Clinical trial NCT04719221: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Clinical Trial
Acute Coronary Syndrome
Keywords: evolocumab
Spectroscopy, Near-Infrared
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of 1-year lipid core burden index
timeFrame: 1 year
Secondary outcomes:
measure: patient-oriented composite end point
timeFrame: 1 year
measure: Percentage of All cause mortality
timeFrame: 1 year
measure: Percentage of cardiac death
timeFrame: 1 year
measure: Percentage of myocardial infarction
timeFrame: 1 year
measure: Percentage of revascularization
timeFrame: 1 year
measure: Rate of usage of cholesterol lowering agents (2 month)
timeFrame: 1 year
measure: Rate of usage of cholesterol lowering agents (12 month)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
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