Status:
COMPLETED
EPOMI Study: ErythroPOietin in Myocardial Infarction
Lead Sponsor:
University Hospital, Angers
Collaborating Sponsors:
Fédération Française de Cardiologie
Société Française de Cardiologie
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 acu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00648089
Start Date
April 1 2008
End Date
December 1 2010
Last Update
January 31 2011
Active Locations (2)
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1
CHU Angers
Angers, France, 49933
2
Fabrice PRUNIER, MD, PhD,
Angers, France, 49933