Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients

NCT ID: NCT05761444

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2024-10-15

Brief Summary

This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.

Conditions

Atherosclerotic Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eze/Ato: Ezetimibe/Atorvastatin

Participants will receive ezetimibe/atorvastatin 10/40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C \< 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target level is not reached at Visit 3, dose is increased to ezetimibe/atorvastatin 10/80 mg QD from Visit 3 to Visit 4.

Group Type: EXPERIMENTAL

Atozet 10/40 mg or 10/80 mg

Intervention Type: DRUG

Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Ato: Atorvastatin

Participants will receive atorvastatin 40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C \< 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target is not reached at Visit 3, dose is increased to atorvastatin 80 mg QD from Visit 3 to Visit 4.

Group Type: ACTIVE_COMPARATOR

Lipitor 40 mg or 80 mg

Intervention Type: DRUG

Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Interventions

Atozet 10/40 mg or 10/80 mg

Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Intervention Type: DRUG

Lipitor 40 mg or 80 mg

Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who are ≥ 30 years old.

2. Patients with very high-risk*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020).

3. Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment

• rosuvastatin < 10 mg, atorvastatin < 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020).

4. Patients with LDL-C levels ≥ 70 mg/dL

5. Patients who are willing to maintain TLC throughout the study.

6. Patients who are willing to provide written informed consent prior to study enrollment.

Exclusion Criteria

1. Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients.

2. Patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) > 3 x upper limit of normal (ULN)).

3. Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease.

4. Patients with myasthenia gravis.

5. Female patients who are pregnant or have a potential to be pregnant and nursing.

6. Patients who are taking glecaprevir and pibrentasvir.

7. Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption.

8. Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia.

9. Patients with a history of cancer within 5 years.

10. Patients whose life expectancy is less than 6 months due to their medical conditions.

11. Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study.

12. Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period.

13. Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WonYoung Lee

Role: STUDY_DIRECTOR

Organon

Locations

Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea

Inje University Ilsan-Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Keimyung University Dongsan Medical Center

Daegu, Gyeongsangbuk-do, South Korea

Ulsan University Hospital

Ulsan, Gyeongsangnam-do, South Korea

Chonnam National University Hospital

Gwangju, Jeollanam-do, South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OG-KORATO-001

Identifier Type: -

Identifier Source: org_study_id