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

December 6, 2023 updated by: Shanghai Tong Ren Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Jining, China
        • Not yet recruiting
        • Yanzhou branch of affiliated hospital of Jining medical university
        • Contact:
          • jian Yang
    • Guangdong
      • Taishan, Guangdong, China, 529200
        • Recruiting
        • Taishan people's hospital
        • Contact:
          • yan Chen, Doctor
        • Principal Investigator:
          • yan chen, Doctor
    • Shandong
      • Liaocheng, Shandong, China
        • Recruiting
        • South East of Shandong hospital
        • Contact:
          • zhongwei Jia, doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200050
        • Recruiting
        • Shanghai Tongren Hospital
        • Principal Investigator:
          • Caohui Qiu, Doctor
        • Sub-Investigator:
          • Yanan Peng, Doctor
        • Contact:
          • lei hou, doctor
        • Principal Investigator:
          • Lei Hou, doctor
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • zhangshan hospital, Fudan University
        • Contact:
          • Junbo Ge, Doctor
        • Principal Investigator:
          • Junbo Ge, Doctor
      • Shanghai, Shanghai, China, 201100
        • Not yet recruiting
        • Minhang hospital, Fudan University
        • Contact:
          • Wei Hu, Doctor
        • Principal Investigator:
          • Wei Hu, Doctor
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Songjiang hospital, Shanghai jiaotong University, School of medicine
        • Contact:
          • Lei Hou, Dr
    • Zhejiang
      • Xiangshan, Zhejiang, China
        • Recruiting
        • Ningbo 4th hospital
        • Contact:
          • jianfei Ye, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis,coronary revascularization,stroke, and bleeding events of BARC grade ≥2
Time Frame: 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
Stent implantation to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Tong Ren Hospital

Collaborators

Fudan University
Shanghai Jiao Tong University School of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP2020125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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