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Risk score-guided dual antiplatelet therapy in Korean acute coronary syndrome patients receiving bioabsorbable-polymer everolimus eluting stent (Synergy stent)

Status Approved

  • First Submitted Date

    2021/01/11

  • Registered Date

    2021/03/16

  • Last Updated Date

    2022/04/28

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006003
    Unique Protocol ID CNUH-2019-355
    Public/Brief Title Risk score-guided dual antiplatelet therapy in Korean acute coronary syndrome patients receiving bioabsorbable-polymer everolimus eluting stent (Synergy stent)
    Scientific Title Risk score-guided dual antiplatelet therapy in Korean acute coronary syndrome patients receiving bioabsorbable-polymer everolimus eluting stent (Synergy stent)
    Acronym SAMIR ll
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH-2019-355
    Approval Date 2020-03-16
    Institutional Review Board Name CHONNAM NATIONAL UNIVERSITY HOSPITAL INSTITUTIONAL REVIEW BOARD
    Institutional Review Board Address 42, Jebong-ro, Dong-gu, Gwangju
    Institutional Review Board Telephone 062-220-5257
    Data Monitoring Committee Yes
    CEAC
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Myungho Jeong
    Title Professor
    Telephone +82-62-220-5272
    Affiliation Chonnam National University Hospital
    Address 42, Jebong-ro, Dong-gu, Gwangju, Republic of Korea
    Contact Person for Public Queries
    Name Hyojin Park
    Title Research Nurse
    Telephone +82-62-220-5272
    Affiliation Chonnam National University Hospital
    Address 42, Jebong-ro, Dong-gu, Gwangju, Republic of Korea
    Contact Person for Updating Information
    Name Hyojin Park
    Title Research Nurse
    Telephone +82-62-220-5272
    Affiliation Chonnam National University Hospital
    Address 42, Jebong-ro, Dong-gu, Gwangju, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 20
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-03-16 Actual
    Target Number of Participant 1000
    Primary Completion Date 2025-03-31 , Anticipated
    Study Completion Date 2025-10-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-03-16 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Gyeongsang National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-07-16 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Wonkwang University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-07-09 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Jeonbuk National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-23 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Kosin University Gospel Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-07-24 ,
    Recruitment Status by Participating Study Site 6
    Name of Study The Catholic University of Korea, Bucheon St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-03-31 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Kyung Hee University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2022-05-01 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-12-01 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Kwangju Christian Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-01-08 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Yeongnam University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2021-01-28 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Pusan National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2022-05-01 ,
    Recruitment Status by Participating Study Site 12
    Name of Study Pusan National University Yangsan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-09-10 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Gyeongsang National University Changwon Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-12-15 ,
    Recruitment Status by Participating Study Site 14
    Name of Study Gwangju Veterans Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-04-07 ,
    Recruitment Status by Participating Study Site 15
    Name of Study Presbyterian Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2020-10-06 ,
    Recruitment Status by Participating Study Site 16
    Name of Study Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2021-02-24 ,
    Recruitment Status by Participating Study Site 17
    Name of Study Kyung Hee University Hospital at Gangdong
    Recruitment Status Recruiting
    Date of First Enrollment 2020-09-07 ,
    Recruitment Status by Participating Study Site 18
    Name of Study Chungbuk National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-07-30 ,
    Recruitment Status by Participating Study Site 19
    Name of Study St. Carollo General Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-07-10 ,
    Recruitment Status by Participating Study Site 20
    Name of Study Kangdong Sacred Heart Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2022-05-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Boston Scientific Korea
    Organization Type Others
    Project ID 지정하고있지 않음
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    In patients with acute coronary syndrome undergoing PCI, DAPT with more potent P2Y12 inhibitors are recommended but at the cost of increased risk of bleeding, especially in East Asians. In the recent study using Korea Acute Myocardial Infarction Registry—National Institute of Health (KAMIR-NIH) database, ticagrelor did not reduce ischemic events yet, however, was associated with increased risk of bleeding complications compared with clopidogrel. And, the recommended dose of prasugrel had significantly higher in-hospital bleeding complications without reducing ischemic events compared with clopidogrel in Korean patients with acute MI. In Korean patients with non-ST elevation MI, potent P2Y12 blockers were associated with reduced ischemic but increased bleeding risk with similar net clinical benefits
    .
    Several bleeding risk prediction tools are proposed for the management of patients receiving DAPT, but no standardized tool exists for the purpose. The recent European guidelines with respect to DAPT recommend that discontinuation of P2Y12 inhibitor after 6 months should be considered in patients with acute coronary syndrome and stent implantations at high risk of bleeding (e.g.  PRECISE-DAPT score). In UK patients undergoing PCI for acute coronary syndrome, a significant reduction in major adverse cardiac events rates between the patients’ risk score stratified and control (clopidogrel therapy) (13.7% vs. 19.7%, p <0.0001) was seen during the 1.8-year follow-up. In Korean patients post-PCI on DAPT, the PRECISE-DAPT score predicted 1 year bleeding significantly better than the ACUITY HORIZONES score with improved reclassification performance. And, 12-month mortality was lower with ticagrelor in Korean patients receiving DES for acute MI with high GRACE score but without very high (≥20) ACUITY-HORIZONS score (2.4% vs. 5.3%, p=0.03).
     The present study aims to assess the usefulness of risk score-guided DAPT in patients with acute MI receiving BP-EES (Synergy stent) from real-world clinical practice in Korea.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 1000
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patient inserting Synergy stent for acute coronary syndrome in Korea

    Cohort/Group Description

    (1) Population information and history : Age, sex, chest condition, diagnosis, risk factor and overabrication, presence of non-invasive testing and results (2) Treatment information : coronary angiography and intervention date, OCT-guided and Angiography-guided status, number of lesions, location and number of stents inserted ; (3) Pre-pre-procedure anticoagulant medication (4) Information on presence and results of non-invasive tests during hospitalization, presence of complications, discharge date of discharge date, and antiangiogenic and accompanying medications when discharged (5) CBC, Electrolyte, Liver function, Creatinine, BUN, Total cholesterol, LDL cholesterol, Based on Visit 1 visit date, it can be substituted with the result of an inspection conducted three months ago to the next day of percutaneous coronary artery surgery. Post-procedure blood testing is not mandatory, but clinically indicated. (6) Observation of 1 month, 6 months and 1 year of follow-up : date of visit, presence of major heart event, presence of re-investigation, infectivity, and accompanying medication information (7) Tracking coronary tree information (when conducted during the follow-up period)
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patient who undergo percutaneous coronary intervention with Synergy stent for acute coronary syndrome
    Sampling Method
    Non-probablity sampling :  We will enroll the patients non-consecutively at about 20 centers in Korea
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I21.9)Acute myocardial infarction, unspecified 

    Patients diagnosed with acute myocardial infarction or unstable angina
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    -Patients ≥ 19 years old 
    -Patients with acute coronary syndrome having lesions requiring interventions amendable for implantation of Synergy during the index procedure
    -Patients who voluntarily decide to participate in this research and agree to the consent form
    Exclusion Criteria
    -Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study
    - If the life expectancy is less than three years 
    -Patients requiring oral anticoagulation
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Net adverse clinical events defined as a composite of all-cause death, myocardial infarction, repeat percutaneous coronary intervention or coronary artery bypass graft surgery, stent thrombosis, stroke, and major/minor bleeding [BARC type 3-5/1-2]
    Timepoint
    at 1 and 3 years
    Secondary Outcome(s) 1
    Outcome
    Major adverse cardiac and cerebrovascular events defined as a composite of all-cause death, myocardial infarction, repeat percutaneous coronary intervention or coronary artery bypass graft surgery, stent thrombosis, and stroke
    Timepoint
    at 1 and 3 years
    Secondary Outcome(s) 2
    Outcome
    All-cause death
    Timepoint
    at 1 and 3 years
    Secondary Outcome(s) 3
    Outcome
    Myocardial infarction
    Timepoint
    at 1 and 3 years
    Secondary Outcome(s) 4
    Outcome
    Repeat percutaneous coronary intervention or coronary artery bypass graft surgery
    Timepoint
    at 1 and 3 years
    Secondary Outcome(s) 5
    Outcome
    Stent thrombosis
    Timepoint
    at 1 and 3 years
    Secondary Outcome(s) 6
    Outcome
    Stroke
    Timepoint
    at 1 and 3 years
    Secondary Outcome(s) 7
    Outcome
    Major or minor bleeding [BARC type 3-5/1-2]
    Timepoint
    at 1 and 3 years
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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