title: Update on phase II studies of erythropoietin in acute myocardial infarction. Rationale and design of Exogenous erythroPoietin in Acute Myocardial Infarction: New Outlook aNd Dose Association Study (EPAMINONDAS).
abstract: Erythropoietin (Epo) is a hematopoietic hormone produced mainly by the kidneys in response to hypoxia. Recent acquisitions in the fields of hematology, neurology, cardiology, and experimental medicine show cytoprotective, angiogenetic and antiinflammatory effects of Epo. Exogenous erythroPoietin in Acute Myocardial Infarction: New Outlook aNd Dose Association Study (EPAMINONDAS, EudraCTno. 200500485386) is one of four ongoing randomized controlled trials, each testing the effects of Epo in >or=100 patients with STEMI. EPAMINONDAS is a multicenter, prospective, double-blind, placebo-controlled, dose-finding study assessing intravenous moderate doses of human recombinant Epo (epoietin-alpha, 100 or 200 IU/kg/die) versus placebo, given on the first 3 days, in 102 patients with first ST-segment elevation myocardial infarction. Initial dosing is within 12 h of primary percutaneous coronary revascularization. The primary endpoint is infarct size, quantified by CK-MB time-concentration curve, left ventricular wall motion score index, and pattern of contrast-enhanced magnetic resonance imaging. Secondary endpoints are ischemic recurrences, ventricular remodelling, and safety events, assessed in-hospital and at 12 months' follow-up. The results of current phase II studies will help define the safety/efficacy profile of Epo for patients with STEMI.
authors.affiliation: Institute of Cardiology, Department of Cardiovascular Medicine, A. Gemelli University Hospital, Largo Gemelli 8, 00168, Rome, Italy. felicita.andreotti@iol.it
authors.forename: Felicita
authors.initials: F
authors.lastname: Andreotti
authors.forename: Luciano
authors.initials: L
authors.lastname: Agati
authors.forename: Elena
authors.initials: E
authors.lastname: Conti
authors.forename: Eleonora
authors.initials: E
authors.lastname: Santucci
authors.forename: Teresa
authors.initials: T
authors.lastname: Rio
authors.forename: Federica
authors.initials: F
authors.lastname: Tarantino
authors.forename: Luigi
authors.initials: L
authors.lastname: Natale
authors.forename: Daniele
authors.initials: D
authors.lastname: Berardi
authors.forename: Antonella
authors.initials: A
authors.lastname: Mattatelli
authors.forename: Beatrice
authors.initials: B
authors.lastname: Musumeci
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Bonomo
authors.forename: Massimo
authors.initials: M
authors.lastname: Volpe
authors.forename: Filippo
authors.initials: F
authors.lastname: Crea
authors.forename: Camillo
authors.initials: C
authors.lastname: Autore
mesh_terms: D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011994:Recombinant Proteins; D012107:Research Design
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin