EPOMI Study: ErythroPOietin in Myocardial Infarction

NCT ID: NCT00648089

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Keywords

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Acute ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

EPO

Intervention Type DRUG

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

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EPO

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fédération Française de Cardiologie

OTHER

Sponsor Role collaborator

Société Française de Cardiologie

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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University Hospital, Angers

Principal Investigators

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Fabrice PRUNIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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CHU Angers

Angers, , France

Site Status

Fabrice PRUNIER, MD, PhD,

Angers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 22305837 (View on PubMed)

Other Identifiers

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PHRC 2007-03

Identifier Type: -

Identifier Source: org_study_id