A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients
TIGER
A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome
1 other identifier
interventional
2,120
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2020
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 7, 2023
October 1, 2023
4.9 years
January 29, 2020
December 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
bleeding events of BARC grade ≥2
Stent implantation to 12 months
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke
Stent implantation to 12 months
Study Arms (2)
low dose ticagrelor
EXPERIMENTALAfter 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
standard dose ticagrelor
ACTIVE COMPARATORsubjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation
Interventions
Ticagrelor 90mg plus Aspirin 100mg for active comparator group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Tong Ren Hospitallead
- Shanghai Jiao Tong University School of Medicinecollaborator
- Fudan Universitycollaborator
Study Sites (8)
Taishan people's hospital
Taishan, Guangdong, 529200, China
South East of Shandong hospital
Liaocheng, Shandong, China
zhangshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
shanghai Tongren hospital
Shanghai, Shanghai Municipality, 200050, China
Minhang hospital, Fudan University
Shanghai, Shanghai Municipality, 201100, China
Songjiang hospital, Shanghai jiaotong university, school of medicine
Shanghai, Shanghai Municipality, China
Ningbo 4th hospital
Xiangshan, Zhejiang, China
Yanzhou branch of affiliated hospital of Jining medical university
Jining, China
Related Publications (1)
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.
PMID: 35248132DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Junbo Ge, Doctor
Fudan University
- PRINCIPAL INVESTIGATOR
Lei Hou, Doctor
Shanghai Tongren Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2020
First Posted
February 5, 2020
Study Start
February 19, 2020
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
December 7, 2023
Record last verified: 2023-10