Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderate-intensity statin and ezetimibe combination therapy, High-intensity statin monotherapy.
- Who it may be relevant to
- Registry conditions: Renal Insufficiency, Atherosclerosis, Dyslipidemia, Hypercholesterolemia. Basic parameters: 19 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial
Overview
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.
Detailed description
All eligible patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD) will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent.
At the time of enrollment, we will stratify the patients according to diabetes mellitus and dialysis status, and randomly assign them in two groups according to lipid-lowering regimen with a 1:1 ratio: "Moderate-intensity statin plus ezetimibe group" vs. "High-intensity statin monotherapy group".
In this study, the combination therapy strategy will utilize Pitavastatin 1-4 mg plus Ezetimibe 10 mg once daily or Atorvastatin 10-20 mg plus Ezetimibe 10 mg once daily. The monotherapy strategy will utilize Atorvastatin 40 mg once daily.
Study visits are scheduled at 4 weeks and at 6, 12, 18, 24, 30, and 36 months. The primary outcome is the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary outcome is CKD progression defined as a ≥40% decline in eGFR confirmed on at least two consecutive measurements
Interventions
- Drug 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. - Drug High-intensity statin monotherapy
Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.
Primary outcome measures
- Major adverse cardiovascular events [Time frame: 3 years]
Secondary outcome measures (12)
- CKD progression [Time frame: 3 years]
- Cardiovascular death. [Time frame: 3 years]
- Myocardial infarction. [Time frame: 3 years]
- Stroke. [Time frame: 3 years]
- Hospitalization for unstable angina. [Time frame: 3 years]
- Coronary revascularization. [Time frame: 3 years]
- Composite of cardiovascular death, myocardial infarction, and stroke. [Time frame: 3 years]
- Composite of cardiovascular death, myocardial infarction, stroke, and hospitalization for unstable angina [Time frame: 3 years]
- Composite of cardiovascular death, myocardial infarction, stroke, and coronary revascularization. [Time frame: 3 years]
- Composite of all-cause death, myocardial infarction, stroke, hospitalization for unstable angina, and coronary revascularization. [Time frame: 3 years]
- Proportion of participants achieving the LDL-C <70 mg/dL in each group. [Time frame: 3 years]
- Proportion of participants achieving LDL-C <55 mg/dL in each group. [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
- Allergy or hypersensitivity to statins.
- Life expectancy <1 year.
- Expected inability to complete at least 1 year of follow-up.
- Inability to read or understand the informed consent form.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Severance Hospital — Seoul
Identifiers
NCT: NCT07524101 · 4-2025-1647