Acute Coronary Syndrome, Coronary Stent Implantation
Conditions
Brief summary
This study is to evaluate the safety and efficacy of 60mg ticagrelor plus 100mg Aspirin to prevent major adverse cardiovascular and cerebrovascular events in one years after drug-eluting stents implantation for Chinese ACS patients compared with 90mg ticagrelor plus 100mg Aspirin
Interventions
DRUGTicagrelor 60mg
Ticagrelor 60mg plus Aspirin 100mg for experimental group
DRUGTicagrelor 90mg
Ticagrelor 90mg plus Aspirin 100mg for active comparator group
Sponsors
Shanghai Jiao Tong University School of Medicine
Fudan University
Shanghai Tong Ren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must be at least 18 years of age 2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Exclusion criteria
1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study 2. Active bleeding 3. Known hypersensitivity or contraindication to study medications 4. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment). 5. Subjects with Cerebral hemorrhage history 6. Subjects with stroke history in half a year 7. subjects with malignant tumor 8. subjects with whom oral anticoagulants are needed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2 | Stent implantation to 12 months | a composite of death from coronary vascular causes,non-fatal myocardial infarction,stent thrombosis,coronary revascularization, stroke and bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bleeding events of BARC grade ≥2 | Stent implantation to 12 months | bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria |
| a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke | Stent implantation to 12 months | a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke |
Countries
China
Contacts
Primary ContactLei Hou, Doctor
Backup ContactJunbo Ge, Doctor
Outcome results
None listed