EPOMI Study: ErythroPOietin in Myocardial Infarction

University Hospital, Angers

Status and phase

Completed

Phase 2

Conditions

Myocardial Infarction

Treatments

Drug: EPO

Study type

Interventional

Funder types

Other

Identifiers

NCT00648089

PHRC 2007-03

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.