Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial
- Conditions
- ST-elevation Myocardial Infarction (STEMI)
- Interventions
- Registration Number
- NCT06756945
- Lead Sponsor
- Beijing Anzhen Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 3612
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin 50mg/d aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily STEMI patients receive aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily Aspirin 100mg/d aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily STEMI patients receive aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily
- Primary Outcome Measures
Name Time Method Primary Endpoint 1 (composite ischemic events for non-inferiority testing) 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) 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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