A single-center prospective randomized controlled trial evaluating the safety and efficacy of IntraCoronary Erythropoietin delivery BEfore Reperfusion: Gauging infarct size in patients with acute ST-segment elevation myocardial infarction. Study design and rationale of the 'ICEBERG Trial'

作者：Suh Jung Won; Yoon Yeonyee E; Oh Il Young; Yoon Chang Hwan; Cho Young Seok; Youn Tae Jin; Chae In Ho; Choi Dong Ju^*

来源：Contemporary Clinical Trials, 2013, 35(1): 145-150.

DOI：10.1016/j.cct.2013.03.001

• Erythropoietin
• Reperfusion injury
• Acute myocardial infarction

Background: Erythropoietin (EPO) protected the myocardium from ischemia and reperfusion injury in preclinical studies. However, whether EPO can reduce myocardial injury in patients with acute myocardial infarction (MI) is controversial. The inconsistent results of previous studies have been attributed to differences in the doses, timing, and routes of administration of EPO. In this study, we will evaluate intracoronary treatment with a long-acting EPO analog, darbepoetin-alpha, administered immediately before reperfusion in patients with acute anterior ST-segment elevation MI.
Methods: This trial will be a single-center, prospective, randomized, two-arm, controlled trial with blind evaluation of the endpoints. At the time of the primary percutaneous coronary intervention, 80 patients will randomly receive one of the following treatments immediately before the first ballooning: intracoronary darbepoetin-alpha (ARANESP (R); Jeil-Kirin Pharm., Korea) 300 mu g (n = 40) or saline (n = 40), administered via the over-the-wire balloon system. The objectives of this study are to evaluate the safety and efficacy of intracoronary darbepoetin-alpha therapy.
Discussion: This is the first study to evaluate the safety and efficacy of intracoronary darbepoetin-alpha treatment in patients with acute MI.

• 出版日期2013-5