Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial of the Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Acute Myocardial Infarctions (REVEAL)

Numerous pre-clinical studies have shown that erythropoietin has tissue protective effects in animal models of ischemic-reperfu.sion injury to both the central nervous system and to the cardiovascular system. The purpose of this study is to perform a randomized, double- blinded, placebo-controlled, prospective, phase II clinical study that will evaluate the effects of Epoetin alfa (PROCRIT®) administration on infarct size, left ventricular remodeling and circulating endothelial progenitor cells in patients with large myocardial infarctions (MI). The study will be conducted in two phases: a dose-escalation safety phase and a single dose efficacy phase. Eligible patients who present to the hospital with an acute ST-elevation MI (STEMI), and who agree to participate in this study, will be randomly assigned to receive a single infusion of study medication consisting either of Epoetin alfa (PROCRIT®) or placebo. The size of the infarction and the dimensions of the heart will be assessed by cardiac magnetic resonance imaging (Mill) within 2-6 days of the infusion of the study medication, and again approximately 3 months later.