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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

Sponsor
Korea University Anam Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04719221
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
45
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Statin+Ezetimibe

Drug: Statin + Ezetimibe (combined cholesterol therapy)

Drug: Evolocumab
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.
Other Names:
  • Repatha

    • Device: NIRS IVUS
    near-infrared spectroscopy
    Active Comparator: Statin+Ezetimibe+Evolocumab

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

    Drug: Evolocumab
    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.
    Other Names:
  • Repatha

    • Device: NIRS IVUS
    near-infrared spectroscopy

    Outcome Measures

    Primary Outcome Measures

    1. Change of 1-year lipid core burden index [1 year]

    Secondary Outcome Measures

    1. patient-oriented composite end point [1 year]

      composite of all cause mortality, any myocardial infarction, and any revascularization

    2. Percentage of All cause mortality [1 year]

    3. Percentage of cardiac death [1 year]

    4. Percentage of myocardial infarction [1 year]

    5. Percentage of revascularization [1 year]

    6. Rate of usage of cholesterol lowering agents (2 month) [1 year]

    7. Rate of usage of cholesterol lowering agents (12 month) [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Anam Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Korea University Anam Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jung-Joon Cha, Assistant Professor, Korea University Anam Hospital
    ClinicalTrials.gov Identifier:
    NCT04719221
    Other Study ID Numbers:
    • ELoNirs-ACS
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jung-Joon Cha, Assistant Professor, Korea University Anam Hospital
    evolocumab
    Spectroscopy, Near-Infrared
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Evolocumab

    Study Results

    No Results Posted as of Mar 31, 2022