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

Korea University

Status and phase: Enrolling; Phase 4

Conditions: Acute Coronary Syndrome; Clinical Trial

Treatments: Drug: Evolocumab; Device: NIRS IVUS

Study type: Interventional

Funder types: Other

Identifiers

NCT04719221

ELoNirs-ACS

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Statin+Ezetimibe

Placebo Comparator group

Description:

Drug: Statin + Ezetimibe (combined cholesterol therapy)

Treatment:

Drug: Evolocumab

Device: NIRS IVUS

Statin+Ezetimibe+Evolocumab

Active Comparator group

Description:

Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab

Treatment:

Drug: Evolocumab

Device: NIRS IVUS