EPOMI Study: ErythroPOietin in Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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ErythroPOietin in Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: EPO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: EPO<br>* Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute ST Elevation Myocardial Infarction