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Clinical Trials in South Korea / NCT07524101
Recruiting Not applicable

Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

NCT07524101 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2026-05-28
Last updated
2026-06-16

Condition(s) studied

Renal InsufficiencyAtherosclerosisDyslipidemiaHypercholesterolemiaCardiovascular Diseases

Investigational drug(s) / intervention(s)

Moderate-intensity statin and ezetimibe combination therapyHigh-intensity statin monotherapy →

Moderate-intensity statin and ezetimibe combination therapy: Participants will receive moderate-intensity statin plus ezetimibe (pitavastatin 1-4 mg + ezetimibe 10 mg once daily or atorvastatin 10-20 mg + ezetimibe 10 mg once daily), with 36-month follow-up.

High-intensity statin monotherapy: Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.

Study summary

The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD).

Patients with CKD are at very high risk for ASCVD. In this population, it is important to establish a lipid-lowering strategy that optimizes cardiovascular outcomes while ensuring long-term safety. While high-intensity statins are generally considered as initial treatment option for secondary prevention, the optimal strategy for CKD patients remains to be clinicaly defined. This study aims to evaluate whether the combination of moderate-intensity statin and ezetimibe is non-inferior to high-intensity statin monotherapy in terms of 3-year composite of major adverse cardiovascular events.

Eligibility

Sex
ALL
Min age
19 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 19-85 years. 2. Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR \<60 / \<30 / \<15 mL/min/1.73 m² or on dialysis). 3. Established ASCVD, meeting at least one of the following: * Prior acute coronary syndrome (myocardial infarction or unstable angina). * Stable angina confirmed by imaging studies. * History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting). * Peripheral artery disease. * Ischemic stroke or transient ischemic attack. Exclusion Criteria: 1. Baseline LDL cholesterol \<55 mg/dL in the absence of statin therapy. 2. Acute liver disease or persistently unexplained serum AST/ALT ≥2 × the upper limit of normal. 3. Allergy or hypersensitivity to statins. 4. Life expectancy \<1 year. 5. Expected inability to complete at least 1 year of follow-up. 6. Inability to read or understand the informed consent form.

Primary outcome measure(s)

  • Major adverse cardiovascular events — 3 years
    Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.

Trial sites (1)

FacilityCityRegionStatus
Severance Hospital Seoul South Korea Recruiting

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Other trials for the same condition

Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes Starting soon
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe Recruiting
Comparison of Intensive Versus Standard Care & Education for Dyslipidemia in Hypertension and Diabetes Patients Recruiting
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C714 and C714R in Healthy Adults Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07524101 on ClinicalTrials.gov ↗ ← All trials in South Korea