Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

Официальное название

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

Обзор

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.

Подробное описание

All eligible patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD) will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent.

At the time of enrollment, we will stratify the patients according to diabetes mellitus and dialysis status, and randomly assign them in two groups according to lipid-lowering regimen with a 1:1 ratio: "Moderate-intensity statin plus ezetimibe group" vs. "High-intensity statin monotherapy group".

In this study, the combination therapy strategy will utilize Pitavastatin 1-4 mg plus Ezetimibe 10 mg once daily or Atorvastatin 10-20 mg plus Ezetimibe 10 mg once daily. The monotherapy strategy will utilize Atorvastatin 40 mg once daily.

Study visits are scheduled at 4 weeks and at 6, 12, 18, 24, 30, and 36 months. The primary outcome is the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary outcome is CKD progression defined as a ≥40% decline in eGFR confirmed on at least two consecutive measurements

Вмешательства

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

Первичные конечные точки

• Major adverse cardiovascular events [Срок оценки: 3 years]

Вторичные конечные точки (12)

• CKD progression [Срок оценки: 3 years]
• Cardiovascular death. [Срок оценки: 3 years]
• Myocardial infarction. [Срок оценки: 3 years]
• Stroke. [Срок оценки: 3 years]
• Hospitalization for unstable angina. [Срок оценки: 3 years]
• Coronary revascularization. [Срок оценки: 3 years]
• Composite of cardiovascular death, myocardial infarction, and stroke. [Срок оценки: 3 years]
• Composite of cardiovascular death, myocardial infarction, stroke, and hospitalization for unstable angina [Срок оценки: 3 years]
• Composite of cardiovascular death, myocardial infarction, stroke, and coronary revascularization. [Срок оценки: 3 years]
• Composite of all-cause death, myocardial infarction, stroke, hospitalization for unstable angina, and coronary revascularization. [Срок оценки: 3 years]
• Proportion of participants achieving the LDL-C <70 mg/dL in each group. [Срок оценки: 3 years]
• Proportion of participants achieving LDL-C <55 mg/dL in each group. [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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).
• Established ASCVD, meeting at least one of the following:

• Prior acute coronary syndrome (myocardial infarction or unstable angina).
• Stable angina confirmed by imaging studies.
• History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).
• Peripheral artery disease.
• Ischemic stroke or transient ischemic attack.

Критерии исключения

• 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.
• Expected inability to complete at least 1 year of follow-up.
• Inability to read or understand the informed consent form.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Severance Hospital — Seoul

Идентификаторы

NCT: NCT07524101 · 4-2025-1647

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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