Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2206 participants
INTERVENTIONAL
1993-06-30
2001-11-30
Brief Summary
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Detailed Description
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To make the aspirin and warfarin arms of the study as unbiased as possible, the investigators matched both groups of patients for primary stroke severity, age, gender, education, and race/ethnicity. The two groups were also matched for stroke risk factors, including hypertension, diabetes, cardiac disease, smoking, alcohol consumption, and physical activity. The investigators used an aspirin dose of 325 mg/day and a warfarin dose specifically tailored to each individual patient.
This study found that aspirin works as well as warfarin in helping to prevent recurrent strokes in most patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Active Warfarin and Aspirin Placebo
One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.
Active Warfarin
2mg scored tablet daily
Aspirin placebo
325mg aspirin placebo pill
Active Aspirin and Warfarin Placebo
One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.
Active Aspirin
325mg tablet daily
Warfarin placebo
2mg scored placebo tablet
Interventions
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Active Aspirin
325mg tablet daily
Active Warfarin
2mg scored tablet daily
Aspirin placebo
325mg aspirin placebo pill
Warfarin placebo
2mg scored placebo tablet
Eligibility Criteria
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Inclusion Criteria
* Had an ischemic stroke within the previous 30 days
* Had scores of 3 or more on the Glasgow Outcome Scale
Exclusion:
* Base-line INR above the normal range (more than 1.4)
* History of stroke due to a procedure or that was attributed to high-grade carotid stenosis for which surgery was planned
* History of stroke associated with an inferred cardioembolic source
30 Years
85 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Columbia University
OTHER
Responsible Party
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Columbia University
Principal Investigators
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J. P. Mohr, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University Health Sciences
Locations
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Columbia University Health Sciences
New York, New York, United States
Countries
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Related Links
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NEJM Article
Other Identifiers
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