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

NCT ID: NCT04255602

Last Updated: 2023-12-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-19

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome Coronary Stent Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Ticagrelor 60mg

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Ticagrelor 90mg

Intervention Type DRUG

Ticagrelor 90mg plus Aspirin 100mg for active comparator group

Interventions

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Ticagrelor 60mg

Ticagrelor 60mg plus Aspirin 100mg for experimental group

Intervention Type DRUG

Ticagrelor 90mg

Ticagrelor 90mg plus Aspirin 100mg for active comparator group

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Shanghai Tong Ren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

South East of Shandong hospital

Liaocheng, Shandong, China

Site Status RECRUITING

zhangshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

shanghai Tongren hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Minhang hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Songjiang hospital, Shanghai jiaotong university, school of medicine

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Ningbo 4th hospital

Xiangshan, Zhejiang, China

Site Status RECRUITING

Yanzhou branch of affiliated hospital of Jining medical university

Jining, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Lei Hou, Doctor

Role: CONTACT

Phone: 13564868096

Email: [email protected]

Junbo Ge, Doctor

Role: CONTACT

Email: [email protected]

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.

Reference Type DERIVED
PMID: 35248132 (View on PubMed)

Other Identifiers

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HP2020125

Identifier Type: -

Identifier Source: org_study_id