News:The Medicines Company Discontinues Phase 3 CHAMPION Clinical Trial Program of Cangrelor

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(WikiDoc) - The phase 3 CHAMPION clinical trial program of the investigational agent cangrelor was discontinued today. The intravenous agent was being evaluated in patients undergoing percutaneous coronary intervention (PCI). The announcement was made by the sponsoring company, The Medicines Company, in a press release. In consultation with the Drug Safety Monitoring Board, the independent Interim Analysis Review Committee (IARC) told the sponsor that the CHAMPION-PLATFORM trial would "not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval. This placebo-controlled trial compared treatment with cangrelor (in combination with usual care) to usual care in patients who require PCI." The IARC indicated that "based on updated information, the CHAMPION-PCI trial, a clinical trial comparing treatment with cangrelor to clopidogrel (600 mg loading dose) in patients who require PCI, showed no significant differences in measures of clinical effectiveness." While there was no increase risk of bleeding compared to clopidogrel, there was an increased risk of minor bleeding in comparison to placebo. The program was not discontinued due to safety concerns.