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| Tracking Information | |||||
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| First Received Date ICMJE | November 20, 2001 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00027066 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Warfarin Versus Aspirin Recurrent Stroke Study | ||||
| Official Title ICMJE | |||||
| Brief Summary | The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind | ||||
| Condition ICMJE | Stroke | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2206 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | |||||
| Gender | |||||
| Ages | |||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00027066 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01NS28371 | ||||
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Verification Date | November 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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