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

Sponsor

Shanghai Tong Ren Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04255602

Collaborator

Shanghai Jiao Tong University School of Medicine (Other), Fudan University (Other)

2,120

Enrollment

Locations

Arms

34.4

Anticipated Duration (Months)

302.9

Patients Per Site

8.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Coronary Stent Implantation	Drug: Ticagrelor 60mg Drug: Ticagrelor 90mg	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 19, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low dose ticagrelor 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 Ticagrelor 60mg plus Aspirin 100mg for experimental group
Active Comparator: standard dose ticagrelor 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 Ticagrelor 90mg plus Aspirin 100mg for active comparator group

Arm

Intervention/Treatment

Experimental: low dose ticagrelor

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

Ticagrelor 60mg plus Aspirin 100mg for experimental group

Active Comparator: standard dose ticagrelor

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

Ticagrelor 90mg plus Aspirin 100mg for active comparator group

Outcome Measures

Primary Outcome Measures

a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2 [Stent implantation to 12 months]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taishan people's hospital	Taishan	Guangdong	China	529200
2	South East of Shandong hospital	Liaocheng	Shandong	China
3	zhangshan hospital, Fudan University	Shanghai	Shanghai	China	200032
4	shanghai Tongren hospital	Shanghai	Shanghai	China	200050
5	Minhang hospital, Fudan University	Shanghai	Shanghai	China	201100
6	Ningbo 4th hospital	Xiangshan	Zhejiang	China
7	Yanzhou branch of affiliated hospital of Jining medical university	Jining		China

Sponsors and Collaborators

Shanghai Tong Ren Hospital
Shanghai Jiao Tong University School of Medicine
Fudan University

Investigators

Study Chair: Junbo Ge, Doctor, Fudan University
Principal Investigator: Lei Hou, Doctor, Shanghai Tongren hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Tong Ren Hospital

ClinicalTrials.gov Identifier:

NCT04255602

Other Study ID Numbers:

HP2020125

First Posted:

Feb 5, 2020

Last Update Posted:

Apr 1, 2022

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Ticagrelor

Study Results

No Results Posted as of Apr 1, 2022