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EPOMI Study: ErythroPOietin in Myocardial Infarction (EPOMI)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
EPO
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Angers
  • Fabrice PRUNIER, MD, PhD,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication

Secondary Outcome Measures

End-systolic volume, end-diastolic volume, ejection fraction
Changes in hemoglobin, platelets, reticulocytes blood count
Occurrence of major cardiac event or venous thrombotic events

Full Information

First Posted
March 27, 2008
Last Updated
January 28, 2011
Sponsor
University Hospital, Angers
Collaborators
Fédération Française de Cardiologie, Société Française de Cardiologie
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1. Study Identification

Unique Protocol Identification Number
NCT00648089
Brief Title
EPOMI Study: ErythroPOietin in Myocardial Infarction
Acronym
EPOMI
Official Title
ErythroPOietin in Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Angers
Collaborators
Fédération Française de Cardiologie, Société Française de Cardiologie

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Acute ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
EPO
Intervention Description
Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
End-systolic volume, end-diastolic volume, ejection fraction
Time Frame
within 3-7 days of administration of study medication, and 3 months later
Title
Changes in hemoglobin, platelets, reticulocytes blood count
Time Frame
during the first 10 days following study medication administration
Title
Occurrence of major cardiac event or venous thrombotic events
Time Frame
within 12 months following administration of study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice PRUNIER, MD, PhD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Fabrice PRUNIER, MD, PhD,
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22305837
Citation
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.
Results Reference
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EPOMI Study: ErythroPOietin in Myocardial Infarction

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