Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)

Terminated

Phase 3 Results

Trial Description

The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Warfarin (Coumadin®)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: Anticoagulant (Vitamin K antagonist)
  • Clopidogrel (SR25990C) Drug
    Other Names: Plavix®
    Intervention Desc: 75 mg once daily in combination with aspirin

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients were randomized to receive either warfarin (adjusted to an international normalized ratio [INR] of 2.0-3.0, measured at least monthly) or clopidogrel 75 mg/day plus aspirin 75-100 mg/day.

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke, non-central nervous system systemic embolism, MI, and vascular mortality. Safety endpoint: major bleeding.
Secondary Major hemorrhage, total mortality and stroke; individual components of the primary outcome and all safety criteria indluding serious adverse events.
Primary Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death during approximately three years of follow-up No
Secondary Secondary outcomes: major hemorrhage, total mortality and stroke. during approximately three years of follow-up Yes

Sponsors