Antiplatelet Therapy to Prevent Stroke in African Americans
Condition: Stroke; Cerebral Infarction
MeSH terms: Stroke; Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): aspirin; ticlopidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Ticlopidine
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: African American; antiplatelet; aspirin; ASA; acetylsalicylic acid; ticlopidine; prevention; stroke; cerebral infarction; Chicago; non-cardioembolic ischemic stroke