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

Completed

Phase 3 Results

Trial Description

The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.

Conditions

Interventions

  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Piracetam (Nootropil®)Drug
    Intervention Desc: Mechanism of action unknown; increases cerebral blood flow; inhibits platelet aggregation.
  • Placebo Drug
    Intervention Desc: oral administration (tablets)
    ARM 1: Kind: Experimental
    Label: Placebo + ASA
    Description: Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
  • Clopidogrel (SR25990C) Drug
    Other Names: Plavix®
    Intervention Desc: oral administration (tablets)
    ARM 1: Kind: Experimental
    Label: Clopidogrel + ASA
    Description: Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: Drug: clopidogrel (SR25990C) 75 mg once daily in combination with aspirin or Drug: placebo in combination with aspirin.

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary outcome of the ACTIVE A trial: time to the first outcome of stroke, non-Central Nervous System systemic embolism, myocardial infarction or vascular death
Secondary Secondary outcomes of ACTIVE A trial: major hemorrhage, total mortality and stroke
Primary First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication expected median follow-up of approximately 3 years No
Secondary Occurrence of Stroke expected median follow-up of approximately 3 years No
Secondary Death From Any Cause (Cardiovascular and Noncardiovascular) expected median follow-up of approximately 3 years No
Secondary Adjudicated Major Bleedings expected median follow-up of approximately 3 years Yes

Sponsors