Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- incidence of ST-segment resolution >70%
研究概览
简要总结
The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
详细描述
The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, however, still a high incidence of impaired post-procedural myocardial perfusion, which is associated with poorer clinical outcomes. Intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an important role in the treatment of patients with STEMI. With higher local drug concentrations, abciximab may have additional anti-platelet, anti-thrombotic and anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC) administration of abciximab. Recent small- to medium-scaled studies have suggested that IC administration of abciximab instead of the (IV) route is associated with improved post-procedural myocardial perfusion and a clinically relevant reduction of major adverse cardiac events.
Because of the limited number of patients included in these studies, a larger randomized clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI. Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab has not been investigated.
Therefore, the investigators intend to evaluate the effect of IC bolus administration of abciximab compared to IV bolus administration on post-procedural myocardial perfusion as assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing primary PCI. The study is a single-center, prospective, randomized trial with blinded evaluation of endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of STEMI defined by
- •chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
- •time from onset of symptoms of less than 12 hours
- •ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
排除标准
- •rescue PCI after thrombolytic therapy
- •need for emergency coronary artery bypass grafting
- •presence of cardiogenic shock
- •known existence of a life-threatening disease with a life expectancy of less than 6 months
- •inability to provide informed consent
- •contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins)
研究组 & 干预措施
intracoronary abciximab
intracoronary administration of abciximab (0.25 mg/kg body weight)
干预措施: abciximab (Drug)
intravenous abciximab
intravenous administration of abciximab (0.25 mg/kg body weight)
干预措施: abciximab (Drug)
结局指标
主要结局
incidence of ST-segment resolution >70%
时间窗: 30 to 60 minutes post-PCI
次要结局
- Bleeding complications(in-hospital)
- Thrombolysis In Myocardial Infarction (TIMI) flow(post-PCI)
- Myocardial Blush Grade (MBG)(post-PCI)
- Incidence of distal embolization(post-PCI)
- persistent residual ST-segment deviation(30 to 60 minutes post-PCI)
- enzymatic infarct size(in-hospital)
- Major Adverse Cardiac Events (MACE)(30 days)