Statin Plus Ezetimibe Versus High-Dose Statin in Kidney Disease With Heart Artery Disease
Compares two cholesterol-lowering approaches in people with chronic kidney disease and atherosclerotic cardiovascular disease.
Plain-language title generated from the registry record
Registry title: Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
Key facts
- Where
- Seoul, South KoreaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 85 years old?
Source: NCT07524101, who can take part
Where in South Korea
- Severance hospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yonsei University
- Trial code
- NCT07524101
- Record updated
- 16 June 2026
- Original description
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).Read full original descriptionShow less
Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial
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.
Inclusion: Age 19-85 years; Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR <60 / <30 / <15 mL/min/1.73 m² or on dialysis); 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: Allergy or hypersensitivity to statins; Baseline LDL cholesterol <55 mg/dL in the absence of statin therapy; Acute liver disease or persistently unexplained serum AST/ALT ≥2 × the upper limit of normal; Life expectancy <1 year; Expected inability to complete at least 1 year of follow-up; Inability to read or understand the informed consent form.