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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

Primary Purpose

Clinical Trial, Acute Coronary Syndrome

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Evolocumab
NIRS IVUS
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Trial focused on measuring evolocumab, Spectroscopy, Near-Infrared

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Statin+Ezetimibe

Statin+Ezetimibe+Evolocumab

Arm Description

Drug: Statin + Ezetimibe (combined cholesterol therapy)

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

Outcomes

Primary Outcome Measures

Change of 1-year lipid core burden index

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2021
Last Updated
October 3, 2023
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04719221
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Trial, Acute Coronary Syndrome
Keywords
evolocumab, Spectroscopy, Near-Infrared

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Statin+Ezetimibe
Arm Type
Placebo Comparator
Arm Description
Drug: Statin + Ezetimibe (combined cholesterol therapy)
Arm Title
Statin+Ezetimibe+Evolocumab
Arm Type
Active Comparator
Arm Description
Drug: Statin + Ezetimibe (combined cholesterol therapy) and Drug: Evolocumab
Intervention Type
Drug
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
Repatha
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
NIRS IVUS
Intervention Description
near-infrared spectroscopy
Primary Outcome Measure Information:
Title
Change of 1-year lipid core burden index
Time Frame
1 year
Secondary Outcome Measure Information:
Title
patient-oriented composite end point
Description
composite of all cause mortality, any myocardial infarction, and any revascularization
Time Frame
1 year
Title
Percentage of All cause mortality
Time Frame
1 year
Title
Percentage of cardiac death
Time Frame
1 year
Title
Percentage of myocardial infarction
Time Frame
1 year
Title
Percentage of revascularization
Time Frame
1 year
Title
Rate of usage of cholesterol lowering agents (2 month)
Time Frame
1 year
Title
Rate of usage of cholesterol lowering agents (12 month)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 19 years old 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 Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary syndrome 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: 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.) Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study Subjects who plan to have surgery to stop antiplatelet drugs within 12 months from registration Those whose surviving life is expected to be less than 1 year Subjects who visited the hospital due to psychogenic shock and are predicted to have low survival probability based on medical judgment Subjects participating in a randomized study on cholesterol therapy
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Joon Cha, MD, PhD
Phone
821089534950
Email
joonletter@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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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

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