Antiplatelet Therapy to Prevent Stroke in African Americans
Antiplatelet Therapy to Prevent Stroke in African Americans
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.
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.
Inclusion Criteria:

 -  African Americans are eligible if they had a non-cardioembolic ischemic stroke at
 lease 7 days, but no more than 90 days before entering the trial.

 -  African American

 -  29-85 years of age

 -  Non-cardioembolic cerebral infarct

 -  Onset of entry stroke at least 7 days but no more than 90 days

 -  CT or MRI following entry stroke and consistent with occurrence of entry stroke (i.e.,
 shows entry infarct, shows old infarct, or shows no infarct) Measurable neurologic
 deficit that correlates with onset of entry stroke.

 -  Informed consent

 -  Able to follow outpatient treatment program

 Exclusion Criteria:

 -  Volunteers with transient ischemic attack (TIA) as the potentially qualifying event,
 intracranial hemorrhage, nonatherosclerotic stroke, sensitivity or major allergy to
 the study drugs, Modified Barthel Index < 10 or childbearing potential are not
 eligible.

 -  Non-qualifying entry events: TIA, subarachnoid hemorrhage, cardiac embolism,
 iatrogenic stroke, postoperative stroke within 30 days of operation, and carotid
 endarterectomy as preventive treatment of entry stroke.

 -  Mean arterial blood pressure > 130mmHg on 3 consecutive days

 -  Modified Barthel Index < 10

 -  History of dementia or neurodegenerative disease

 -  Severe comorbid condition such as cancer that would limit survival during 2 year
 follow-up period

 -  Concurrent enrollment in another clinical trial

 -  Sensitivity or allergy to aspirin or ticlopidine

 -  Women of childbearing potential

 -  Peptic ulcer disease, active bleeding diathesis, lower gastrointestinal bleeding,
 platelet or other hematologic abnormality currently active or clinically active in the
 past year, hematuria, positive stool guaiac, prolonged PT or PTT, BUN > 40mg%, serum
 creatinine > 2.0mg%, thrombocytopenia or neutropenia as defined by the lower limit of
 normal for the platelet count or white blood cell count, respectively (absolute
 neutrophil count of > 1800/mm3 required for participation), or > 2 times the upper
 range of normal on liver function tests (SGOT, SGPT, total bilirubin)