Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

Completed

Phase 3 Results

Trial Description

The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: once a day
    ARM 1: Kind: Experimental
    Label: Warfarin
    Description: once a day
  • Dabigatran (Pradaxa)Drug
    Intervention Desc: Dabigatran is an anticoagulant from the class of the direct thrombin inhibitors. It is being studied for various clinical indications, for some of which it may replace warfarin as the preferred anticoagulant. It is orally administered as the prodrug dabigatran etexilate.
  • Dabigatran dose 2 Drug
    Intervention Desc: twice a day
    ARM 1: Kind: Experimental
    Label: Dabigatran dose 2
    Description: twice a day
  • Dabigatran dose 1 Drug
    Intervention Desc: twice daily
    ARM 1: Kind: Experimental
    Label: Dabigatran dose 1
    Description: twice a day

Trial Design

  • Allocation: Randomized
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Active participation in BrainPort training sessions with a Physical Therapist for two 1-hour sessions daily for 5 consecutive days in the clinic, followed by training for 2-20 minute sessions each day at home for 7 weeks. Assessments completed at baseline, 5 days and at end of study (8 weeks).

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of stroke (including hemorrhagic) and systemic embolism.
Secondary Incidence of stroke (including hemorrhagic), systemic embolism, all death Incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, or vascular deaths (including deaths from bleeding)
Primary Yearly Event Rate for Composite Endpoint of Stroke/SEE 36 months No
Secondary Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death 36 months No
Secondary Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death 36 months No
Secondary Bleeding Events (Major and Minor) 36 months Yes
Secondary Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH) 36 months No
Secondary Abnormal Liver Function Test 36 months No

Sponsors