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
CRIS Registration Number |
KCT0006003 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 20 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Boston Scientific Korea |
Organization Type | Others |
Project ID | 지정하고있지 않음 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
Study Population Description | Patient who undergo percutaneous coronary intervention with Synergy stent for acute coronary syndrome |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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