A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow During Primary PCI for the Acute Myocardial InfartiON
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
研究概览
简要总结
The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-segment elevation AMI within 12 hours of symptom onset
排除标准
- •Contraindications to thrombolysis or PCI
- •Patients administered a fibrinolytic agent before PCI
- •Patients enrolled in clinical trials
研究组 & 干预措施
Prourokinase
Intracoronary bolus infusion of 20mg prourokinase using selective catheter
干预措施: Prourokinase (Drug)
Tirofiban
Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg)
干预措施: Tirofiban (Drug)
Normal saline
Intracoronary saline bolus infusion using selective catheter (20ml)
干预措施: normal saline (Drug)
结局指标
主要结局
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
时间窗: At the end of Percutaneous Coronary Intervention procedure
次要结局
- incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization(30 days post PCI)
- infarction area confirmed by SPECT(30 days post PCI)
- ST segment resolution in ECG(3 hours post PCI procedure)
- peak troponin T level(in the 7 days post PCI procedure)
- plasma N terminal-proBNP levels(1 and 30 days post PCI procedure)
研究者
Ge Junbo
Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital
Fudan University