Results Released From Two Major Clinical Trials of Clopidogrel

Results of two major clinical trials showed that the antiplatelet agent clopidogrel, given on top of standard therapy, provided significant benefits to patients with acute ST-segment elevation myocardial infarction (STEMI), a certain kind of heart attack.

The COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) and CLARITY -- TIMI 28 (CLopidogrel as Adjunctive ReperfusIon TherapY -- Thrombolysis In Myocardial Infarction Study 28) trials included a total of nearly 50,000 patients.

In the CLARITY-TIMI 28 trial, clopidogrel added to standard therapy including fibrinolytics and ASA (aspirin) reduced the odds of acute MI patients having another occluded artery, or a second heart attack or death by 36 percent after one week of hospitalization. Additionally, at 30 days, clopidogrel reduced the odds of clinical events in these patients by 20 percent. The results observed with clopidogrel in this clinical setting were consistent irrespective of patients' gender, the standard therapy they received or the location of their MI. The CLARITY-TIMI 28 trial enrolled 3,491 patients at 319 sites in 23 countries in North America, Latin America and Europe.

In the COMMIT/CCS-2 trial clopidogrel, on top of standard therapy including ASA, reduced mortality in acute MI patients. In the 28 days following randomization, clopidogrel reduced the relative risk of death in these patients by 7 percent. In the same patient population, clopidogrel reduced the relative risk of the combination of recurrent MI, stroke or death by 9 percent. The COMMIT/CCS-2 trial, one of the largest randomized, double-blind, placebo-controlled, clinical trials of drug therapy ever conducted in heart disease, enrolled nearly 46,000 patients at 1,250 sites in China.

In both trials, the rates of major bleeding and intracranial hemorrhage were similar in both treatment groups.