The Medicines Company's Intravenous Cangrelor Demonstrates 22% Reduction in Ischemic Events Compared to Oral Clopidogrel
SAN FRANCISCO, CA--(Marketwire - Mar 10, 2013) - The Medicines Company (
Detailed findings include:
|Endpoints at 48 hours||Cangrelor*
(n = 5470)
|Key Secondary||Stent thrombosis||0.8%||1.4%||38%||0.01|
|Death or ST||1.1%||1.6%||33%||0.02|
|Incidence of primary endpoint in selected subgroups:|
|Clopidogrel loading dose||300 mg (n=2806)||5.8%||6.8%||16%||0.27|
|600 mg (n=8133)||4.3%||5.6%||23%||0.009|
|Timing of loading dose||Before PCI (n=6902)||4.8%||6.0%||20%||0.033|
|After PCI (n=3976)||4.3%||5.4%||21%||0.12|
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.
(n = 5527)
|Major or minor||0.3%||0.1%||1.75(0.73-4.18)||0.20|
|Major w/out hematoma||0.8%||0.5%||1.62(0.99,2.64)||0.05|
|Any blood transfusion||0.5%||0.3%||1.56(0.83-2.93)||0.16|
|Efficacy and safety: net adverse clinical events**|
|Death, myocardial infarction, ischemia-driven revascularization, stent thrombosis, or GUSTO-defined severe bleeding||4.8%||6.0%||0.80(0.67-0.94)||0.008|
**The primary efficacy and primary safety end points were combined to provide a composite end point of net adverse clinical events in the modified intention-to-treat population.
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.
There will be a conference call with MDCO management and experts today at 11:00 a.m. Pacific Time (2:00 p.m. Eastern Time) to discuss cangrelor trial results and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at www.themedicinescompany.com. The dial in information is listed below:
Domestic Dial In: 866 700.6067
International Dial In: 617 213.8834
Passcode for both dial in numbers: 54431050
Replay is available from 4:00 p.m. Eastern Time following the conference call through March 17, 2013. To hear a replay of the call, dial 888 286.8010 (domestic) and 617 801.6888 (international). Passcode for both dial in numbers is 17733784.
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.
About The Medicines Company
The Medicines Company (
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