Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07524101
NA

Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

Sponsor: Yonsei University

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

High-intensity statin monotherapy

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