EPOMI Study: ErythroPOietin in Myocardial Infarction

• End-systolic volume, end-diastolic volume, ejection fraction [ Time Frame: within 3-7 days of administration of study medication, and 3 months later ] [ Designated as safety issue: No ]
• Changes in hemoglobin, platelets, reticulocytes blood count [ Time Frame: during the first 10 days following study medication administration ] [ Designated as safety issue: Yes ]
• Occurrence of major cardiac event or venous thrombotic events [ Time Frame: within 12 months following administration of study medication ] [ Designated as safety issue: Yes ]

EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.

• Experimental: 1
  Intervention: Drug: EPO
• No Intervention: 2

Inclusion Criteria:

• ST-Segment elevation myocardial infarction <6h
• Infarct related artery : proximal circumflex artery , proximal and mid left anterior descending artery, 1st segment of the right coronary artery
• TIMI 0 or 1 before angioplasty
• Successful PCI defined by residual stenosis < 50% and TIMI 2 or 3 flow grade
• Body weight : [50-110] kg
• Informed, written consent

Exclusion Criteria:

• Age < 18
• Pregnant, or parturient or breast-feeding women;
• Sexually active women without efficient contraception;
• Inability to fully cooperate with the study protocol
• Pre-treatment with fibrinolysis ;
• Previous Q-wave myocardial infarction or previous aorto-coronary bypass;
• History of deep vein thrombosis or pulmonary embolism;
• Contraindication to aspirin or clopidogrel ;
• Cardiogenic shock ;
• Cardiac resuscitated before angioplasty ;
• Past or active erythropoietin therapy;
• Contraindications to erythropoietin therapy: uncontrolled hypertension, known hypersensitivity to benzoic acid, chronic liver insufficiency, hemoglobin> 16g / l, thrombocytosis, refractory anemia with excess of blasts;
• Renal insufficiency (creatinine clearance <30ml/mn.);
• Active Malignancies
• Any contraindications to magnetic resonance imaging: pacemaker and automatic cardiac defibrillator, hearing aid, neurostimulator, infusion pump etc metallic splinters in the eye, ferromagnetic haemostatic clips in the central nervous system cochlear implants, claustrophobia;
• Allergy to gadolinium ;
• Patient refusal / patient not having provided written informed consent.

• Fédération Française de Cardiologie
• Société Française de Cardiologie