Clinical Research Directory
Browse clinical research sites, groups, and studies.
Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
Sponsor: Yonsei University
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.
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
Key Details
Gender
All
Age Range
19 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
1952
Start Date
2026-06-01
Completion Date
2031-01-22
Last Updated
2026-04-23
Healthy Volunteers
No
Interventions
Moderate-intensity statin and ezetimibe combination therapy
Participants will receive moderate-intensity statin plus ezetimibe (pitavastatin 4 mg + ezetimibe 10 mg once daily or atorvastatin 20 mg + ezetimibe 10 mg once daily), with 36-month follow-up.
High-intensity statin monotherapy
Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.