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

Phase 4

Recruiting

• Conditions: Acute Coronary Syndrome; Coronary Stent Implantation
• Interventions: Drug: Ticagrelor 60mg; Drug: Ticagrelor 90mg

• Registration Number: NCT04255602
• Lead Sponsor: Shanghai Tong Ren Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Study Start: 2020-02-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose ticagrelor	Ticagrelor 60mg	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
standard dose ticagrelor	Ticagrelor 90mg	subjects will be treated with ticagrelor 90mg twice daily and aspirin 100mg once daily for a year since drug eluting stent implantation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (8)

shanghai Tongren hospital; 🇨🇳 Shanghai, Shanghai, China

Ningbo 4th hospital; 🇨🇳 Xiangshan, Zhejiang, China

Taishan people's hospital; 🇨🇳 Taishan, Guangdong, China

South East of Shandong hospital; 🇨🇳 Liaocheng, Shandong, China

Songjiang hospital, Shanghai jiaotong university, school of medicine; 🇨🇳 Shanghai, Shanghai, China

Yanzhou branch of affiliated hospital of Jining medical university; 🇨🇳 Jining, China

zhangshan hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Minhang hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China