total, serious adverse events | Dabigatran 110 mg | 1,028 | 2,914 |
| Total, serious adverse events | Dabigatran 150 mg | 1,106 | 2,937 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23770747 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dabigatran 110 mg vs Dabigatran 150 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00808067
GET https://conductscience.org/api/trials/v1/NCT00808067/results?page=2