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

Phase 4

Recruiting

• Conditions: Clinical Trial; Acute Coronary Syndrome
• Interventions: Drug: Evolocumab; Device: NIRS IVUS

• Registration Number: NCT04719221
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Study Start: 2021-03-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Over 19 years old
2. 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
3. Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary syndrome
4. Patients who did not meet the LDL-Cholesterol level (<70mg/dL) even after receiving the maximum dose of combined cholesterol therapy for 2 months

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Exclusion Criteria

1. 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.)
2. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
3. Subjects who plan to have surgery to stop antiplatelet drugs within 12 months from registration
4. Those whose surviving life is expected to be less than 1 year
5. Subjects who visited the hospital due to psychogenic shock and are predicted to have low survival probability based on medical judgment
6. Subjects participating in a randomized study on cholesterol therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin+Ezetimibe	Evolocumab	Drug: Statin + Ezetimibe (combined cholesterol therapy)
Statin+Ezetimibe	NIRS IVUS	Drug: Statin + Ezetimibe (combined cholesterol therapy)
Statin+Ezetimibe+Evolocumab	Evolocumab	Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab
Statin+Ezetimibe+Evolocumab	NIRS IVUS	Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab

Primary Outcome Measures

Name	Time	Method
Change of 1-year lipid core burden index	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of