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).
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.
Andreotti
Felicita
F
Institute of Cardiology, Department of Cardiovascular Medicine, A. Gemelli University Hospital, Largo Gemelli 8, 00168, Rome, Italy. felicita.andreotti@iol.it
Agati
Luciano
L
Conti
Elena
E
Santucci
Eleonora
E
Rio
Teresa
T
Tarantino
Federica
F
Natale
Luigi
L
Berardi
Daniele
D
Mattatelli
Antonella
A
Musumeci
Beatrice
B
Bonomo
Lorenzo
L
Volpe
Massimo
M
Crea
Filippo
F
Autore
Camillo
C
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
D011994:Recombinant Proteins; D004921:Erythropoietin