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CompletedNCT00648089EPOMIUpdated Jan 31, 2011

EPOMI Study: ErythroPOietin in Myocardial Infarction

A Phase 2 interventional study of EPO in Myocardial Infarction, sponsored by University Hospital, Angers. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-31.

Sponsored by University Hospital, Angers · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • Acute ST Elevation Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 110 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    1

    Drug: EPO

  • No intervention
    2

Interventions

  • DrugEPO

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

06

What researchers measure

Primary outcomes

  1. 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

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

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

  2. Changes in hemoglobin, platelets, reticulocytes blood count

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

  3. Occurrence of major cardiac event or venous thrombotic events

    Time frame: within 12 months following administration of study medication

07

Study locations

2 sites
  • CHU Angers
    Angers, 49933, France
  • Fabrice PRUNIER, MD, PhD,
    Angers, 49933, France
08

References and documents

Publications

  • 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. PubMed 22305837 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00648089
Lead sponsor
University Hospital, Angers
Collaborators
Fédération Française de Cardiologie, Société Française de Cardiologie
First posted
Apr 1, 2008
Start date
Apr 2008
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jan 31, 2011

Study contacts

Fabrice PRUNIER, MD, PhD
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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