Comparing Moderate-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Alone in Adults With Chronic Kidney Disease and Heart Disease

What this Trial Is About

Researchers are evaluating treatments for patients with chronic kidney disease CKD and atherosclerotic cardiovascular disease ASCVD in the ULTRA-CKD trial. This study compares the combination of moderate-intensity statin plus ezetimibe against high-intensity statin alone to find the best approach for lowering cardiovascular risks and ensuring safety in this high-risk group. The main goal is to see if the combination therapy is not worse than high-intensity statin monotherapy over three years regarding major heart-related events. Participants are randomly assigned to one of two treatment groups one receives moderate-intensity statin plus ezetimibe daily either pitavastatin 1-4 mg or atorvastatin 10-20 mg with ezetimibe 10 mg, and the other receives high-intensity statin alone atorvastatin 40 mg daily. The study follows patients for 36 months, with visits scheduled at 4 weeks, 6 months, and then every 6 months up to 36 months. The treatments are taken orally once daily. During the study, participants undergo regular assessments including cardiovascular event tracking and kidney function monitoring. The main outcome measured is a combined rate of major cardiovascular events such as heart attack, stroke, and hospitalization over three years. Secondary outcomes include kidney function decline, new diabetes cases, and various safety measures such as muscle symptoms and liver enzymes. Follow-up visits help researchers monitor health, medication effects, and adherence throughout the trial period.

Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD