- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00648089
EPOMI Study: ErythroPOietin in Myocardial Infarction (EPOMI)
January 28, 2011 updated by: University Hospital, Angers
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Angers, France, 49933
- CHU Angers
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Angers, France, 49933
- Fabrice PRUNIER, MD, PhD,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
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No Intervention: 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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within 3-7 days of administration of study medication
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
End-systolic volume, end-diastolic volume, ejection fraction
Time Frame: within 3-7 days of administration of study medication, and 3 months later
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within 3-7 days of administration of study medication, and 3 months later
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Changes in hemoglobin, platelets, reticulocytes blood count
Time Frame: during the first 10 days following study medication administration
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during the first 10 days following study medication administration
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Occurrence of major cardiac event or venous thrombotic events
Time Frame: within 12 months following administration of study medication
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within 12 months following administration of study medication
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabrice Prunier, MD, PhD, University Hospital, Angers
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
March 27, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
January 31, 2011
Last Update Submitted That Met QC Criteria
January 28, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC 2007-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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