The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an additional indication for Plavix (clopidogrel) in adult patients with a high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS). This new indication includes Plavix used alongside aspirin within 24 hours of an event and continued for 21 days, followed by long-term single anti-platelet therapy.
The additional indication is based on the results of two double-blind, randomized, placebo-controlled investigator-initiated Phase 3 trials involving more than 10,000 patients, which showed that the combination of Plavix and aspirin initiated within 24 hours is superior to aspirin alone for reducing the risk of subsequent stroke, with an overall acceptable safety profile.
“Reducing the risk of ischemic stroke is an immediate priority in patients experiencing minor IS or high-risk TIA, as the risk of recurrence is particularly high in the first few weeks,” said Sandra Silvestri, M.D., PhD, Global Head of Medical, General Medicines at Sanofi. “This new indication builds on 20 years of use of Plavix in secondary prevention of atherothromboses, such as ischemic stroke or acute coronary syndrome, and reflects Sanofi’s unwavering commitment to advance care for people living with a cardiovascular disease.”
In an international population, the POINT study tested the combination of Plavix and aspirin on 4,881 patients, finding that 25% fewer people suffered major ischemic events after treatment with Plavix and aspirin compared with treatment with aspirin alone (5.0% vs 6.5%; HR: 0.75; 95% CI: 0.59 to 0.95; p=0.02).
In the CHANCE study, which randomized 5,170 patients in China after an initial minor IS or high-risk TIA event, 32% fewer people treated with Plavix and aspirin suffered subsequent strokes compared with those treated with aspirin alone (8.2% vs 11.7%; Hazard ratio (HR): 0.68; 95% confidence interval (CI): 0.57 to 0.81; p<0.001) at 90 days.