Department of Internal Medicine, Seoul National University College of Medicine, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, South Korea.
Contemp Clin Trials. 2013 May;35(1):145-50. doi: 10.1016/j.cct.2013.03.001. Epub 2013 Mar 16.
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-α, administered immediately before reperfusion in patients with acute anterior ST-segment elevation MI.
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-α (ARANESP®; Jeil-Kirin Pharm., Korea) 300μg (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-α therapy.
This is the first study to evaluate the safety and efficacy of intracoronary darbepoetin-α treatment in patients with acute MI.
在临床前研究中，促红细胞生成素（EPO）可保护心肌免受缺血再灌注损伤。然而，EPO 是否可以减轻急性心肌梗死（MI）患者的心肌损伤仍存在争议。先前研究结果的不一致归因于 EPO 的剂量、时机和给药途径的差异。在本研究中，我们将评估在急性前壁 ST 段抬高型心肌梗死患者再灌注前即刻给予长效 EPO 类似物达贝泊汀-α的经皮冠状动脉内治疗。
这是一项单中心、前瞻性、随机、两臂、对照试验，终点评估为盲法。在首次球囊扩张时，80 例患者将随机接受以下治疗之一：即刻经皮冠状动脉内给予 300μg 达贝泊汀-α（ARANESP®；韩国 Jeil-Kirin Pharm.）（n=40）或生理盐水（n=40），通过经导丝的球囊系统给药。本研究的目的是评估经皮冠状动脉内给予达贝泊汀-α治疗的安全性和疗效。
这是第一项评估急性 MI 患者经皮冠状动脉内给予达贝泊汀-α治疗的安全性和疗效的研究。
