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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Acute ST Elevation Myocardial Infarction

Treatments: Drug: Epoetin alfa

Study type: Interventional

Funder types: NIH

Identifiers

NCT00378352

05-AG-N255 (Other Identifier)

999905255

Details and patient eligibility

About

The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.

Full description

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.

Enrollment: 223 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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223 participants in 2 patient groups, including a placebo group

Dose Escalation Safety

Placebo Comparator group

Description:

The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.

Treatment:

Drug: Epoetin alfa

Single Dose Efficacy

Placebo Comparator group

Description:

Single parenteral administration of 60000 U of epoetin alfa. The objectives of the second phase are to investigate the effects of the highest safe dose on infarct size, left ventricular remodeling and endothelial progenitor cells.

Treatment:

Drug: Epoetin alfa