Clinical trial NCT04255602: A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients
Official title: A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Coronary Stent Implantation
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
name: Fudan University
First posted: 2020-02-05
Enrollment: 2120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2
timeFrame: Stent implantation to 12 months
Secondary outcomes:
measure: bleeding events of BARC grade ≥2
timeFrame: Stent implantation to 12 months
measure: a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke
timeFrame: Stent implantation to 12 months
Other outcomes:
Locations:
city: Taishan
country: China
facility: Taishan people's hospital
state: Guangdong
city: Liaocheng
country: China
facility: South East of Shandong hospital
state: Shandong
city: Shanghai
country: China
facility: zhangshan hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: shanghai Tongren hospital
state: Shanghai
city: Shanghai
country: China
facility: Minhang hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Songjiang hospital, Shanghai jiaotong university, school of medicine
state: Shanghai
city: Xiangshan
country: China
facility: Ningbo 4th hospital
state: Zhejiang
city: Jining
country: China
facility: Yanzhou branch of affiliated hospital of Jining medical university
Study officials:
affiliation: Fudan University
name: Junbo Ge, Doctor
role: STUDY_CHAIR
affiliation: Shanghai Tongren Hospital
name: Lei Hou, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pang Y, Ma M, Xia J, Wang D, YanChen, Ye J, Jia Z, Wu S, Yang J, Hou L. A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY. Trials. 2022 Mar 5;23(1):203. doi: 10.1186/s13063-022-06124-z.