EPOMI Study: ErythroPOietin in Myocardial Infarction

Myocardial Infarction Clinical Trial

— EPOMI  

Official title:

ErythroPOietin in Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648089
• Other study ID #: PHRC 2007-03
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2008
• Last updated: January 28, 2011
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• EPO
Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Fabrice PRUNIER, MD, PhD,	Angers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Fédération Française de Cardiologie, Société Française de Cardiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	End-systolic volume, end-diastolic volume, ejection fraction		within 3-7 days of administration of study medication, and 3 months later	No
Secondary	Changes in hemoglobin, platelets, reticulocytes blood count		during the first 10 days following study medication administration	Yes
Secondary	Occurrence of major cardiac event or venous thrombotic events		within 12 months following administration of study medication	Yes