EPOMI Study: ErythroPOietin in Myocardial Infarction

University Hospital, Angers110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Myocardial Infarction

Interventions

EPODRUG

Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

CHU Angers

Angers, France

Fabrice PRUNIER, MD, PhD,

Angers, France

Outcomes

Primary Outcomes

Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication

Time frame: within 3-7 days of administration of study medication

Secondary Outcomes

End-systolic volume, end-diastolic volume, ejection fraction

Time frame: within 3-7 days of administration of study medication, and 3 months later

Changes in hemoglobin, platelets, reticulocytes blood count

Time frame: during the first 10 days following study medication administration

Occurrence of major cardiac event or venous thrombotic events

Time frame: within 12 months following administration of study medication

Data from ClinicalTrials.gov

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