Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 198
- 主要终点
- Change from baseline myocardial infarct size at 6 months
研究概览
简要总结
Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
- •Between the ages of 18-75;
- •Volunteer to participate in this study and have signed an informed consent form;
- •Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation.
排除标准
- •Not suitable for coronary intervention;
- •With unstable hemodynamics;
- •Platelet count<100×109;
- •Suspected aortic dissection or acute pulmonary embolism;
- •With mechanical complications;
- •With uncontrolled acute left heart failure and pulmonary edema;
- •With known bleeding history, active bleeding, bleeding constitution, or severe hemostatic and coagulation dysfunction;
- •Meantain anticoagulants (such as warfarin or new anticoagulants);
- •Severe liver and kidney insufficiency (Child-Pugh B and above, Cr>177μmol/L (2mg/dl) or eGFR<45ml/min/1.73m2);
- •CTO, stent stenosis, or severe left main disease;
- •History of coronary artery bypass graft surgery;
- •Other pathophysiological conditions whose expected survival period is less than 1 year;
- •Allergic history to Suxiao Jiuxin Pills;
- •Pregnant or lactating women;
- •Participating in other clinical studies;
- •With other diseases that are not suitable for participating in clinical research.
研究组 & 干预措施
Suxiao Jiuxin Pills
Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days
干预措施: Suxiao Jiuxin Pills (Drug)
The placebo of Suxiao Jiuxin Pills
The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days
干预措施: The placebo of Suxiao Jiuxin Pills (Drug)
结局指标
主要结局
Change from baseline myocardial infarct size at 6 months
时间窗: 3-5 days after PCI and 180±7 days
MI size measure by CMR
Change from baseline incidence of microvascular obstruction at 6 months
时间窗: 3-5 days after PCI and 180±7 days
Incidence of Microvascular obstruction measure by CMR
次要结局
- Change from baseline incidence of area-at-risk at 6 months(3-5 days after PCI and 180±7 days)
- Change from baseline incidence of intramyocardial hemorrhagex at 6 months(3-5 days after PCI and 180±7 days)
- Quantitative flow ratio(During the procedure)
- Change of CK-MB(Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days)
- Change of ST segment in electrocardiogram(Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days)
- Change of cTnI(Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days)
- Change of NT-proBNP(Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days)
- Change of ejection fraction in echocardiography(Baseline, 3-5 days after PCI and 180±7 days)
- Change of 6 Minute Walk Test(3-5 days after PCI, 30±7 days and 180±7 days)
- Incidence of MACCE(Through study completion, an average of 1 year)
- Incidence of complications of PCI(Up to 1 month)
- Incidence of bleeding event(Up to 6 months)
- Incidence of stent restenosis(180±7 days)
- Incidence of death event(Through study completion, an average of 1 year)
- Change of Seattle Angina Questionnaire (SAQ)(baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days)