Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Able to understand the written information and able to give informed consent
Melanoma diagnosis with planned ICI treatment according to standard of care (nivolumab, pembrolizumab, monotherapy or combination therapy with ipilimumab)
Presence of atherosclerosis in the descending thoracic aorta at baseline.
Disqualifiers
Pregnancy or lactation
Baseline statin use or previously reported statin intolerance
Current or recent (≤1 year) history of alcohol or drug abuse
Active liver disease, including ALT/AST levels ≥ 3x ULN
Trial design
Treatments tested in this trial
- Atorvastatin
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Erasmus Medical Center
Lead sponsor
Amphia Hospital
Collaborator
Source ClinicalTrials.gov