African American antiplatelet stroke prevention study: Clinical trial design

Area of Science:

• Neurology
• Cardiovascular Medicine
• Clinical Trials

Background:

• African Americans experience a disproportionately high rate of cerebrovascular disease and stroke mortality compared to European Americans.
• Historically, this demographic has been underrepresented in clinical trials, limiting evidence-based treatment guidelines.
• Cerebrovascular disease significantly impacts survival rates within the African American community.

Purpose of the Study:

• To compare the efficacy of ticlopidine versus aspirin in preventing recurrent stroke, myocardial infarction, and vascular death.
• To provide crucial secondary stroke prevention data specifically for African American patients.
• To address the underrepresentation of African Americans in clinical research for stroke prevention.

Main Methods:

• The African American Antiplatelet Stroke Prevention Study (AAASPS) is a multi-center, randomized, double-blind trial.
• 1,800 African American patients with recent noncardioembolic ischemic stroke will be randomized to receive ticlopidine or aspirin.
• Patients will be followed for 2 years, with safety monitoring for neutropenia, thrombocytopenia, and bleeding events.

Main Results:

• The study is designed to determine the primary outcome cluster of recurrent stroke, myocardial infarction, and vascular death.
• Safety analyses will focus on severe adverse events, including neutropenia, thrombocytopenia, gastrointestinal bleeding, and liver dysfunction.
• Intention-to-treat and time-to-event analyses will be employed for endpoint evaluations.

Conclusions:

• The AAASPS is the pioneering secondary stroke prevention study exclusively enrolling African Americans.
• Results are anticipated to offer vital insights for optimizing recurrent stroke prevention strategies in this vulnerable population.
• The study aims to reduce the survival disadvantage linked to stroke in African Americans.