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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04255602
Other study ID # HP2020125
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 19, 2020
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Shanghai Tong Ren Hospital
Contact Lei Hou, Doctor
Phone 13564868096
Email Dr_houlei@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 2120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Intervention

Drug:
Ticagrelor 60mg
Ticagrelor 60mg plus Aspirin 100mg for experimental group
Ticagrelor 90mg
Ticagrelor 90mg plus Aspirin 100mg for active comparator group

Locations

Country Name City State
China Yanzhou branch of affiliated hospital of Jining medical university Jining
China South East of Shandong hospital Liaocheng Shandong
China Minhang hospital, Fudan University Shanghai Shanghai
China shanghai Tongren hospital Shanghai Shanghai
China Songjiang hospital, Shanghai jiaotong university, school of medicine Shanghai Shanghai
China zhangshan hospital, Fudan University Shanghai Shanghai
China Taishan people's hospital Taishan Guangdong
China Ningbo 4th hospital Xiangshan Zhejiang

Sponsors (3)

Lead Sponsor Collaborator
Shanghai Tong Ren Hospital Fudan University, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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