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EPOMI Study: ErythroPOietin in Myocardial Infarction

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT00648089
Collaborator
Fédération Française de Cardiologie (Other), Société Française de Cardiologie (Other)
110
Enrollment
2
Locations
2
Arms
32
Duration (Months)
55
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ErythroPOietin in Myocardial Infarction
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: EPO
Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
No Intervention: 2

Outcome Measures

Primary Outcome Measures

  1. 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

  1. End-systolic volume, end-diastolic volume, ejection fraction [within 3-7 days of administration of study medication, and 3 months later]

  2. Changes in hemoglobin, platelets, reticulocytes blood count [during the first 10 days following study medication administration]

  3. Occurrence of major cardiac event or venous thrombotic events [within 12 months following administration of study medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Angers Angers France 49933
2 Fabrice PRUNIER, MD, PhD, Angers France 49933

Sponsors and Collaborators

  • University Hospital, Angers
  • Fédération Française de Cardiologie
  • Société Française de Cardiologie

Investigators

  • Principal Investigator: Fabrice PRUNIER, MD, PhD, University Hospital, Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00648089
Other Study ID Numbers:
  • PHRC 2007-03
First Posted:
Apr 1, 2008
Last Update Posted:
Jan 31, 2011
Last Verified:
Jan 1, 2011
Keywords provided by , ,
Acute ST Elevation Myocardial Infarction
Additional relevant MeSH terms:
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Jan 31, 2011