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news.Nuvelo has commenced enrollment in a phase II "proof of concept" clinical trial evaluating its protein compound rNAPc2 as a potential replacement for heparin, a natural blood clot anticoagulant, in patients being treated for acute coronary syndromes.
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Acute coronary syndrome (ACS) occurs when an atherosclerotic plaque ruptures in a coronary artery, which triggers the coagulation cascade resulting in the formation of a blood clot. The clot blocks the flow of blood to the heart muscle, depriving it of oxygen and resulting in unstable angina or heart attack.
“ACS accounts for more than 1 million hospitalizations annually in the US. Improved antithrombotic therapies are needed for the treatment of ACS as a significant number of these patients continue to experience poor outcomes such as angina, heart attack and death with the current standard of care,” said Dr Robert Giugliano, assistant professor in medicine at Harvard Medical School and investigator with the TIMI Study Group.
The study will include from 50 to 100 patients and is being conducted in approximately 25 centers across the US and Canada with the TIMI Study Group. Patients who can be randomized within 48 hours of symptoms will be enrolled in cohorts of 25 patients each. The initial group of patients will receive a half-dose regimen of unfractionated heparin, and 10 micrograms/kg of rNAPc2. The next group will receive no heparin and the same dose of rNAPc2. An additional two cohorts may be added at the discretion of the Operations Committee and the Data Safety Monitoring Board.