PLAVIX (clopidogrel bisulfate) has been approved for the reduction of atherosclerotic events (myocardial infaraction, stroke, vascular deaths) in patients with atherosclerosis documented by recent myocardial infarctions, recent stroke, or established peripheral arterial disease.
The clearance to market PLAVIX was based primarily on the results of the CAPRIE clinical trial, a randomized, double-blind trial that enrolled 19,185 patients who had suffered a recent ischemic stroke, recent heart attack, or had established peripheral arterial disease.
CAPRIE compared the efficacy and safety of clopidogrel and aspirin in reducing subsequent strokes, heart attacks, and other vascular events in patients treated for a period of one to three years.
PLAVIX is contraindicated in patients with active pathologic bleeding or who have shown hypersensitivity to the drug or any component of the drug and should be used with caution in patients with severe liver disease. The most frequent side effects are rash, diarrhea, and pruritis.