REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction

REVEAL is a randomized, double-blinded, placebo-controlled, parallel phase II clinical study
that will evaluate the effects of erythropoietin 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 and who agree to participate in this study will be randomly
assigned to receive a single infusion of study medication consisting either of
erythropoietin or placebo. The size of the infarction and the dimensions of the heart will
be assessed by cardiac magnetic resonance imaging (MRI) within 2-6 days of the infusion of
the study medication, and again approximately 3 months later.

- INCLUSION CRITERIA:

Age greater than 21 years

Acute ST-elevation myocardial infarction

Referral for primary or rescue angioplasty

Revascularization procedure within 8 hours from the onset of ischemic symptoms

TIMI (Thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary
artery at the beginning of coronary angiography

Successful revascularization of infarct-related artery

EXCLUSION CRITERIA:

Clinical indication for erythropoietin

STEMI (ST-elevation myocardial infarction) due to occlusion of a branch vessel

Any history of prior MI, PCI (Percutaneous coronary intervention), CABG (Coronary artery
bypass graft), cardiomyopathy, myocarditis, or CHF (congestive heart failure)

Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin

Hematocrit greater than 42% in men or greater than 40% in women at the time of study drug
administration

Uncontrolled hypertension at the time of study drug administration

Cardiogenic shock

Need for coronary surgical revascularization as determined at the time of the index
coronary catheterization

History of hypercoagulable disorder, thromboembolic event, or venous thrombosis

History of stroke or TIA (transient ischemic attack)

History of seizures

Contraindication to MRI

Pregnancy or nursing mother