About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily
DrugSTEMI patients receive aspirin 50 mg once daily (one 50 mg aspirin tablet plus one matching placebo tablet) plus ticagrelor 90 mg twice daily
aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily
DrugSTEMI patients receive aspirin 100 mg once daily (two 50 mg aspirin tablets) plus ticagrelor 90 mg twice daily
Treatment groups
Trial outcomes
Primary outcomes
Primary Endpoint 1 (composite ischemic events for non-inferiority testing)
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)
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
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: