To define the benefits and risks associated with warfarin compared with aspirin in a large number of patients followed for a longer period of time (compared to SPAF I) according to age and inherent risk of thromboembolism.
- Warfarin (Coumadin®)Drug
Other Names: Coumadin; Acenocoumarol Intervention Desc: Anticoagulant (Vitamin K antagonist)
Two parallel, randomized, placebo-controlled clinical trials of 1100 patients at 16 U.S. centers. One trial studied patients >75 years of age, the other <=75.
Patients were randomized to receive warfarin or aspirin (325 mg daily).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Ischemic stroke and systematic embolism as assessed every 3 months|
|Secondary||Effect of therapies on all strokes with residual functional deficit (ischemic or hemorrhagic) and primary events plus vascular death. Also, reduction of primary events among patients considered to be at high inherent risk for thromboembolism.|