Department of Cardiology, Thorax Center, University Medical Center Groningen, University of Groningen, Hanzeplein 1 PO Box 30001, 9700 RB Groningen, the Netherlands.
Trials. 2009 Sep 28;10:90. doi: 10.1186/1745-6215-10-90.
Administration of abciximab during primary percutaneous coronary intervention is an effective adjunctive therapy in the treatment of patients with ST-segment elevation myocardial infarction. Recent small-scaled studies have suggested that intracoronary administration of abciximab during primary percutaneous coronary intervention is superior to conventional intravenous administration. This study has been designed to investigate whether intracoronary bolus administration of abciximab is more effective than intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with thrombus aspiration.
METHODS/DESIGN: The Comparison of IntraCoronary versus intravenous abciximab administration during Emergency Reperfusion Of ST-segment elevation myocardial infarction (CICERO) trial is a single-center, prospective, randomized open-label trial with blinded evaluation of endpoints. A total of 530 patients with STEMI undergoing primary percutaneous coronary intervention are randomly assigned to either an intracoronary or intravenous bolus of weight-adjusted abciximab. The primary end point is the incidence of >70% ST-segment elevation resolution. Secondary end points consist of post-procedural residual ST-segment deviation, myocardial blush grade, distal embolization, enzymatic infarct size, in-hospital bleeding, and clinical outcome at 30 days and 1 year.
The CICERO trial is the first clinical trial to date to verify the effect of intracoronary versus intravenous administration of abciximab on myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with thrombus aspiration.
在直接经皮冠状动脉介入治疗中应用阿昔单抗是治疗 ST 段抬高型心肌梗死患者的一种有效辅助治疗方法。最近的小规模研究表明，在直接经皮冠状动脉介入治疗中冠状动脉内给予阿昔单抗优于常规静脉内给予。本研究旨在探讨在血栓抽吸的直接经皮冠状动脉介入治疗中，与常规静脉推注相比，冠状动脉内推注阿昔单抗是否能更有效地改善 ST 段抬高型心肌梗死患者的心肌灌注。
方法/设计：比较直接经皮冠状动脉介入治疗中冠状动脉内与静脉内给予阿昔单抗对 ST 段抬高型心肌梗死患者再灌注的效果（CICERO）试验是一项单中心、前瞻性、随机、开放标签、终点盲法评估试验。共纳入 530 例接受直接经皮冠状动脉介入治疗的 STEMI 患者，随机分为冠状动脉内或静脉内推注体重调整剂量的阿昔单抗。主要终点是 ST 段抬高缓解率>70%。次要终点包括术后残余 ST 段偏移、心肌灌注分级、远端栓塞、酶学梗死面积、院内出血以及 30 天和 1 年的临床转归。
CICERO 试验是迄今为止首个验证在血栓抽吸的直接经皮冠状动脉介入治疗中，与静脉内给予阿昔单抗相比，冠状动脉内给予阿昔单抗对 ST 段抬高型心肌梗死患者心肌灌注影响的临床试验。
