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

Primary Purpose

Acute Coronary Syndrome, Coronary Stent Implantation

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor 60mg
Ticagrelor 90mg
Sponsored by
Shanghai Tong Ren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taishan people's hospitalRecruiting
  • South East of Shandong hospitalRecruiting
  • zhangshan hospital, Fudan University
  • shanghai Tongren hospitalRecruiting
  • Minhang hospital, Fudan University
  • Songjiang hospital, Shanghai jiaotong university, school of medicine
  • Ningbo 4th hospitalRecruiting
  • Yanzhou branch of affiliated hospital of Jining medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low dose ticagrelor

standard dose ticagrelor

Arm Description

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

subjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

bleeding events of BARC grade ≥2
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
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke

Full Information

First Posted
January 29, 2020
Last Updated
March 5, 2023
Sponsor
Shanghai Tong Ren Hospital
Collaborators
Shanghai Jiao Tong University School of Medicine, Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04255602
Brief Title
A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients
Acronym
TIGER
Official Title
A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Tong Ren Hospital
Collaborators
Shanghai Jiao Tong University School of Medicine, Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Coronary Stent Implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low dose ticagrelor
Arm Type
Experimental
Arm Description
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
Arm Title
standard dose ticagrelor
Arm Type
Active Comparator
Arm Description
subjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 60mg
Intervention Description
Ticagrelor 60mg plus Aspirin 100mg for experimental group
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 90mg
Intervention Description
Ticagrelor 90mg plus Aspirin 100mg for active comparator group
Primary Outcome Measure Information:
Title
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2
Description
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
Time Frame
Stent implantation to 12 months
Secondary Outcome Measure Information:
Title
bleeding events of BARC grade ≥2
Description
bleeding type 2, 3 or 5 according to the Bleeding Academic Research Consortium (BARC) criteria
Time Frame
Stent implantation to 12 months
Title
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke
Description
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke
Time Frame
Stent implantation to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Hou, Doctor
Phone
13564868096
Email
Dr_houlei@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junbo Ge, Doctor
Email
Ge.junbo@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, Doctor
Organizational Affiliation
Fudan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lei Hou, Doctor
Organizational Affiliation
Shanghai Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taishan people's hospital
City
Taishan
State/Province
Guangdong
ZIP/Postal Code
529200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yan Chen, Doctor
First Name & Middle Initial & Last Name & Degree
yan chen, Doctor
Facility Name
South East of Shandong hospital
City
Liaocheng
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhongwei Jia, doctor
Facility Name
zhangshan hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, Doctor
First Name & Middle Initial & Last Name & Degree
Junbo Ge, Doctor
Facility Name
shanghai Tongren hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Hou, Doctor
First Name & Middle Initial & Last Name & Degree
Lei Hou, Doctor
First Name & Middle Initial & Last Name & Degree
Caohui Qiu, Doctor
First Name & Middle Initial & Last Name & Degree
Yanan Peng, Doctor
Facility Name
Minhang hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Hu, Doctor
First Name & Middle Initial & Last Name & Degree
Wei Hu, Doctor
Facility Name
Songjiang hospital, Shanghai jiaotong university, school of medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Hou, Dr
Facility Name
Ningbo 4th hospital
City
Xiangshan
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianfei Ye, master
Facility Name
Yanzhou branch of affiliated hospital of Jining medical university
City
Jining
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Yang

12. IPD Sharing Statement

Citations:
PubMed Identifier
35248132
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.
Results Reference
derived

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

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