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Published on 12/7/2005 in the Prospect News Biotech Daily.

Medicines Co. completes enrollment for phase 3 trial of Angiomax for acute coronary syndrome

New York, Dec. 7 - The Medicines Co. said it completed enrollment of 13,800 patients for its phase 3 Acuity (Acute Catheterization and Urgent Intervention Triage strategY) trial of Angiomax (bivalirudin) in patients with acute coronary syndromes.

The study, at 450 sites in 17 countries, will look at whether Angiomax can replace heparins (unfractionated heparin or enoxaparin). The trial is co-sponsored by Nycomed in Europe.

"The enrollment of over 13,800 patients with acute coronary syndromes into the Acuity trial in just over two years is an incredible achievement and a testament to the importance of improving the otherwise poor prognosis in these high-risk patients," said Acuity's principal investigator, Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center's Center for Interventional Vascular Therapy and vice-chairman of the Cardiovascular Research Foundation, in a news release. "We are hopeful that the results of this landmark trial will establish a new standard of care for patients with unstable coronary artery disease."

The first announcement of results is expected at the American College of Cardiology Annual Scientific Session in March 2006.

The Medicines Co. is based in Parsippany, N.J.


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