Ticlopidine Aspirin Stroke Study

Completed

Phase N/A Results

Trial Description

To compare the effects of ticlopidine hydrochloride with those of aspirin on the risk of recurrent stroke or death.

Interventions

Trial Design

Randomized, stratified, double-blind trial of 3069 patients at 56 centers in the U.S. and Canada. Patients were stratified at each center by history of ischemic cardiovascular disease, the occurrence of a moderate or major stroke more than three months before entry, and sex.

Patient Involvement

Patients were randomized to receive ticlopidine hydrochloride (250 mg twice daily) or aspirin (650 mg twice daily). Treatment was continued until the end of the trial (mean of 778 +/- 603 days in the ticlopidine group and 858 +/- 582 days in the aspirin group). Patients were evaluated one month after randomization and then at four-month intervals until the end of the trial.

Outcomes

Type Measure Time Frame Safety Issue
Primary Nonfatal stroke or death from all causes.
Secondary Composite of fatal and nonfatal strokes.

Sponsors

Syntex Research, Palo Alto, CA