Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"
Condition: Acute Myocardial Infarct
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Darbepoetin alfa; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: STEMI; AMI,; acute myocardial infarct; Epo; Erythropoietin; ischemia-reperfusion; apoptosis