The CHAMPION PHOENIX trial has met its protocol defined primary composite efficacy endpoint of death, myocardial infarction, ischemia driven revascularization and stent thrombosis at 48 hours, and has shown that intravenous bolus and infusion of cangrelor provided statistically significant improvement in ischemic events at 48 hours in patients undergoing percutaneous coronary intervention (PCI), according to a statement released Jan. 8 by The Medicines Company, sponsor of the study.
The double-blind parallel group randomized study is a phase 3 clinical trial comparing cangrelor to clopidogrel in patients who require PCI. Cangrelor is an intravenous small molecule antiplatelet agent that blocks the P2Y12 receptor (that has not been approved for commercial use in any market), and is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting. The early results showed that cangrelor demonstrated statistically significant improvement as compared to clopidogrel.
"We are looking forward to presenting detailed results to the medical community as soon as the data are fully analyzed," said Deepak L. Bhatt, MD, MPH, FACC, chief of cardiology at VA Boston Healthcare System and co-principal investigator.
Moving forward, Clive Meanwell, MD, PhD, chairman and chief executive officer of The Medicine Company noted that they expect to submit data from the CHAMPION trial and BRIDGE trial in the U.S. and EU for regulatory review for 2013.