EPOMI Study: ErythroPOietin in Myocardial Infarction

This study has been completed.
Sponsor:
Collaborators:
Fédération Française de Cardiologie
Société Française de Cardiologie
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00648089
First received: March 27, 2008
Last updated: January 28, 2011
Last verified: January 2011

March 27, 2008
January 28, 2011
April 2008
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00648089 on ClinicalTrials.gov Archive Site
  • End-systolic volume, end-diastolic volume, ejection fraction [ Time Frame: within 3-7 days of administration of study medication, and 3 months later ] [ Designated as safety issue: No ]
  • Changes in hemoglobin, platelets, reticulocytes blood count [ Time Frame: during the first 10 days following study medication administration ] [ Designated as safety issue: Yes ]
  • Occurrence of major cardiac event or venous thrombotic events [ Time Frame: within 12 months following administration of study medication ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
EPOMI Study: ErythroPOietin in Myocardial Infarction
ErythroPOietin in Myocardial Infarction

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
Drug: EPO
Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
  • Experimental: 1
    Intervention: Drug: EPO
  • No Intervention: 2
Prunier F, Bière L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genée O, Guérin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delépine 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00648089
PHRC 2007-03
Yes
Fabrice PRUNIER, MD, PhD, University Hospital, Angers
University Hospital, Angers
  • Fédération Française de Cardiologie
  • Société Française de Cardiologie
Principal Investigator: Fabrice PRUNIER, MD, PhD University Hospital, Angers
University Hospital, Angers
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP