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

NCT04719221 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: ELoNirs-ACS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Trial; Acute Coronary Syndrome

Keywords

evolocumab; Spectroscopy, Near-Infrared

Outcome Measures

Primary Outcomes (1)

• Change of 1-year lipid core burden index

  1 year

Secondary Outcomes (7)

• patient-oriented composite end point

  1 year

• Percentage of All cause mortality

  1 year

• Percentage of cardiac death

  1 year

• Percentage of myocardial infarction

  1 year

• Percentage of revascularization

  1 year

Study Arms (2)

Statin+Ezetimibe

PLACEBO COMPARATOR

Drug: Statin + Ezetimibe (combined cholesterol therapy)

Drug: Evolocumab; Device: NIRS IVUS

Statin+Ezetimibe+Evolocumab

ACTIVE COMPARATOR

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

Drug: Evolocumab; Device: NIRS IVUS

Interventions

Evolocumab DRUG

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.

Also known as: Repatha

Statin+Ezetimibe; Statin+Ezetimibe+Evolocumab

NIRS IVUS DEVICE

near-infrared spectroscopy

Statin+Ezetimibe; Statin+Ezetimibe+Evolocumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 22, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

KR (1)