Conditions: Atrial Fibrillation Vascular Risk
Keywords: Atrial fibrillation Anticoagulant therapy Thromboembolic prevention
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7554
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) arm 2: Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)

Interventions: intervention 1: clopidogrel (SR25990C) intervention 2: placebo
Intervention descriptions: intervention 1: oral administration (tablets) intervention 2: oral administration (tablets)

Protocol document: