Assessment of Pexelizumab in Acute Myocardial Infarction (APEX AMI): A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of pexelizumab in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

The APEX-AMI study represents a major academic/industrial collaboration aimed at recruiting the largest PCI STEMI population ever enrolled in a randomized clinical trial to assess the efficacy of pexelizumab at day-90 mortality. The trial is designed to be innovative, efficient in operations, and performed in the context of routine care. Because it targets a high-risk STEMI population the results will be most informative to clinical practice. A major international collaborative effort is now underway to recruit the targeted population of 8500 patients so as to provide a reliable assessment of the ultimate role of the inflammatory mediator pexelizumab in management of acute MI. The first patient was randomized on July 13, 2004. Study enrollment from 17 countries and more than 300 sites is expected to unfold over the subsequent 2.5 years. © 2005, Elsevier Inc. All rights reserved.