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Recruiting
NCT07524101
Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
Conditions: Renal Insufficiency, Atherosclerosis, Dyslipidemia, Hypercholesterolemia, Cardiovascular Diseases
Sex: All
Ages: 19 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 1952
Sponsor: Yonsei University
Location: Severance Hospital Seoul
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 Criteria
Inclusion Criteria:
1. Age 19-85 years.
2. Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR \
Source: ClinicalTrials.gov (NCT07524101). StuddyBuddy aggregates publicly available trial information.