First Patient Enrolled in Phase III Trial Evaluating The Medicines Company’s Angiomax


in III The Company’s (R) (Bivalirudin) in Patients Undergoing Peripheral Endovascular Procedures

NEW YORK, NY — (Marketwired) — 10/09/13 — The Medicines Company (NASDAQ: MDCO) today reported enrollment of the first patient in a Phase III clinical trial comparing the anticoagulant Angiomax® (bivalirudin) to unfractionated heparin (UFH) in patients undergoing peripheral endovascular intervention (PEI). The Endomax Trial (ENDOvascular interventions with AngioMAX (bivalirudin)) is the first randomized, double blind, clinical trial to study pharmacology in patients undergoing Peripheral Endovascular Intervention (PEI). PEI is performed in approximately 500,000 patients in the United States each year. Angiomax is currently approved for use in patients undergoing angioplasty, also called percutaneous coronary intervention (PCI). The Medicines Company intends to pursue labeling expansion in the PEI setting.

The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications (at 48 hours post procedure) compared with UFH in subjects undergoing PEI. The secondary objective is to identify potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.

The Medicines Company will announce details of the trial at its Investor & Analyst Day in New York today from 8:30ET to noon. The meeting is webcast with a link available at

Principal Investigator for the trial, Barry Katzen, MD, Founder and Medical Director of Baptist Cardiac and Vascular Institute in Miami…Read more

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