January 8th, 2013
Early Results: Antiplatelet Drug Cangrelor Superior to Clopidogrel in PCI Patients at 48 Hours
The experimental antiplatelet drug cangrelor was superior to traditional clopidogrel in reducing ischemic events at 48 hours in PCI patients, according to the Medicines Company, which is developing the drug. The company today announced positive results from the phase 3 CHAMPION PHOENIX trial, a randomized, double-blind study comparing intravenous cangrelor to oral clopidogrel in PCI patients. The primary endpoint was the composite of death, MI, revascularization, and stent thrombosis at 48 hours.
The trial, which was scheduled to enroll approximately 10,900 patients scheduled for PCI for either stable angina or an acute coronary syndrome (ACS), completed enrollment in October 2012. Robert Harrington and Deepak Bhatt were the co-principal investigators of the trial. “We are looking forward to presenting detailed results to the medical community as soon as the data are fully analyzed,” said Bhatt, in a press release.
In 2009, the company announced the discontinuation of the phase 3 CHAMPION clinical trial program, after the discontinuation of the CHAMPION-PLATFORM and CHAMPION-PCI trials. The drug’s comeback began last year with the positive BRIDGE trial, which randomized 210 ACS or stent patients awaiting CABG and taking a thienopyridine to receive either cangrelor or placebo for at least 48 hours prior to surgery.
Clive Meanwell, the chairman and CEO of the Medicines Company, said that the company would submit data both from the CHAMPION PHOENIX trial and from the BRIDGE trial to regulators in the U.S. and Europe in 2013. “We believe that fast acting and rapidly reversible cangrelor may have an important role to play both in patients undergoing PCI and in patients who need to discontinue oral P2Y12 inhibitors prior to surgery,” he said.