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

October 3, 2023 updated by: Jung-Joon Cha, Korea University Anam Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELoNirs-ACS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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