NCT00648089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 31, 2011

Status Verified

January 1, 2011

Enrollment Period

2.7 years

First QC Date

March 27, 2008

Last Update Submit

January 28, 2011

Conditions

Myocardial Infarction

Keywords

Acute ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

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

    within 3-7 days of administration of study medication

Secondary Outcomes (3)

  • End-systolic volume, end-diastolic volume, ejection fraction

    within 3-7 days of administration of study medication, and 3 months later

  • Changes in hemoglobin, platelets, reticulocytes blood count

    during the first 10 days following study medication administration

  • Occurrence of major cardiac event or venous thrombotic events

    within 12 months following administration of study medication

Study Arms (2)

1

EXPERIMENTAL
Drug: EPO

2

NO INTERVENTION

Interventions

EPODRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Angers

Angers, 49933, France

Location

Fabrice PRUNIER, MD, PhD,

Angers, 49933, France

Location

Related Publications (1)

  • 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.

    PMID: 22305837DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Fabrice PRUNIER, MD, PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 31, 2011

Record last verified: 2011-01

Locations

FR(2)