Status Approved
First Submitted Date
2018/08/21
Registered Date
2019/01/16
Last Updated Date
2022/11/01
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003431 |
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Unique Protocol ID | GCIRB 2016-324 |
Public/Brief Title | The effects of combination of moderate-intensity statin and ezetimibe compared to high-intensity statin alone on coronary plaque regression in patients with percutaneous coronary intervention |
Scientific Title | The effects of combination of moderate-intensity statin and ezetimibe compared to high-intensity statin alone on coronary plaque regression in patients with percutaneous coronary intervention |
Acronym | ATOZET study |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted approval |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | GCIRB 2016-324 |
Approval Date | 2016-11-17 |
Institutional Review Board Name | Gachon University Gil Medical Center IRB |
Institutional Review Board Address | 21, Namdong-daero 774beon-gil, Namdong-gu, Incheon |
Institutional Review Board Telephone | 032-460-2092 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Kang Woong chol |
Title | Professor |
Telephone | +82-32-460-3054 |
Affiliation | Gachon University Gil Medical Center |
Address | 21, 774 Namdongdaero, Namdon-Gu Incheon |
Contact Person for Public Queries | |
Name | Kang Woong chol |
Title | Professor |
Telephone | +82-32-460-3054 |
Affiliation | Gachon University Gil Medical Center |
Address | 21, 774 Namdongdaero, Namdon-Gu Incheon |
Contact Person for Updating Information | |
Name | Kang Woong chol |
Title | Professor |
Telephone | +82-32-460-3054 |
Affiliation | Gachon University Gil Medical Center |
Address | 21, 774 Namdongdaero, Namdon-Gu Incheon |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2017-03-29 Actual | |
Target Number of Participant | 24 | |
Primary Completion Date | 2018-12-31 , Actual | |
Study Completion Date | 2020-06-25 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Gachon University Gil Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2017-03-29 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Chong Kun Dang |
Organization Type | Pharmaceutical Company |
Project ID | GCIRB 2016-324 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Gachon University Gil Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Hypercholesterolemia is one of the major risk factors for cardiovascular disease. Treatment with statins to lower cholesterol is important for the secondary prevention of cardiovascular disease. In addition to the effect of reducing cholesterol synthesis and decreasing low-density lipoprotein-cholesterol (LDL-C), It has been known that statins has several pleotropic effects including anti-inflammatory effect, antithrombotic effect, and improvement of endothelial function. It has been proven to reduce the atherosclerotic lesion and inhibit the progression. Therefore, the ACC/AHA guidelines recommend high-intensity statins for coronary artery disease and the ESC recommends a reduction of LDL-C of less than 70 mg / dL or more than 50% of baseline. However, long-term use of high-intensity statins increases the incidence of diabetes mellitus, liver damage, and musculoskeletal injuries. Therefore, there are many concerns about the use of high-intensity statins, especially in elderly patients. There is a lack of information about side effects. Ezetimibe reduces serum cholesterol level by inhibiting its absorption in the small intestine. It reduces LDL-C by 15-25% when used in combination with statins. In a recently published study of patients with acute coronary syndrome (IMPROVE-IT), the combination of simvastatin and ezetimibe significantly reduced LDL-C levels compared to simvastatin alone. In addition, the combination of atorvastatin and ezetimibe showed a significant reduction of LDL-C and coronary atherosclerosis compared to statin alone in the study of coronary intravascular ultrasonography. To date, studies have shown that LDL-C is additionally reduced when ezetimibe is combined with statin, which has beneficial effects such as prevention of cardiovascular events and reduction of atherosclerotic plaques. However, when LDL-C is reduced to similar levels using high-intensity statins, it is unclear whether statin and ezetimibe combination treatments will have similar effects to high-intensity statins. This study investigates whether the combination of statin and ezetimibe shows similar results compared with high-intensity statins, indicating that this combination therapy may be an effective alternative in patients with high-intensity statins. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase4 |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | This clinical trial was designed with a single organ, random assignment, comparator comparison, parallel design, and open study. For patients who have performed coronary artery interventions, patients who meet the selection and exclusion criteria for clinical trials with minor and secondary stenosis diseases that do not require intervention are evaluated as ultrasound in the vessel, and a random assignment (Table 1) is used for 1:1 random assignment in two groups: Group I: atorvastatin 10 mg + ezetimibe 10 mg once daily Group II: atorvastatin 40 mg once daily The institution intends to assess the quantitative and qualitative changes of the lithospheric plates by conducting a follow-up examination on the 3M,6M,9M after registration and on the 12M, ± 8weeks of coronary artery contrasting. |
Number of Arms | 2 |
Arm 1 |
Arm Label Study group / Group I |
Target Number of Participant 12 |
|
Arm Type Experimental |
|
Arm Description Atozet tab (atorvastatin 10 mg + ezetimibe 10 mg) once a day for 1year |
|
Arm 2 |
Arm Label control group / Group II |
Target Number of Participant 12 |
|
Arm Type Active comparator |
|
Arm Description atorvastatin 40 mg once a day for 1year |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E78.0)Pure hypercholesterolaemia coronary disease |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description Inclusion criteria 1) Patients with coronary artery disease who were 19 years of age or older and needed coronary angiography 2) Patients who needed percutaneous coronary intervention for coronary artery disease 3) Intermediate coronary artery stenosis (diameter stenosis ≥30% to ≤60% by visual estimation, diameter ≥2.0 mm to ≤4.0 mm, de novo lesion in native coronary artery) in which intravascular ultrasound could be feasible 4) Baseline serum LDL-C ≥ 70mg/dL 5) Patients who gave written informed consent |
|
Exclusion Criteria |
Exclusion criteria 1) Cardiogenic shock 2) Heart failure with symptoms of New York Heart Association class III/IV or left ventricular ejection fraction <35% 3) Renal dysfunction (creatinine level ≥1.7 mg/dL or dependence of dialysis 4) Pregnancy or breast-feeding women 5) Psychotic patient 6) Hepatic dysfunction (transaminase level > 3 times of normal within limit) 7) Patients with difficulty in assessing intravascular ultrasonography for the following reasons: severe calcification, severe tortuous vessels, total occlusion 8) Patients who can not receive adequate antiplatelet therapy 9) Thrombocytopenia (platelet count < 70x109/L) |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Percent atheroma volume of intermediate in the vascular wall of the mild and intermediate stenosis lesion after 12months Lipid-lowering Drug |
|
Timepoint | for 12 months |
|
Secondary Outcome(s) 1 | ||
Outcome | Percent atheroma volume in the vascular wall |
|
Timepoint | for 12 months |
|
Secondary Outcome(s) 2 | ||
Outcome | Lipid core burden index |
|
Timepoint | for 12 months |
|
Secondary Outcome(s) 3 | ||
Outcome | Absolute and percent changes in the lipid, glycemic and inflammatory profiles |
|
Timepoint | for 12 months |
11. Study Results and Publication
Result Registered |
Yes
Results Upload |
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Final Enrollment Number | 23 |
Number of Publication | 0 |
Results Upload | GCIRB2016-324(아토젯연구) 연구결과보고서.pdf |
Date of Posting Results | 2022/11/01 |
Protocol URL or File Upload | KCT0003431 연구계획서.pdf |
Brief Summary | Not applicable |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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