Myocardial Infarction
Conditions
Keywords
Acute ST Elevation Myocardial Infarction
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.
Interventions
DRUGEPO
Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
Sponsors
Fédération Française de Cardiologie
Société Française de Cardiologie
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Outcome results
None listed