Moderate-Intensity Statin + Ezetimibe vs High-Intensity Statin in CKD with ASCVD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares two lipid-lowering strategies in CKD patients with ASCVD: moderate-intensity statin plus ezetimibe versus high-intensity statin monotherapy. Participants are stratified by diabetes status and dialysis use, then randomized 1:1 and followed for 36 months with visits at 4 weeks and every 6 months. The primary endpoint is a 3-year composite of cardiovascular events, while a key secondary endpoint is a ≥40% decline in eGFR. The study uses Pitavastatin or Atorvastatin with ezetimibe in the combination arm and Atorvastatin alone in the high-intensity arm. Lead sponsor is Yonsei University, and the trial is conducted at Severance Hospital in Seoul.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 19-85 years.
2. Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR \<60 / \<30 / \<15 mL/min/1.73 m² or on dialysis).
3. 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.

Exclusion Criteria:

1. Baseline LDL cholesterol \<55 mg/dL in the absence of statin therapy.
2. Acute liver disease or persistently unexplained serum AST/ALT ≥2 × the upper limit of normal.
3. Allergy or hypersensitivity to statins.
4. Life expectancy \<1 year.
5. Expected inability to complete at least 1 year of follow-up.
6. Inability to read or understand the informed consent form.

Where it's running

• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jung-Sun Kim, Professor
• Email: kjs1218@yuhs.ac
• Phone: +82-2-2228-8460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.