Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,612
- 主要终点
- Primary Endpoint 1 (composite ischemic events for non-inferiority testing)
研究概览
简要总结
The study aims to optimize the dual antiplatelet therapy regimen for patients with STEMI after PCI, focusing on addressing the following key technical challenges: establishing an effectiveness evaluation system for a low-dose aspirin (50mg/day) antithrombotic treatment strategy based on ticagrelor, including the formulation of a scientific non-inferiority margin, assessment criteria, and composite endpoint determination standards; constructing a strict risk assessment system for major bleeding events, including bleeding event grading based on BARC standards and a blind evaluation process by an independent endpoint event adjudication committee; and developing a quality control system for multicenter clinical research to ensure patient follow-up compliance and data reliability. By solving the above technical challenges, the study provides evidence-based medical support and technical support for optimizing the antithrombotic treatment regimen for STEMI patients after PCI.
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, Investigator)
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
- •STEMI patients with clear diagnosis Has received PCI treatment (at least the culprit's blood vessels have been treated); 18 years old and above, regardless of gender; Received DAPT upon discharge: aspirin+ticagrelor; Signed informed consent form approved by the ethics committee
排除标准
- •Individuals with atrial fibrillation/DVT/valve surgery requiring anticoagulant medication; Combined cardiomyopathy (HCM/DCM/RCM); Combining severe ventricular arrhythmias requires ICD; Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease); Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients; Diseases of the blood system, such as thrombocytopenia, severe anemia, leukemia, etc; Severe liver and kidney dysfunction; Malignant tumors; Cognitive impairment
研究组 & 干预措施
Aspirin 50mg/d
STEMI patients receive aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily
干预措施: aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily (Drug)
Aspirin 100mg/d
STEMI patients receive aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily
干预措施: aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily (Drug)
结局指标
主要结局
Primary Endpoint 1 (composite ischemic events for non-inferiority testing)
时间窗: 12 months
Primary Endpoint 1 (composite ischemic events for non-inferiority testing) includes all-cause death, non-fatal myocardial infarction, non-fatal stroke, and urgent/ischemia-driven target vessel revascularization
Primary Endpoint 2 (bleeding events for superiority testing)
时间窗: 12 months
Secondary endpoints at 12 months include individual components of the composite ischemic endpoint, stent thrombosis, and safety endpoints comprising BARC type 2-5 bleeding events, GUSTO mild, moderate, and severe/life-threatening bleeding, and non-CABG-related minimal, minor, and major bleeding
次要结局
未报告次要终点