WARSS
Warfarin-Aspirin Recurrent Stroke Study
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Status:
Trial complete. Results published 11/01.
Purpose:
To compare warfarin therapy (INR 1.4- 2.8) with platelet antiaggregant therapy for prevention of recurrent stroke.
Location(s):
United States
Year Finished:
2000
Year Presented:
2001
Design:
Randomized, double-blind, trial of 2206 patients at 47 US centers. Trial has four sub-studies: PICSS, APASS, HAS, GENESIS.
Inclusion Criteria
Ischemic stroke presenting within 30 days of entry.
Exclusion Criteria
Patients with cardioembolic source of stroke or symptomatic, operable carotid stenosis, serious morbidity, bleeding complications.
Patient Involvement:
Patients were randomized to receive either aspirin (325 mg/day) or warfarin (INR 1.4-2.8) for at least two years. Blinded management of INRs using real or computer-generated values.
Primary Outcome:
Recurrent ischemic stroke or death from any cause.
Secondary Outcome:
TIAs, MI, adverse experiences (hemorrhage).
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.
Source of Information:
Presented at American Academy of Neurology Meetings, May 2001. N Engl J Med 345:1444-1451.
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This information last updated on: 12/14/2009
Reviewed on: 12/14/2009.
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