To compare low-intensity, fixed-dose warfarin plus aspirin with conventional adjusted-dose warfarin in patients with atrial fibrillation (AF) at high risk of stroke.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Warfarin (Coumadin®)Drug
Other Names: Coumadin Intervention Desc: Anticoagulant (Vitamin K antagonist)
Randomized, clinical trial of 1044 patients at 20 centers in USA and Canada.
Patients were randomized to receive either low-intensity fixed-dose warfarin (INR 1.2-1.5 for initial dose adjustment) and aspirin (325 mg/day) or adjusted-dose warfarin (INR 2.0-3.0).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Ischemic stroke and systemic embolism as measured during monthly telephone interview, clinic follow-up every 3 months, and yearly standard symptom questionnaire..|
|Secondary||Transient ischemic attack, intracranial hemorrhage, disabling or fatal stroke.|