RecruitingNot ApplicableNCT07524101

Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial


Sponsor

Yonsei University

Enrollment

1,952 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called High-intensity statin monotherapy and a drug called Moderate-intensity statin and ezetimibe combination therapy for people with atherosclerosis, cardiovascular diseases, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGModerate-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.

DRUGHigh-intensity statin monotherapy

Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.


Locations(1)

Severance Hospital

Seoul, South Korea

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NCT07524101


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