To study the value of anticoagulation in the secondary prevention of stroke in patients with non-rheumatic atrial fibrillation.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Warfarin (Coumadin®)Drug
Other Names: Coumadin Intervention Desc: Anticoagulant (Vitamin K antagonist)
Randomized, placebo-controlled, international trial of 455 patients at 108 centers.
Patients eligible for anticoagulation were randomized to receive either open-label oral anticoagulants or double-blind treatment with aspirin or placebo. Patients ineligible for anticoagulation, based on unwillingness of physician or patient, were randomized to receive either double-blind treatment with aspirin (300mg) or matching placebo. Physicians were allowed to choose the type of oral anticoagulant but treatment was adjusted to International Normalized Ratios (INR) or 2.5-4.0.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Vascular death, nonfatal stroke, nonfatal myocardial infarction or systemic embolism assessed every 4 months.|
|Secondary||Death from all causes, non-fatal or fatal stroke of any cause, major thromboembolic events.|