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| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00027066 |
Purpose
The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: Active Aspirin Drug: Active Warfarin Drug: Aspirin placebo Drug: Warfarin placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke |
| Estimated Enrollment: | 2206 |
| Study Start Date: | June 1993 |
| Study Completion Date: | November 2001 |
| Primary Completion Date: | June 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Jay Preston Mohr, MD, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00027066 History of Changes |
| Other Study ID Numbers: | R01NS28371, R01NS028371 |
| Study First Received: | November 20, 2001 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
stroke aspirin warfarin |
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Aspirin Warfarin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |