NCT06785974Not yet recruitingPhase 4
Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 16 Dec 2024
- Start date
- Feb 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Melanoma
- NCT number
- NCT06785974
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 140
- From Feb 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Baseline statin use or previously reported statin intolerance
Other illness
- Current or recent (≤1 year) history of alcohol or drug abuse
- 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)
Lab values
- 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)
Other
- Pregnancy or lactation
- Life expectancy \< 12 months
- High MESA-score at baseline
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Universitair Medisch Cetrum Rotterdam Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.