Approval of clopidogrel in the USA for patients with acute ST-segment elevation myocardial infarction makes it a treatment option for all types of acute coronary syndrome.

The US Food and Drug Administration approved a supplemental new drug application for clopidogrel to reduce the rate of death from any cause and the rate of a combined endpoint of re-infarction, stroke, or death in patients with acute ST-segment elevation myocardial infarction (STEMI).

The benefit of clopidogrel is not known to pertain to patients who receive primary angioplasty.

“Clopidogrel taken with aspirin has previously been shown to reduce the risk of death, recurrent heart attack, or stroke in patients with unstable angina or less severe heart attacks,” said Marc Sabatine, MD, TIMI Study Group, Brigham and Women’s Hospital.

“Now, based on the positive results of two clinical trials, COMMIT and CLARITY-TIMI 28, clopidogrel has been approved by the FDA for use with the most severe types of heart attacks, thereby extending the benefit of clopidogrel to patients across the spectrum of acute coronary syndrome.”

The FDA approval was based on the results of two clinical trials of more than 48,000 patients in which STEMI patients were treated with clopidogrel and aspirin and standard therapy compared with patients treated with placebo and aspirin and standard therapy.

In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) study conducted in China, patients were followed for up to 28 days.

In the CLARITY-TIMI 28 (CLopidogrel as Adjunctive Reperfusion TherapY ? Thombolysis In Myocardial Infarction Study 28) international trial, patients were followed for 30 days.

Results of the COMMIT study demonstrated that in the 28 days following randomization, clopidogrel reduced the relative risk of death in STEMI patients having another occluded artery or a second myocardial infarction or death by day 8 of hospitalization or discharge (event rate, 15.0 percent for clopidogrel versus 21.7 percent for placebo).