Warfarin Versus Aspirin Recurrent Stroke Study

Phase 3

Completed

• Conditions: Stroke
• Interventions: Drug: Active Warfarin; Drug: Active Aspirin; Drug: Warfarin placebo; Drug: Aspirin placebo

• Registration Number: NCT00027066
• Lead Sponsor: Columbia University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 1993-06
• Primary Completion: 2000-06
• Study Completion: 2001-11
• Study First Submitted: 2001-11-20
• Study First Submitted QC: 2001-11-20
• Study First Posted: 2001-11-21
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Aspirin and Warfarin Placebo	Warfarin placebo	One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.
Active Warfarin and Aspirin Placebo	Active Warfarin	One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.
Active Warfarin and Aspirin Placebo	Aspirin placebo	One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.
Active Aspirin and Warfarin Placebo	Active Aspirin	One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.

Trial Locations

Locations (1)

Columbia University Health Sciences; 🇺🇸 New York, New York, United States