Warfarin Versus Aspirin Recurrent Stroke Study
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|ClinicalTrials.gov Identifier: NCT00027066|
Recruitment Status : Completed
First Posted : November 21, 2001
Last Update Posted : June 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Active Aspirin Drug: Active Warfarin Drug: Aspirin placebo Drug: Warfarin placebo||Phase 3|
This study compared aspirin to warfarin to determine optimal therapy for the prevention of recurrent stroke. Both drugs slow clotting of the blood. Blood clots are involved in the final stages of the most common type of stroke due to blockage of the vessels that supply oxygen-rich blood to the brain. Aspirin affects the blood platelets, while warfarin inhibits circulating clotting proteins in the blood. Numerous previous studies have proven that use of aspirin reduces recurrent stroke by about 25 percent. Part of the controversy about aspirin versus warfarin for stroke prevention has been the thinking among clinicians that warfarin may be a better blood thinner than aspirin to prevent almost all forms of stroke, but that it has greater side effects, increased risk of hemorrhage, and higher costs due to the need for blood tests to monitor the treatment effect for patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke|
|Study Start Date :||June 1993|
|Actual Primary Completion Date :||June 2000|
|Actual Study Completion Date :||November 2001|
Active Comparator: Active Warfarin and Aspirin Placebo
One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.
Drug: Active Warfarin
2mg scored tablet daily
Drug: Aspirin placebo
325mg aspirin placebo pill
Active Comparator: Active Aspirin and Warfarin Placebo
One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.
Drug: Active Aspirin
325mg tablet daily
Drug: Warfarin placebo
2mg scored placebo tablet
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027066
|United States, New York|
|Columbia University Health Sciences|
|New York, New York, United States, 10032|
|Principal Investigator:||J. P. Mohr, M.D.||Columbia University Health Sciences|