Clinical trial NCT00648089: EPOMI Study: ErythroPOietin in Myocardial Infarction
Official title: ErythroPOietin in Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Keywords: Acute ST Elevation Myocardial Infarction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Fédération Française de Cardiologie
name: Société Française de Cardiologie
First posted: 2008-04-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication
timeFrame: within 3-7 days of administration of study medication
Secondary outcomes:
measure: End-systolic volume, end-diastolic volume, ejection fraction
timeFrame: within 3-7 days of administration of study medication, and 3 months later
measure: Changes in hemoglobin, platelets, reticulocytes blood count
timeFrame: during the first 10 days following study medication administration
measure: Occurrence of major cardiac event or venous thrombotic events
timeFrame: within 12 months following administration of study medication
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Angers
country: France
facility: Fabrice PRUNIER, MD, PhD,
Study officials:
affiliation: University Hospital, Angers
name: Fabrice PRUNIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prunier F, Biere L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genee O, Guerin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delepine S, Benard T, Furber A. Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial. Am Heart J. 2012 Feb;163(2):200-7.e1. doi: 10.1016/j.ahj.2011.11.005.