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
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: EPO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ErythroPOietin in Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: EPO
Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648089

Locations
France
Fabrice PRUNIER, MD, PhD,
Angers, France, 49933
CHU Angers
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
  More Information

No publications provided by University Hospital, Angers

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fabrice PRUNIER, MD, PhD, University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00648089     History of Changes
Other Study ID Numbers: PHRC 2007-03
Study First Received: March 27, 2008
Last Updated: January 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by University Hospital, Angers:
Acute ST Elevation Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014