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

Acute Coronary Syndrome Clinical Trial

— TIGER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255602
• Other study ID #: HP2020125
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Stent Implantation
• Syndrome

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