CHAMPION Trials With Cangrelor Stopped for Lack of Efficacy

Shelley Wood

May 13, 2009

May 13, 2009 (Parsippany, New Jersey) — The sponsor for the phase 3 CHAMPION-PLATFORM trial, testing cangrelor against placebo in the setting of PCI, is pulling the plug on the study, following a decision by the interim analysis review committee (IARC) that the study would not demonstrate the "persuasive" clinical efficacy needed for regulatory approval [1]. An analysis of a second trial, CHAMPION-PCI, comparing cangrelor with clopidogrel in higher-risk patients requiring PCI, also showed no significant differences in measures of clinical effectiveness.

The Medicines Company (Parsippany, NJ), which was sponsoring the studies, announced today that enrollment had been suspended for both trials. Cangrelor is an intravenous P2Y12 platelet inhibitor that was exclusively licensed from AstraZeneca in December 2003.

According to a press release issued by the study sponsor, the IARC made the decision after consulting with the study's drug safety monitoring board. In terms of safety, the company says adverse-event outcomes were "consistent with those expected from short-term P2Y12 platelet inhibition." These included an increase in minor bleeding among cangrelor-treated patients in the PLATFORM trial, against placebo, but no increased bleeding risk as compared with clopidogrel in the PCI trial.

The company is turning its focus to settings in which an antiplatelet therapy is needed short term, when oral drugs can't be used, or when a short drug half-life is needed--for example, in bridging patients on drugs like clopidogrel who need to go off the drug to undergo surgery. The ongoing BRIDGE study is already investigating this strategy with cangrelor and, according to the press release, will enroll approximately 200 patients.

CHAMPION-PCI was launched in March 2006 and had already enrolled 98% of a planned 9000 patients. CHAMPION-PLATFORM was launched in October 2006 and had enrolled 83% of its planned target of 6400 patients, the release noted.

Drs Bob Harrington and Deepak Bhatt had been leading the CHAMPION trials. Commenting on today's news, Bhatt told heartwire : "We intend to analyze the final, cleaned data and publish the results. We are both grateful to the CHAMPION investigators and patients for their tremendous efforts. I anticipate these results will greatly extend our understanding of both oral and intravenous antiplatelet therapy, especially in the context of other trials that are under way."

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