About this trial
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
Able and willing to provide informed consent and participate in 12 months follow-up period
Able to receive DAPT treatment
Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the
Disqualifiers
Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative <55 years old or in first-degree female relative <65 years old)
Repeated myocardial infarction
Positive serum cardiac troponin I/T
Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
Trial design
Parallel
Treatments tested in this trial
Aspirin
DrugComparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Ticagrelor
DrugComparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
Treatment groups
Trial outcomes
Primary outcomes
Major adverse cardiac and cerebral events (MACCEs)
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
Secondary outcomes
Bleeding episode (Key secondary endpoint)
Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2)
Platelet function
Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)
Medication adherence
Bleeding-related withdrawal
Sponsors and contacts
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