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.
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen Intervention Desc: Antiplatelet agent
- Piracetam (Nootropil®)Drug
Intervention Desc: Mechanism of action unknown; increases cerebral blood flow; inhibits platelet aggregation.
- Placebo Biological
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)
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Prevention
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
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.
|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|