To compare the safety and efficacy of aspirin and oral anticoagulation.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Warfarin (Coumadin®)Drug
Other Names: Coumadin; Acenocoumarol Intervention Desc: Anticoagulant (Vitamin K antagonist)
Randomized, open-label, controlled, clinical trial involving 1316 patients at 58 centers.
Patients were randomized to receive open treatment of aspirin (30 mg) or warfarin (INR 3.0 - 4.5).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Death from all vascular causes, or stroke, MI, or bleeding complication as measured every 6 months by clinic visit or telephone.|
|Secondary||Death from all causes, death from vascular causes, and death from vascular causes or nonfatal stroke.|