Clinical Trial

Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis

Study acronym: SPIRAL
Not Yet Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT06785974
Lead Sponsor Erasmus Medical Center
Collaborators: Amphia Hospital
Conditions Atherosclerosis, Melanoma, Immune-related Adverse Event
Enrollment 140 participants
Start Date 2025-02
Primary Completion 2027-02 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2025-01-22