AFASAK I
Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study
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Status:
Trial published in January 1989.
Purpose:
To compare the effects of warfarin, low-dose aspirin, or placebo on the incidence of thromboembolic complications in patients with chronic non-rheumatic atrial fibrillation.
Year Started:
1985
Year Finished:
1988
Design:
Placebo-controlled, randomized trial.
Inclusion Criteria
ECG verified atrial fibrillation.
Exclusion Criteria
Anticoagulation therapy for more than six months, cerebrovascular event within previous 30 days, contraindication for aspirin or warfarin, previous side effects of either medication, pregnancy, blood pressure consistently above 180/100 mm, heart surgery with valve replacement, rheumatic heart disease, alcoholism, sinus rhythm.
Patient Involvement:
Eligible patients were randomized to receive warfarin (openly), or to blindly receive either aspirin (75 mg once daily) or placebo. Follow up exams were performed at three months and six months, then every six months for two years.
Primary Outcome:
Stroke, TIA, or embolic complications at two years.
Secondary Outcome:
Death.
Results:
Patients in the warfarin group (n=335) experienced a total of five thromboembolic complications; patients in the aspirin group (n=336) experienced 20 thromboembolic complications; and patients in the placebo group (n=336) experienced 21 thromboembolic complications. The yearly frequency of events (warfarin at 2.0%; aspirin and placebo at 5.5%) was statistically significant (p>0.05). An intention-to-treat analysis of the 71 total deaths in the study (including those who withdrew from the study) showed no difference in either vascular or total mortality.
Source of Information:
Lancet. 1989 Jan 28;1(8631):175-9.
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This information last updated on: 10/21/2004
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