The Medicines Company reported results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing percutaneous coronary intervention, PCI. Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization, IDR, or stent thrombosis, ST, at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours. The findings were consistent across all analyzed subgroups of patients, including age, geography, diagnosis at presentation, and the choice of periprocedural anticoagulant. At 30 days, the rate of the composite primary efficacy end point remained significantly lower in the cangrelor group than in the clopidogrel group and the relative reduction in stent thrombosis also persisted. Commenting on the results, Simona Skerjanec PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company, said: "With successful completion and reporting of this Phase 3 trial, our next step is to submit for market approvals in the US and Europe. We anticipate submitting these data for a new drug application to the US Food and Drug Administration in the second quarter with findings of prior trials, including the BRIDGE trial in patients awaiting open heart surgery."
- Pharmaceuticals & Drug Trials