Stroke is one of the important diseases that disproportionately affect African-Americans. African-American men and women are about 2.5 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, and the risk of serious adverse events is low. This is a proposal for a multicenter, randomized, double-blind clinical trial of ticlopidine hydrochloride (500mg/day) and aspirin (1300mg/day) in African-American patients with recent non-cardioembolic ischemic stroke. The primary purpose of the study is to test 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 will be conducted in the Chicago area at 18 sites experienced in the diagnosis and treatment of stroke. 1800 patients will be enrolled over 3- 4 years, and each will be followed 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 in Chicago. 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 Chicago area.
Showing the most recent 10 out of 35 publications
