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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 4

Conditions: Coronary Stent Implantation; Acute Coronary Syndrome

Treatments: Drug: Ticagrelor 90mg; Drug: Ticagrelor 60mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04255602

HP2020125

Details and patient eligibility

About

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

Enrollment: 2,120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,120 participants in 2 patient groups

low dose ticagrelor

Experimental group

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

Treatment:

Drug: Ticagrelor 60mg

standard dose ticagrelor

Active Comparator group

Description:

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

Treatment:

Drug: Ticagrelor 90mg