Warfarin Versus Aspirin Recurrent Stroke Study

Study Overview
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Brief Summary
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The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.

Detailed Description
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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.

Official Title
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A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Active Aspirin
* Drug: Active Warfarin
* Drug: Aspirin placebo
* Drug: Warfarin placebo


Participation Criteria
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Eligibility Criteria
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Inclusion: Acceptable candidates for warfarin therapy 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Warfarin and Aspirin Placebo<br>One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo. | Drug: Active Warfarin<br>* 2mg scored tablet daily<br>Drug: Aspirin placebo<br>* 325mg aspirin placebo pill<br>|
| Active Comparator: Active Aspirin and Warfarin Placebo<br>One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo. | Drug: Active Aspirin<br>* 325mg tablet daily<br>Drug: Warfarin placebo<br>* 2mg scored placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, aspirin, warfarin