Cangrelor at PCI Cuts Ischemic Events vs Clopidogrel: Preliminary Phase 3 Results

January 08, 2013

PARSIPPANY, New Jersey — The investigational antiplatelet agent cangrelor (the Medicines Company), given as an infusion at PCI, significantly cut the risk of a composite ischemic-event end point at 48 hours compared with the mainstay clopidogrel in a phase 3 randomized trial, the company announced today [1].

Patients in the trial, called CHAMPION PHOENIX, which had a projected enrollment of about 11 000 patients, were undergoing PCI for stable angina or for acute coronary syndromes, including ST-elevation MI. Enrollment was completed in October 2012.

"After successful data lock, the data analysis revealed that the protocol-defined primary composite efficacy end point of death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis at 48 hours was met," said the company in a press release. "Cangrelor demonstrated statistically significant improvement as compared with clopidogrel." In addition, "safety outcomes were similar to those observed in prior trials."

In the announcement, the trial's co–principal investigator Dr Robert A Harrington (Stanford University, CA) said, "We are pleased that the trial delivered such clear results."

The company said the findings will presented in full at an upcoming meeting and that the results of CHAMPION PHOENIX and the BRIDGEtrial will be used to seek regulatory approval in both the US and Europe.

The top-line results from the aptly named new trial may reposition the drug as a risen-from-the-ashes candidate in the setting of PCI. The first major phase 3 trials of cangrelor were CHAMPION-PCIand CHAMPION-PLATFORM, both of which investigated the new IV drug in ACS patients scheduled for PCI. Both were stopped early in 2009 after interim analyses suggested neither study would show a benefit. At the time, investigators pointed out that cangrelor was noninferior to clopidogrel and therefore might have a role in patients who would have difficulty taking oral tablets.

"The main difference among the trials is that in PHOENIX we used a more stringent, rigorous definition of periprocedural MI," Harrington told heartwire . Additional differences between the trials, he added, will be discussed when the results are presented in full.