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TMC Enrolls First Angiomax Patient

Endomax trial begins in PEI patients

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The Medicines Company has enrolled the first patient in a Phase III trial comparing the anticoagulant Angiomax (bivalirudin) to unfractionated heparin (UFH) in patients undergoing peripheral endovascular intervention (PEI).

The Endomax Trial is the first randomized, double-blind, clinical trial to study pharmacology in patients undergoing PEI. PEI is performed in approximately 500,000 patients in the U.S. 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.

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