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Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

ConditionsRenal InsufficiencyAtherosclerosisDyslipidemiaHypercholesterolemiaCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorYonsei University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,952 Participants
are divided into 2 treatment groups
Group A: Moderate-intensity statin and ezetimibe combination therapyExperimental treatment 1 intervention
Group B: High-intensity statin monotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular events

Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.

Time frame
3 years

Secondary outcomes

1

CKD progression

CKD progression: ≥40% decline in eGFR from baseline, confirmed on at least two consecutive measurements during follow-up.

Time frame
3 years
2

Cardiovascular death.

Death due to cardiovascular causes during follow-up.

Time frame
3 years
3

Myocardial infarction.

Occurrence of myocardial infarction during follow-up.

Time frame
3 years
4

Stroke.

Occurrence of stroke during follow-up

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov
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