Plavix (clopidogrel), marketed by respective French and US drug majors Sanofi-Aventis and Bristol-Myers Squibb, is more effective when combined with aspirin, than the latter alone in preventing major vascular events in patients with atrial fibrilation who cannot take oral anticoagulants, according to the ACTIVE A the trial presented at the annual scientific session of the American College of Cardiology.
ACTIVE A was a Phase III, double-blind, placebo-controlled trial designed to compare the combination of Plavix 75mg once daily plus aspirin to aspirin alone for preventing the first occurrence of a major vascular event. The study included 7,554 patients with atrial fibrillation who could not take OACs and had at least one major risk factor for stroke.
Findings demonstrated that Plavix plus aspirin significantly reduced major vascular events by 11% over aspirin alone, at a median of 3.6 years of follow-up (6.8% versus 7.6% per year, p=0.01). The greatest benefit was seen in the reduction of stroke, by 28% (2.4% vs 3.3% per year, p<0.001). Other components of major vascular events, such as non-central nervous system systemic embolism, heart attack or vascular death, did not reach statistical significance. Compared to aspirin alone, taking Plavix in addition significantly increased the rate of major bleeding (2.0% vs 1.3% per year, p < 0.001).
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