Health Trials

About this trial

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 criteria

Qualifiers

Age 19-85 years.

Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR <60 / <30 / <15 mL/min/1.73 m² or on dialysis).

Prior acute coronary syndrome (myocardial infarction or unstable angina).

Stable angina confirmed by imaging studies.

Disqualifiers

Baseline LDL cholesterol <55 mg/dL in the absence of statin therapy.

Acute liver disease or persistently unexplained serum AST/ALT ≥2 × the upper limit of normal.

Allergy or hypersensitivity to statins.

Life expectancy <1 year.

Trial design

Treatments tested in this trial

  • Moderate-intensity statin and ezetimibe combination therapy
  • High-intensity statin monotherapy

Treatment groups

1,952 Participants
are divided into 2 treatment groups

Locations

1
Severance Hospital03722, Seoul South Korea

Sponsors and collaborators

Yonsei University

Lead sponsor

Source ClinicalTrials.gov