AAASPS
African American Antiplatelet Stroke Prevention Study
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Status:
Enrollment began in 1995 and ceased in October 2001. Trial was halted after interim analysis due to lack of efficacy.
Purpose:
To compare the prophylactic efficacy and safety of ticlopidine and aspirin against secondary stroke, myocardial infarction (MI), and vascular death in African-American patients.
Year Started:
1995
Year Presented:
2003
Design:
Multicenter, two-armed, randomized, double-blind, controlled clinical trial with a planned enrollment of 1800 patients at 90 sites.
Inclusion Criteria
African-American patients between the ages of 29 and 85 who are between 7 and 90 days post-stroke, whose strokes have a non-cardioembolic etiology, and who have a measurable neurological deficit at the time of initial evaluation, are eligible for the study.
Exclusion Criteria
Women of childbearing potential, persons with primary brain hemorrhages, or whose strokes are procedure-related or non-atherosclerotic, who have a Modified Barthel Index < 10 , a mean arterial pressure (MAP) > 130 mmHg, a severe comorbid disease or dementia, transient cerebral ischemia, recent active peptic ulcer disease, lower gastrointestinal bleeding, bleeding diathesis, or who have any other contraindication for aspirin or ticlopidine, are excluded from this study.
Patient Involvement:
Patients will be randomized to receive either ticlopidine 500 mg/day (n=902) or aspirin 650 mg/day (n=907). A complete blood count (CBC) will be drawn and recorded every 2 weeks for the first 3 months. All patients will undergo a minimum of 13 in-person visits and 15 telephone contacts during the 2-year follow-up period.
Primary Outcome:
Recurrent stroke, MI, vascular death
Secondary Outcome:
Neutropenia, thrombocytopenia, gastrointestinal bleeding, hepatic dysfunction
Results:
Ticlopidine had less than 1% efficacy when compared to aspirin and had no statistically significant difference in preventing recurrent stroke, myocardial infarction, or vascular death.
Source of Information:
Abstract, NINDS web page. Stroke. 2000;31:2536. Interim articles published 2001, 2002. Presented at the 28th International Stroke Conference (February 2003). JAMA. 2003;289:2947-2957.
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This information last updated on: 3/24/2009
Reviewed on: 03/24/2009.
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