A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients

Study Overview
=================
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

Official Title
-----------------
A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome, Coronary Stent Implantation

Intervention / Treatment
-----------------
* Drug: Ticagrelor 60mg
* Drug: Ticagrelor 90mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be at least 18 years of age Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure Exclusion Criteria: Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study Active bleeding Known hypersensitivity or contraindication to study medications 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). Subjects with Cerebral hemorrhage history Subjects with stroke history in half a year subjects with malignant tumor subjects with whom oral anticoagulants are needed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose ticagrelor<br>After treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a week,subjects will be treated with ticagrelor 60mg twice daily and aspirin 100mg once daily for until one year after drug eluting stent implantation | Drug: Ticagrelor 60mg<br>* Ticagrelor 60mg plus Aspirin 100mg for experimental group<br>|
| Active Comparator: standard dose ticagrelor<br>subjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation | Drug: Ticagrelor 90mg<br>* Ticagrelor 90mg plus Aspirin 100mg for active comparator group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2 | 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 | Stent implantation to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding events of BARC grade ≥2 | bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria | Stent implantation to 12 months | 
| a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke | a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke | Stent implantation to 12 months |