EPOMI Study: ErythroPOietin in Myocardial Infarction

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Collaborators: Fédération Française de Cardiologie; Société Française de Cardiologie
• Treatments: Epoetin Alfa

Criteria

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.