Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Death, Mayocardial infarction, NYHA Ⅳ heart failure
研究概览
简要总结
This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.
详细描述
This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty. Patients with STEMI will be randomized into the cocktail group or the control group. Patients in the cocktail group will receive cocktail injection combined with thrombus aspiration. Patients in the control group will receive thrombus aspiration alone. The primary outcome of the cocktail I study is the composite of death, myocardial infarction or class IV heart failure within 1 year. The secondary outcome of the cocktail I study include slow reflow/no reflow during PCI, left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset
排除标准
- •Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT
研究组 & 干预措施
Cocktail with thrombus aspiration
Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration
干预措施: cocktail (Drug)
Cocktail with thrombus aspiration
Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration
干预措施: thrombus aspiration (Device)
Thrombus aspiration
Thrombus aspiration alone
干预措施: thrombus aspiration (Device)
结局指标
主要结局
Death, Mayocardial infarction, NYHA Ⅳ heart failure
时间窗: 1 year
number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure
次要结局
- Left ventricular function(1 year)
- Canadian Cardiovascular Society (CCS) Functional Angina classification(1 year)
- Seattle Angina Questionnaire scores(1 year)
- 6-minute walk distance (6MWD)(1 year)
- Stroke(1 year)
- Slow reflow/no reflow(intraoperative)
研究者
sunddong
Principal Investigator
Xijing Hospital