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The Medicines Company
today announced results for its pivotal Phase 3
clinical trial of cangrelor, which 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).
Following the recommendation of the trial's Data Safety Monitoring
Board (DSMB) in July 2012 to continue the protocol as planned, the
CHAMPION PHOENIX trial completed enrollment in October 2012. After successful data lock, the data analysis revealed that the protocol
defined primary composite efficacy endpoint of death, myocardial
infarction, ischemia driven revascularization and stent thrombosis at
48 hours was met. Cangrelor demonstrated statistically significant
improvement as compared to clopidogrel. Safety outcomes were similar
to those observed in prior trials. The trial results are planned to
be presented at a major upcoming scientific meeting.
Commenting on the trial and its conduct, Dr. Robert A. Harrington,
MD, Professor of Medicine and Chairman of Medicine at Stanford
University and Co-Principal Investigator said: "The PHOENIX trial was
designed with careful consideration of the prior studies to determine
whether cangrelor is associated with improved ischemic outcomes
compared with the usual treatment of oral clopidogrel. We are
grateful to the many investigators around the world who enabled rapid
enrollment and the collection of high quality data. We are pleased
that the trial delivered such clear results."
"We are looking forward to presenting detailed results to the medical
community as soon as the data are fully analyzed," said Dr. Deepak L.
Bhatt, MD, MPH, Chief of Cardiology at VA Boston Healthcare System,
Senior Physician at Brigham and Women's Hospital, Professor of
Medicine at Harvard Medical School and Co-Principal Investigator of
the CHAMPION Trials.
Clive Meanwell MD, PhD, Chairman and Chief Executive Officer of The
Medicines Company added that the Company expects to submit data both
from the CHAMPION PHOENIX trial and from the BRIDGE trial in the USA
and EU for regulatory review in 2013. "We believe that fast acting
and rapidly reversible cangrelor may have an important role to play
both in patients undergoing PCI and in patients who need to
discontinue oral P2Y12 inhibitors prior to surgery," he said.
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