Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI

NCT05661552 | Completed Phase 4

• 1 other identifier: 9-2022-0119
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI

Conditions

Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Keywords

acute coronary syndrome; low-density-lipoprotein; PCSK9 inhibitor

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL level (%)

  Difference in LDL level change between baseline and 2 weeks later in the test group and control group

  Baseline, 2 weeks later

Secondary Outcomes (9)

• Percent change in LDL level (%)

  baseline, 2 weeks later 4 weeks later

• Differences in LDL level change (mg/dL)

  baseline, 2 weeks later 4 weeks later

• Presence or absence of side effects

  baseline, 2 weeks later 4 weeks later

• Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level

  baseline, 2 weeks later 4 weeks later

• Creatine kinase(CK) (IU/L)

  baseline, 2 weeks later 4 weeks later

Study Arms (2)

Evolocumab treatment group

EXPERIMENTAL

The experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period.

Drug: Evolocumab 140 MG/ML; Drug: Rosuvastatin 5mg; Drug: Ezetimibe 10mg

Group not receiving evolocumab

ACTIVE COMPARATOR

The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg.

Drug: Rosuvastatin 5mg; Drug: Ezetimibe 10mg

Interventions

Evolocumab 140 MG/ML DRUG

Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe

Also known as: REPATHA® (Amgen Inc, Thousand Oaks, California, USA)

Evolocumab treatment group

Rosuvastatin 5mg DRUG

Rosuvastatin 5mg will be assigned to all participants

Evolocumab treatment group; Group not receiving evolocumab

Ezetimibe 10mg DRUG

Ezetimibe 10mg will be assigned to all participants

Evolocumab treatment group; Group not receiving 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 agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form.
• Patients who underwent percutaneous coronary stenting for acute coronary syndrome

You may not qualify if:

• Patients who have previously taken statins,
• Patients with active liver disease or patients with three times or more increase in AST or ALT
• If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib,
• Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
• The remaining life expectancy is expected to be less than a year.
• Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment
• Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals

Sponsors & Collaborators

• Yonsei University: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Yongcheol Kim

Yongin, Gyeonggi-do, 16995, South Korea

Location

Related Publications (1)

• Roh JW, Lee OH, Kim Y, Heo SJ, Im E, Cho DK. Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. Korean Circ J. 2026 Jan 6. doi: 10.4070/kcj.2025.0315. Online ahead of print.

  PMID: 41560483 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

evolocumab; Rosuvastatin Calcium; Ezetimibe

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azetidines; Azetines

Study Officials

• Yongcheol Kim, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

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: Clinical Associate Professor

Model Details: The experimental and control groups consist of patients undergoing stenting for acute coronary syndrome and will be randomized to receive early evolocumab along with statin/ezetimibe use or no evolocumab. Rosuvastatin 5 mg and Ezetimibe 10 mg are administered to both the experimental group and the control group.

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 22, 2022
• Study Start: December 1, 2022
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)