Clinical trial · Interventional
Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atherosclerosis | — | UNRESOLVED | — |
| Immune-related Adverse Event | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention/ Atorvastatin arm
- description
- Patient will receive 20mg of atorvastatin daily together with ICI-therapy
- interventionNames
- Drug: Atorvastatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- Patient will receive placebo daily together with ICI-therapy
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Percentual annual growth of atherosclerotic plaques in the descending thoracic aorta
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * In order to be eligible to participate in this study, a subject must meet all of the following criteria: * 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. Exclusion Criteria: * Pregnancy or lactation * Baseline statin use or previously reported statin intolerance * Current or recent (≤1 year) history of alcohol or drug abuse * Contra-indication for statin therapy, including: * Active liver disease, including ALT/AST levels ≥ 3x ULN * (History of) myopathy Congenital muscular disorder History of (drug-induced) rhabdomyolysis History of drug-induced myopathy with elevated creatine kinase (CK) * Severe kidney failure (creatinine clearance \< 30 ml/min) * Use of essential medication with (potential) interactions with atorvastatin, including: * strong CYP3A4 inhibitors such as clarithromycin, ciclosporin, itraconazol, ketoconazole, voriconazol, posconazol, HCV agents, HIV protease inhibitors * BCRP inhibitors such as elbasvir and grazoprevir * Fibrates (including gemfibrozil) * Life expectancy \< 12 months * High MESA-score at baseline
References
Publications (0)
Data not yet available