EPOMI Study: ErythroPOietin in Myocardial Infarction

Phase 2

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: EPO

• Registration Number: NCT00648089
• Lead Sponsor: University Hospital, Angers

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-31
• Study Start: 2008-04
• Study First Posted: 2008-04-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-28
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	EPO	-

Primary Outcome Measures

Name	Time	Method
Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication	within 3-7 days of administration of study medication

Secondary Outcome Measures

Name	Time	Method
End-systolic volume, end-diastolic volume, ejection fraction	within 3-7 days of administration of study medication, and 3 months later
Changes in hemoglobin, platelets, reticulocytes blood count	during the first 10 days following study medication administration
Occurrence of major cardiac event or venous thrombotic events	within 12 months following administration of study medication

Trial Locations

Locations (2)

Fabrice PRUNIER, MD, PhD,; 🇫🇷 Angers, France

CHU Angers; 🇫🇷 Angers, France