Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome

Study Overview
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Brief Summary
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This study aimed to investigate the impact of intensive cholesterol-lowering therapy (including evolocumab), drug treatment for high-risk plaques (Vulnerable plaques) with a high probability of developing acute coronary syndrome. The purpose of this study is to determine the effect of the change in the Lipid core burden index and compare the rate of cardiac events over 12 months following cholesterol therapy.

Official Title
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A Single-center, Randomized, Parallel-group, Open-label Pilot Study to Evaluate the Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome

Conditions
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Clinical Trial, Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Evolocumab
* Device: NIRS IVUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 19 years old Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary syndrome Patients who did not meet the LDL-Cholesterol level (<70mg/dL) even after receiving the maximum dose of combined cholesterol therapy for 2 months Exclusion Criteria: Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.) Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study Subjects who plan to have surgery to stop antiplatelet drugs within 12 months from registration Those whose surviving life is expected to be less than 1 year Subjects who visited the hospital due to psychogenic shock and are predicted to have low survival probability based on medical judgment Subjects participating in a randomized study on cholesterol therapy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Statin+Ezetimibe<br>Drug: Statin + Ezetimibe (combined cholesterol therapy) | Drug: Evolocumab<br>* The maximum dose of combined cholesterol therapy (Statin + Ezetimibe) is prescribed for 2 months, and a cholesterol test is performed in an outpatient clinic to ensure that LDL-Cholesterol <70mg/dL is met. Patients who do not meet the criteria are randomized to maintain current treatment or receive additional Evolocumab according to randomization.<br>* Other names: Repatha;Device: NIRS IVUS<br>* near-infrared spectroscopy<br>|
| Active Comparator: Statin+Ezetimibe+Evolocumab<br>Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab | Drug: Evolocumab<br>* The maximum dose of combined cholesterol therapy (Statin + Ezetimibe) is prescribed for 2 months, and a cholesterol test is performed in an outpatient clinic to ensure that LDL-Cholesterol <70mg/dL is met. Patients who do not meet the criteria are randomized to maintain current treatment or receive additional Evolocumab according to randomization.<br>* Other names: Repatha;Device: NIRS IVUS<br>* near-infrared spectroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 1-year lipid core burden index |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-oriented composite end point | composite of all cause mortality, any myocardial infarction, and any revascularization | 1 year | 
| Percentage of All cause mortality |  | 1 year | 
| Percentage of cardiac death |  | 1 year | 
| Percentage of myocardial infarction |  | 1 year | 
| Percentage of revascularization |  | 1 year | 
| Rate of usage of cholesterol lowering agents (2 month) |  | 1 year | 
| Rate of usage of cholesterol lowering agents (12 month) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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evolocumab, Spectroscopy, Near-Infrared