Phase 3
Completed N=5,883
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
Source: ClinicalTrials.gov NCT00808067 ↗Enrolled (actual)
5,883
Serious AEs
36.5%
Results posted
Apr 2014
Primary outcomePrimary: Major Bleeding, Annualized Rate of Subjects With Major Bleeds — 2.79; 3.59 percentage of subject-years — p=0.0055
Summary
The purposes of this study are:
1. To evaluate the long-term safety of dabigatran etexilate
2. To assess the effect of a knowledge translation intervention on patient outcomes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Bleeding, Annualized Rate of Subjects With Major Bleeds |
2.79; 3.59 | 0.0055 sig |
| SECONDARY Stroke, Annualized Rate of Subjects With Stroke |
1.39; 1.26 | — |
| SECONDARY Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE |
0.25; 0.23 | — |
| SECONDARY Pulmonary Embolism (PE), Annualized Rate of Subjects With PE |
0.10; 0.12 | — |
| SECONDARY Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI |
0.72; 0.66 | — |
| SECONDARY Deep Vein Thrombosis, Annualized Rate of Subjects With DVT |
0.06; 0.11 | — |
| SECONDARY Death, Annualized Rate of Subject Death |
3.18; 2.99 | — |
| SECONDARY Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) |
1.60; 1.47 | 0.5119 |
| SECONDARY Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death |
4.40; 4.02 | 0.2371 |
| SECONDARY 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 | 0.5052 |
| SECONDARY 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 | 0.2241 |
| SECONDARY Annualized Rate of Subjects With Minor Bleeds |
7.49; 8.98 | — |
| SECONDARY Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) |
9.44; 11.20 | — |
| SECONDARY Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) |
0.28; 0.33 | — |
Eligibility Criteria
Inclusion criteria
Participation in RE-LY, requires long term anticoagulation, provides written informed consent
Exclusion criteria
Permanent discontinuation of dabigatran during RE-LY
Data sourced from ClinicalTrials.gov (NCT00808067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.