drugset / Trial / NCT07524101

Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

NCT07524101

Recruiting 1952 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-28
Primary completion
2031-01-22
Completion
2031-01-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 10 mg
Comparator Atorvastatin Small molecule 20 mg
Comparator Atorvastatin Small molecule 40 mg
Subject Ezetimibe Unknown 10 mg
Subject Pitavastatin Small molecule 1 mg
Subject Pitavastatin Small molecule 4 mg