The global phase III study has enrolled13,800 patients to help evaluate Angiomax (bivalirudin) as a replacement to the commonly used anticoagulant heparin in patients with acute coronary syndromes. Angiomax is a direct thrombin inhibitor, which will be given to patients at emergency departments in 450 different trial sites in 17 countries worldwide.
The control arm of the trial is comprised of patients treated with the heparins combined with glycoprotein (GP IIb/IIIa) inhibitors, which are intravenous antiplatelet agents. In the other two arms of the trial, Angiomax is being evaluated alone and with the use of GP IIb/IIIa inhibitors.
“We are hopeful that the results of this landmark trial will establish a new standard of care for patients with unstable coronary artery disease,” said Dr Gregg Stone, professor of medicine at Columbia University Medical Center and principal investigator for the study
In the US each year, 1.8 million patients are hospitalized for ACS, according to The Medicines Company. Ischemic heart disease patients are subject to chest pain that results from a range of conditions, from unstable angina to acute myocardial infarction. The severe onset of these cardiac conditions is collectively referred to as ACS.