title: Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial.
abstract: BACKGROUND
  Acute myocardial infarction (MI) remains a leading cause of death despite advances in pharmacologic and percutaneous therapies. Animal models of ischemia/reperfusion have demonstrated that single-dose erythropoietin may reduce infarct size, decrease apoptosis, and increase neovascularization, possibly through mobilization of endothelial progenitor cells.
  
  
  METHODS
  REVEAL is a randomized, double-blind, placebo-controlled, multicenter trial evaluating the effects of epoetin α on infarct size and left ventricular remodeling in patients with large MIs. The trial comprises a dose-escalation safety phase and a single-dose efficacy phase using the highest acceptable epoetin α dose up to 60,000 IU. Up to 250 ST-segment elevation myocardial infarction patients undergoing primary or rescue percutaneous coronary intervention will be randomized to intravenous epoetin α or placebo within 4 hours of successful reperfusion. The primary study end point is infarct size expressed as a percentage of left ventricular mass, as measured by cardiac magnetic resonance imaging 2 to 6 days post study medication administration. Secondary end points will assess changes in endothelial progenitor cell numbers and changes in indices of ventricular remodeling.
  
  
  CONCLUSIONS
  The REVEAL trial will evaluate the safety and efficacy of the highest tolerated single dose of epoetin α in patients who have undergone successful rescue or primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction.
authors.affiliation: Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. chiara.melloni@duke.edu
authors.forename: Chiara
authors.initials: C
authors.lastname: Melloni
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Povsic
authors.forename: Laura
authors.initials: L
authors.lastname: Melton
authors.forename: Raymond J
authors.initials: RJ
authors.lastname: Kim
authors.forename: Rakhi
authors.initials: R
authors.lastname: Kilaru
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
authors.forename: Mark
authors.initials: M
authors.lastname: Talan
authors.forename: Luigi
authors.initials: L
authors.lastname: Ferrucci
authors.forename: Dan L
authors.initials: DL
authors.lastname: Longo
authors.forename: Edward G
authors.initials: EG
authors.lastname: Lakatta
authors.forename: Samer S
authors.initials: SS
authors.lastname: Najjar
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
mesh_terms: D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000187:drug effects / Q000473:pathology* / Q000503:physiopathology; D006397:Hematinics / Q000008:administration & dosage; D006801:Humans; D007275:Injections, Intravenous; D019028:Magnetic Resonance Imaging, Cine; D009203:Myocardial Infarction / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011994:Recombinant Proteins; D020127:Recovery of Function / Q000187:drug effects*; D016896:Treatment Outcome; D014481:United States; D016277:Ventricular Function, Left / Q000187:drug effects* / Q000502:physiology; D020257:Ventricular Remodeling / Q000187:drug effects / Q000502:physiology*
chemical_list: D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa