Not Yet RecruitingNot Applicable

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

5,000 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major Adverse Cardiovascular Events (MACE)

Timeframe: 2 year

Trial details

NCT IDNCT07626840

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

View on ClinicalTrials.gov More Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) trials