Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction: A Prospective, Multicenter, Pragmatic Randomized Controlled Real-World Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 9,588
- 试验地点
- 1
- 主要终点
- Incidence of major adverse cardiovascular and cerebrovascular events (MACE)
研究概览
简要总结
This study aims to evaluate the value of Shexiang Baoxin Pill (MUSKARDIA) in patients with acute myocardial infarction (AMI) through a prospective, multicenter, pragmatic randomized controlled real-world study. It seeks to validate its efficacy in reducing cardiovascular event risk during the peri-PCI period, as well as its effects on cardiac function, quality of life , and relevant biomarkers. Through this research, we expect to provide higher-quality evidence for the application of SBP in AMI patients undergoing PCI, thereby further optimizing comprehensive treatment strategies for AMI.
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
- •Aged 18 years or older, regardless of gender
- •In accordance with the 2023 ESC Guidelines for the Management of Acute Coronary Syndromes , meeting the diagnostic criteria for acute myocardial infarction, including typical chest pain lasting for ≥20 minutes, electrocardiographic manifestations of ST-segment elevation (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), and serum high-sensitivity troponin (hs-cTn) levels exceeding the 99th percentile of the upper reference limit at least once with dynamic changes
- •Presenting for treatment within <24 hours of symptom onset and scheduled to undergo PCI
- •The patient or their guardian has signed the informed consent form
排除标准
- •Having contraindications to PCI treatment
- •Being allergic to Shexiang Baoxin Pills, unable to tolerate them, or having other conditions that prevent completion of the trial drug administration
- •Being pregnant, planning to become pregnant, or breastfeeding women
- •Having participated in other clinical studies within 3 months
- •Being deemed unsuitable for inclusion in this study by the researcher
研究组 & 干预措施
the Shexiang Baoxin Pill Group
Patients in the Shexiang Baoxin Pill group initiated treatment immediately after randomization. They received 2-4 pills of Shexiang Baoxin Pill preoperatively before PCI, followed by a maintenance dose of 2-4 pills orally three times daily (TID) with warm water for 12 months postoperatively, concurrently with standard guideline-directed therapy.
干预措施: Shexiang Baoxin Pill (Drug)
the Conventional Treatment Group
Patients in the conventional treatment group will receive standard treatment in accordance with guidelines and consensuses after surgery, and this will last for 12 months.
干预措施: Aspirin (Drug)
结局指标
主要结局
Incidence of major adverse cardiovascular and cerebrovascular events (MACE)
时间窗: 1 year after PCI
Cumulative incidence of MACE events at 1 year from the start of randomization. MACE events include cardiac death, non-fatal myocardial infarction, non-fatal stroke, re-hospitalization for angina pectoris, and unplanned revascularization.
次要结局
- Incidence of non-fatal myocardial infarction(1 year after PCI)
- Incidence of non-fatal stroke(1 year after PCI)
- Rehospitalization rate due to angina pectoris(1 year after PCI)
- Rate of unplanned revascularization(1 year after PCI)
- Cardiac mortality rate(1 year after PCI)
- Rehospitalization rate due to heart failure(1 year after PCI)
- All-cause mortality rate(1 year after PCI)
- Seattle Angina Questionnaire score(1 year after PCI)
- EQ-5D-5L scale(1 year after PCI)