The Medicines Company's Intravenous Cangrelor Demonstrates 22% Reduction in Ischemic Events Compared to Oral Clopidogrel
Late Breaking Phase 3 CHAMPION PHOENIX Trial Results Presented at American College of Cardiology Scientific Session and Published in The New England Journal of Medicine
SAN FRANCISCO, CA -- 03/10/13 -- The Medicines Company today 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."
The primary safety end point was non-CABG-related severe bleeding, according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria, at 48 hours. Several other bleeding definitions were also applied. More sensitive measures did show an increase in bleeding with cangrelor, though there was no significant difference in the rate of transfusions.
The rate of adverse events related to treatment was similar in the cangrelor and clopidogrel groups (20.2% and 19.1%, respectively; P = 0.13). There were significantly more cases of transient dyspnea with cangrelor than with clopidogrel (1.2% vs 0.3%, P < 0.001), a finding that was also observed in the prior CHAMPION studies.
Presentation and Publication of Results
The results were presented at the American College of Cardiology's 62nd Annual Scientific Session and Expo this morning by Co-Principal Investigator Deepak L. Bhatt, MD, MPH, director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital (BWH) and chief of cardiology at VA Boston Healthcare System, as well as professor of medicine at Harvard Medical School. The other Co-principal investigator of the CHAMPION Trials was Robert A. Harrington, MD, professor and chair of the Department of Medicine at Stanford. The results were concurrently published today in The New England Journal of Medicine.
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting including in patients undergoing percutaneous coronary intervention (PCI). The CHAMPION PHOENIX trial is a double-blind parallel group randomized study that compares cangrelor to a clopidogrel loading dose administered as soon as possible after it is determined that the patient will undergo PCI. In 2011, the Company reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent and receiving a thienopyridine awaiting coronary artery bypass graft (CABG) surgery.
The Medicines Company's website is www.themedicinescompany.com. More detailed data is available at http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol-newsArti...