A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients
NCT ID: NCT04255602
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2120 participants
INTERVENTIONAL
2020-02-19
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Ticagrelor 60mg
Ticagrelor 60mg plus Aspirin 100mg for experimental group
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
Ticagrelor 90mg
Ticagrelor 90mg plus Aspirin 100mg for active comparator group
Interventions
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Ticagrelor 60mg
Ticagrelor 60mg plus Aspirin 100mg for experimental group
Ticagrelor 90mg
Ticagrelor 90mg plus Aspirin 100mg for active comparator group
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
90 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Fudan University
OTHER
Shanghai Tong Ren Hospital
OTHER
Responsible Party
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Principal Investigators
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Junbo Ge, Doctor
Role: STUDY_CHAIR
Fudan University
Lei Hou, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Tongren Hospital
Locations
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Taishan people's hospital
Taishan, Guangdong, China
South East of Shandong hospital
Liaocheng, Shandong, China
zhangshan hospital, Fudan University
Shanghai, Shanghai Municipality, China
shanghai Tongren hospital
Shanghai, Shanghai Municipality, China
Minhang hospital, Fudan University
Shanghai, Shanghai Municipality, China
Songjiang hospital, Shanghai jiaotong university, school of medicine
Shanghai, Shanghai Municipality, China
Ningbo 4th hospital
Xiangshan, Zhejiang, China
Yanzhou branch of affiliated hospital of Jining medical university
Jining, , China
Countries
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Central Contacts
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Facility Contacts
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yan Chen, Doctor
Role: primary
zhongwei Jia, doctor
Role: primary
Junbo Ge, Doctor
Role: primary
Lei Hou, Doctor
Role: primary
Wei Hu, Doctor
Role: primary
Lei Hou, Dr
Role: primary
jianfei Ye, master
Role: primary
Jian Yang
Role: primary
References
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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.
Other Identifiers
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HP2020125
Identifier Type: -
Identifier Source: org_study_id