Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorYonsei University
About this 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.
Eligibility criteria
Qualifiers
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).
Prior acute coronary syndrome (myocardial infarction or unstable angina).
Stable angina confirmed by imaging studies.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Moderate-intensity statin and ezetimibe combination therapy
- High-intensity statin monotherapy
Treatment groups
1,952 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov