drugset / Trial / NCT06785974

Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis

NCT06785974

Phase 4 Not yet recruiting 140 enrolled Erasmus Medical Center Amphia Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The goal of this interventional study is to test whether atorvastatin prevents accelerated progression of atherosclerosis in melanoma patients who receive immune checkpoint inhibitor (ICI) therapy. The main questions it aims to answer are: * difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in the descending thoracic segment of the aorta * difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in coronary arteries. Researchers will compare patients that receive ICI-therapy and atorvastatin with patients that receive ICI-therapy + placebo to see if atorvastatin will prevent accelerated ICI induced plaque growth.

Timeline

Start
2025-02
Primary completion
2027-02
Completion
2030-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg