EPOMI Study: ErythroPOietin in Myocardial Infarction - Full Text View

Sponsors and Collaborators:	University Hospital, Angers Fédération Française de Cardiologie Société Française de Cardiologie
Information provided by:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT00648089

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 II

MedlinePlus related topics: Heart Attack MRI Scans

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	ErythroPOietin in Myocardial Infarction

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 ]

Estimated Enrollment:	108
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: EPO Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
2: No Intervention

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

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

Contacts

Contact: Fabrice PRUNIER, MD, PhD

+33241355147

faprunier@chu-angers.fr

Locations

France
Fabrice PRUNIER, MD, PhD,	Not yet recruiting
Angers, France, 49933
Contact: Fabrice PRUNIER, MD, PhD +33241355147 faprunier@chu-angers.fr
CHU Angers	Recruiting
Angers, France, 49933
Contact: Fabrice PRUNIER, MDPhD 33241355147 FaPrunier@chu-angers.fr

Sponsors and Collaborators

University Hospital, Angers

Fédération Française de Cardiologie

Société Française de Cardiologie

Investigators

Principal Investigator:

Fabrice PRUNIER, MD, PhD

CHU d'Angers

More Information

No publications provided

Responsible Party:	University Hospital, Angers ( Fabrice PRUNIER, MD, PhD )
Study ID Numbers:	PHRC 2007-03
Study First Received:	March 27, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00648089
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee

Keywords provided by University Hospital, Angers:

Acute ST Elevation Myocardial Infarction

Study placed in the following topic categories:

Epoetin Alfa
Necrosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Hematinics
Therapeutic Uses

Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 11, 2009