Antiplatelet Therapy to Prevent Stroke in African Americans


Phase 4 Results

Eligibility Criteria

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)