Warfarin Versus Aspirin Recurrent Stroke Study

Completed

Phase 3 Results

Results

Mean INR 2.0 - 2.1 was sustained over 2 year follow-up. The primary end point of death or recurrent ischemic stroke was reached by 196 of 1103 patients assigned to warfarin (17.8 percent) and 176 of 1103 assigned to aspirin (16.0 percent; P=0.25; hazard ratio comparing warfarin with aspirin, 1.13; 95 percent confidence interval, 0.92 to 1.38). The rates of major hemorrhage were low (2.22 per 100 patient-years in the warfarin group and 1.49 per 100 patient-years in the aspirin group). There were no statistical differences in primary or secondary endpoints or in major hemorrhage.