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Completed

NCT Number: NCT00648089

EPOMI Study: 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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EPO

Drug

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

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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Fédération Française de Cardiologie
  • Société Française de Cardiologie

Registry information

Official study title

ErythroPOietin in Myocardial Infarction

Acronym: EPOMI

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2008
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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