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NOT YET RECRUITING
NCT06785974
PHASE4

Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis

Sponsor: Erasmus Medical Center

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-02

Completion Date

2030-02

Last Updated

2025-01-22

Healthy Volunteers

No

Interventions

DRUG

Atorvastatin

Daily 20mg atorvastatin.

DRUG

Placebo

Daily Placebo in combination with ICI-therapy

Locations (1)

Erasmus Universitair Medisch Cetrum Rotterdam

Rotterdam, South Holland, Netherlands