title: Design and rationale of low-dose erythropoietin in patients with ST-segment elevation myocardial infarction (EPO-AMI-II study): a randomized controlled clinical trial.
abstract: OBJECTIVE
  The development of novel pharmaceutical interventions to improve the clinical outcomes of patients with acute ST-segment elevation myocardial infarction (STEMI) is an unmet medical need worldwide. In animal models, a single intravenous administration of erythropoietin (EPO) during reperfusion improves left ventricular (LV) function in the chronic stage. However, the results of recent proof-of-concept trials using high-dose EPO in patients with STEMI are inconsistent. In our pilot study, low-dose EPO after successful percutaneous coronary intervention (PCI) improved the LV ejection fraction (EF) and did not trigger severe adverse clinical events in patients with STEMI. One possible reason for this discrepancy is the dose of EPO used.
  
  
  RESULTS
  We have started a double-blind, placebo-controlled, randomized, multicenter clinical trial (EPO-AMI-II) to clarify the safety and efficacy of low-dose EPO in patients with STEMI. STEMI patients who have a low LVEF (<50 %) will be randomly assigned to intravenous administration of placebo or EPO (6,000 or 12,000 IU) within 6 h after successful PCI. The primary endpoint is the difference in LVEF between the acute and chronic phases (6 months), as measured by single-photon emission computed tomography. The patient number needed for EPO-AMI-II is 600. The study will stop when superior efficacy or futility is detected by an interim analysis. This study has been approved by the Evaluation System of Investigational Medical Care.
  
  
  CONCLUSIONS
  EPO-AMI-II study will clarify the safety and efficacy of low-dose EPO in STEMI patients with LV dysfunction in a double-blind, placebo-controlled, multicenter study. (247 words).
authors.affiliation: Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Minamino
authors.forename: Ken
authors.initials: K
authors.lastname: Toba
authors.forename: Shuichiro
authors.initials: S
authors.lastname: Higo
authors.forename: Daisaku
authors.initials: D
authors.lastname: Nakatani
authors.forename: Shungo
authors.initials: S
authors.lastname: Hikoso
authors.forename: Masao
authors.initials: M
authors.lastname: Umegaki
authors.forename: Kouji
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Sawa
authors.forename: Yoshifusa
authors.initials: Y
authors.lastname: Aizawa
authors.forename: Issei
authors.initials: I
authors.lastname: Komuro
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000601:surgery; D062645:Percutaneous Coronary Intervention; D015427:Reperfusion Injury / Q000517:prevention & control; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy* / Q000601:surgery; D055815:Young Adult
chemical_list: D004921:Erythropoietin