Scientific Tracks Abstracts: Transl Med
The development of novel pharmaceutical intervention to improve the clinical outcomes in patients with acute ST-segment elevated myocardial infarction (STEMI) is the world-wide unmet medical need. In animal models, we demonstrated that a single intravenous administration of erythropoietin (EPO) during reperfusion improves left ventricular (LV) function in the chronic stage. However, the results of recent ï¿½proof-of-conceptï¿½ trials using a high-dose of EPO in patients with STEMI were inconsistent. In our clinical pilot study (EPO-AMI-I), a low-dose of EPO after successful percutaneous coronary intervention (PCI) improved LV ejection fraction (EF) in patients with STEMI. The administration of did not trigger any adverse clinical events. One possible reason for this discrepancy is due to the dose of erythropoietin used. Thus, we have started a double-blind, placebo-controlled, randomized multicenter clinical trial (EPO-AMI-II) to clarify the safety and efficacy of a low-dose of EPO on the improvement of LVEF in patients with STEMI. STEMI patients who have low LVEF (<50%) were randomly assigned by a central web-based randomization system to intravenous administration of placebo, or EPO (6,000 or 12,000 IU) within 6 hours of successful PCI. The primary endpoint was the difference between the acute and chronic phase (6 months) regarding LVEF as measured on single-photon emission computed tomography. The patient number needed for EPO-AMI-II is 600. We will perform interim analysis twice and the study will stop when superior efficacy or futility is detected by the interim analysis (UMIN-ID 000005721).
Tetsuo Minamino has graduated Osaka University School of Medicine at the age of 24 and completed his Ph.D at the age of 32 years from Osaka University Graduate School of Medicine. He is the associate professor of cardiovascular department, Osaka Graduate School of Medicine. He has published more than 120 papers in reputed journals.