Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

Sponsor
Yonsei University
Study ID
NCT07524101
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Moderate-intensity statin and ezetimibe combination therapy — DRUG
    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.
  • High-intensity statin monotherapy — DRUG
    Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
May 28, 2026
Status verified
Jun 2026
Primary completion
Jan 22, 2031
Completion
Jan 22, 2031

Study Design

Enrollment
1,952 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Moderate-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.
  • Active Comparator: High-intensity statin monotherapy
    Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.

Primary Outcome Measure

Major adverse cardiovascular events [ Time Frame: 3 years ]

Central Contacts

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