HealthDay News — The combination of clopidogrel and aspirin is associated with reduced risk of major ischemic events but increased risk of major hemorrhage among patients with minor ischemic stroke or high-risk transient ischemic attack (TIA), according to a study published online May 16 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the European Stroke Organisation, held from May 16 to 18 in Gothenburg, Sweden.
S. Claiborne Johnston, M.D., Ph.D., from the University of Texas at Austin, and colleagues randomized patients with minor ischemic stroke or high-risk TIA to receive clopidogrel plus aspirin or aspirin alone. A total of 4,881 patients were enrolled at 269 international sites; 2,432 received clopidogrel plus aspirin and 2,449 received aspirin plus placebo.
The trial was halted after enrolling 84 percent of the anticipated number of patients. The researchers found that major ischemic events occurred in 5.0 and 6.5 percent of patients receiving clopidogrel plus aspirin versus aspirin plus placebo, respectively (hazard ratio, 0.75); most events occurred during the first week after the initial event. Major hemorrhage occurred in 0.9 and 0.4 percent of those receiving clopidogrel plus aspirin versus aspirin plus placebo, respectively (hazard ratio, 2.32).
“The study gives us solid evidence that we can use this drug combination to prevent strokes in the highest-risk people, but not without some risk of bleeding,” Johnson said in a statement.
Sanofi provided clopidogrel and placebo for 75 percent of patients in the trial.