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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00004727 |
The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. The study involves more than 50 participating hospitals located throughout the United States. Study medication is provided free of charge, and a transportation stipend is available for those in need.
Condition | Intervention | Phase |
---|---|---|
Stroke Cerebral Infarction |
Drug: aspirin Drug: ticlopidine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind |
Official Title: | African American Antiplatelet Stroke Prevention Study |
Stroke is one of the important diseases that disproportionately affects African-Americans. African-American men and women are about 2 times more likely than whites to die of cerebrovascular disease or experience stroke.
Scientific information about the efficacy and safety of stroke preventatives in this group is much needed, yet African-Americans and other minorities have been underrepresented in biomedical research studies. Preliminary data collected from nonwhite, predominantly African-American patients, suggest that ticlopidine is more effective than aspirin in the secondary prevention of stroke and death for these patients and that the risk of serious adverse events is lower. This is a multicenter, randomized, double-blind clinical trial of ticlopidine hydrochloride (500mg/day) and aspirin (650mg/day) in African-American patients with recent non-cardioembolic ischemic stroke. The primary purpose of the study is to compare the efficacy of ticlopidine and aspirin in the prevention of the outcome endpoints recurrent stroke, vascular death, and myocardial infarction in these African-American patients. Adverse experiences will be studied to further our understanding of the safety of these medications in this group. The study is being conducted at 50 sites experienced in the diagnosis and treatment of stroke. 1800 patients are being enrolled over 3-5 years, and each will be in the study for at least 2 years. Patients will be randomly assigned to treatment at least 7 days, but no more than 90 days after cerebral infarction. The trial promises to provide much needed information about secondary stroke prevention in African-Americans and has the support of established African-American physician, church-based, and community organizations. Enrollment of a substantial number of African-American women is anticipated. Data from these patients will significantly add to our understanding of cerebrovascular disease among black women. Furthermore, the study could also serve as an organizational framework for future studies of stroke prevention or hyperacute treatment in the African-American population.
Ages Eligible for Study: | 29 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Rush-Presbyterian-St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612-3227 |
Principal Investigator: | Philip B. Gorelick, M.D., M.P.H | Rush University Medical Center |
Study ID Numbers: | R01NS33430 |
Study First Received: | February 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004727 History of Changes |
Health Authority: | United States: Federal Government |
African American antiplatelet aspirin ASA acetylsalicylic acid ticlopidine |
prevention stroke cerebral infarction Chicago non-cardioembolic ischemic stroke |
Anti-Inflammatory Agents Ticlopidine Cerebral Infarction Cyclooxygenase Inhibitors Stroke Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia Brain Diseases Cerebrovascular Disorders |
Fibrin Modulating Agents Necrosis Aspirin Analgesics, Non-Narcotic Brain Ischemia Anti-Inflammatory Agents, Non-Steroidal Platelet Aggregation Inhibitors Peripheral Nervous System Agents Analgesics Brain Infarction Antirheumatic Agents Infarction |
Anti-Inflammatory Agents Cerebral Infarction Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Brain Diseases Cerebrovascular Disorders Necrosis Fibrin Modulating Agents Pathologic Processes Aspirin Sensory System Agents Therapeutic Uses Brain Ischemia |
Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Ticlopidine Cyclooxygenase Inhibitors Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Ischemia Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Platelet Aggregation Inhibitors |