Livalozet Versus High-intensity Statin in Older Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

NCT07626840 | Not Yet Recruiting DMC

• 1 other identifier: SMC2025-11-105
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute myocardial infarction is one of the leading causes of death in elderly patients, and the importance of lipid-lowering therapy as a secondary prevention strategy to reduce cardiovascular events is emphasized. The European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines recommend lowering low-density lipoprotein-cholesterol (LDL-C) below 55 mg/dL or by at least 50% from baseline as a treatment goal and recommend high-intensity statin therapy (Atorvastatin 40-80 mg, Rosuvastatin 20 mg). Statins have been shown to reduce cardiovascular risk in elderly patients as well. However, these patients exhibit a higher rate of statin intolerance due to side effects associated with high-intensity statins, such as myalgia, hepatotoxicity, cognitive decline, and increased risk of diabetes. Consequently, dose reduction or discontinuation is required more frequently compared to younger patients. Therefore, establishing an appropriate lipid-lowering strategy for elderly patients is necessary, considering not only efficacy but also drug tolerability. Consequently, in elderly patients, reducing the statin intensity from the outset and considering combination therapy with drugs having different mechanisms of action, such as ezetimibe, may be warranted. Pitavastatin is classified as a moderate-intensity statin. Previous studies have confirmed that Pitavastatin demonstrates non-inferior efficacy compared to Rosuvastatin and Atorvastatin. Several observational studies report that Pitavastatin has fewer drug interactions than other statins and lower rates of diabetes onset and elevated liver enzymes. Therefore, Pitavastatin may be an appropriate choice for moderate-intensity statin therapy in elderly patients. Thus, this study aims to evaluate whether combination therapy with Pitavastatin and Ezetimibe (Livalozet 4/10mg) after coronary intervention in patients aged 75 years or older with coronary artery disease is non-inferior to high-intensity statin therapy (Atorvastatin 40-80 mg or Rosuvastatin 20 mg). If this study demonstrates that moderate-intensity statin therapy combined with ezetimibe is non-inferior to high-intensity statin therapy while also having fewer adverse effects, it could provide evidence for an effective and safe cholesterol treatment option for elderly patients.

Conditions

Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  A composite of cardiovascular death, MI, stroke, and unplanned revascularization

  2 year

Secondary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  5 year

Study Arms (2)

pitavastatin/ezetimibe combination therapy group

EXPERIMENTAL

Livalozet 4/10mg once daily orally, continue until follow-up is complete.

Drug: Pitavastatin/ezetimibe

high-intensity statin monotherapy group

ACTIVE COMPARATOR

Atorvastatin 40 mg, 80 mg or Rosuvastatin 20 mg once daily orally, continue until follow-up is complete.

Drug: Atorvastatin or Rosuvastatin

Interventions

Pitavastatin/ezetimibe DRUG

Livalozet 4/10mg will be administered once daily orally according to the study protocol.

Also known as: Livalozet 4/10mg

pitavastatin/ezetimibe combination therapy group

Atorvastatin or Rosuvastatin DRUG

Atorvastatin 40 mg, 80 mg or Rosuvastatin 20 mg once daily orally as determined by the physician.

Also known as: rosuvastatin, atorvastatin

high-intensity statin monotherapy group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 75 years or older
• Patients diagnosed with stable coronary artery disease or acute coronary syndrome and requiring coronary artery intervention due to coronary artery stenosis
• Patients with primary hypercholesterolemia and mixed dyslipidemia
• Patients who understand the risks and benefits of treatment, as well as alternatives, and can voluntarily sign the informed consent form

You may not qualify if:

• Patients with hypersensitivity or contraindications to statins or ezetimibe
• Patients with active liver disease or persistently elevated AST or ALT levels exceeding three times the upper limit of normal
• Patients with a history of organ transplantation (kidney, liver, etc.)
• Pregnant or lactating women
• Patients with a life expectancy of less than one year due to non-cardiac disease, or those deemed unable to participate in the study and follow-up (based on the medical judgment of the investigator at each site)

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

pitavastatin; Ezetimibe; Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 10, 2026

Record last verified: 2026-06