Efficacy Study of Erythropoietin After Revascularization in Myocardial Infarction (REVIVAL-3)
Condition: Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether erythropoietin is superior to placebo with
      respect to left ventricular ejection fraction in patients with ST-elevation myocardial
      infarction undergoing percutaneous coronary intervention.
    

Detailed description: 
      Erythropoietin has lately been shown to exert others than merely hematopoietic functions. Due
      to attenuation of cell apoptosis and necrosis and/or enhancing neovascularisation,
      erythropoietin could be protective after myocardial ischemia and reperfusion and lead to
      infarct size reduction and improvement in left ventricular function. In a controlled clinical
      trial, short-term administration of erythropoietin in patients with ischemic stroke was
      associated with a significantly better functional recovery, with a lower level of circulating
      damage markers and a strong trend to smaller infarct sizes measured by magnetic resonance
      imaging. While leaving hematocrit and platelet counts unchanged, short-term administration of
      erythropoietin was shown to be safe and very well tolerated (no side effects reported or
      observed). The protective effects of short-term erythropoietin in acute ischemic brain damage
      are further evaluated in an ongoing multi-center trial in Germany. Considering the
      preclinical and clinical data erythropoietin is an attractive candidate to be evaluated in
      patients with acute myocardial infarction. In a pilot trial enrolling 22 patients with acute
      myocardial infarction short-term administration of erythropoietin was shown to be safe and to
      significantly increase the level of endothelial progenitor cells after percutaneous coronary
      intervention. However, the very small population did not allow evaluating the benefit in left
      ventricular function or clinical outcomes.

      The aim of the REVIVAL-3 study is to investigate whether there is additional benefit of
      short-term administration of erythropoietin in patients with acute myocardial infarction
      after successful primary percutaneous coronary intervention (PCI) in terms of left
      ventricular ejection fraction.
    

Intervention name(s): Erythropoietin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 33.333 IU of recombinant human erythropoietin beta are given at 3 time points (immediately, 24 hours and 48 hours after percutaneous coronary intervention) providing a cumulative dose of 100.000 IU; Patients will receive placebo immediately, 24 hours and 48 hours after percutaneous coronary intervention.
Other intervention name(s): NeoRecormon; 0.9% NaCl
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: STEMI