Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043991
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
University Hospital, Montpellier

September 22, 2009
January 7, 2010
June 1, 2016
December 2008
July 2010   (Final data collection date for primary outcome measure)
Magnetic resonance imaging (MRI) determination of infarct size [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01043991 on Archive Site
  • Cardiac enzymes [ Time Frame: 12 weeks ]
  • Echocardiography [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"
Intracoronary Injection of Epo During Reperfusion in Patients Hospitalized for First Acute Myocardial Infarct STEMI

Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI), able to reduce infarct size ?

In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic compounds, when given during reperfusion, after cardiac ischemia. In humans, post-conditioning offers such a protection, as the investigators have previously showed (Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).

Infarct size reduction could lead to a reduced rate of complications (heart failure, rhythmic complications) and finally, morbidity and even mortality. This protection depends on anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or difficult to manage (insulin, morphin). One of the most promising agent could then be erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting heart. Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO impact is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the human myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase and ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test this hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion injury. This impact could rely on anti-apoptotic properties.

Multiple Centers.:

5 centers located in France:

  • Montpellier
  • Clermont-Ferrand
  • Lyon
  • Marseille
  • Nîmes

Study design: Open-label, placebo-controlled, single-blinded. Patient in treatment group will receive intracoronary single bolus of EPO (150 µg), as soon as significant reperfusion is obtained (as measured by TIMI flow 2 or 3). In control group, placebo will be used. Placebo must be presented exactly the same as the drug.

Length of Treatment: One shot during reperfusion procedure.

Follow-up Period: 72nd hour post-admission for plasma kinetics of cardiac enzymes 5th to 7th day after revascularization procedure for MRI measurements, and echocardiography3th month post-MI MRI, echocardiography3th month: phone contact.

Sample Size: 27 patients in each arm, 54 patients total.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Acute Myocardial Infarct
  • Drug: Darbepoetin alfa
  • Drug: Placebo
  • Experimental: EPO
    single bolus of EPO, 150 µg
    Intervention: Drug: Darbepoetin alfa
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Roubille F, Micheau A, Combes S, Thibaut S, Souteyrand G, Cayla G, Bonello L, Lesavre N, Sportouch-Dukhan C, Klein F, Berboucha S, Cade S, Cung TT, Raczka F, Macia JC, Gervasoni R, Cransac F, Leclercq F, Barrère-Lemaire S, Paganelli F, Mottref P, Vernhet Kovacsik H, Ovize M, Piot C. Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: results of the randomized Intra-Co-EpoMI trial. Arch Cardiovasc Dis. 2013 Mar;106(3):135-45. doi: 10.1016/j.acvd.2012.12.001. Epub 2013 Feb 1.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2011
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ACS with persistent ST elevation
  • First episode
  • Symptoms onset < 12 hours
  • Eligible for angioplasty
  • Culprit coronary artery occluded (TIMI flow 0-1) at admission, and then adequately reperfused (TIMI flow 2-3) prior to EPO injection

Exclusion Criteria:

  • Cardiogenic shock
  • Cardiac arrest
  • Currently receiving EPO
  • Pregnancy
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: Christophe PIOT, Pr Montpellier University Hospital
University Hospital, Montpellier
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP