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Statins to Prevent Immune checkpoint inhibitor-induced pRogression of AtheroscLerosis
EU CTIS ID: 2024-511127-33-00
What this study is testing
The main objective of this trial is to study whether atorvastatin prevents accelerated progression of atherosclerosis during ICI therapy, as measured in the thoracic aorta between the intervention and control group.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with melanoma who are scheduled to receive ICI therapy (nivolumab, pembrolizumab, ipilimumab or combination therapy) according to standard-of-care.
- Age ≥ 18 years
- Able to understand the written information and able to give informed consent
- Presence of thoracic aortic atherosclerosis at baseline, defined as: presence of vessel wall calcifications in the thoracic aorta, and/or vessel wall irregularity of the thoracic aorta, and/or presence of an apparent thickening of the vessel wall with a hypodense aspect in the thoracic aorta
You likely can't join if
- Baseline statins use or previously reported statin intolerance
- Pregnancy or lactation
- Current or recent (≤1 year) history of alcohol (≥3 consumptions/day) or drug abuse
- Contra-indication for statin therapy, including: active liver disease, including ALT/AST levels ≥ 3x ULN, and/or (History of) myopathy, and/or congenital muscular disorder, and/or history of (drug-induced) rhabdomyolysis, and/or history of drug-induced myopathy with elevated creatine kinase (CK)
- Use of essential medication with (potential) interactions with atorvastatin, including: Strong CYP3A4 inhibitors (such as clarithromycin, ciclosporin, itraconazole, ketoconazole, voriconazole, posaconazole, HCV agents, HIV protease inhibitors), and/or BCRP inhibitors (such as elbasvir and grazoprevir), and/or Fibrates (including gemfibrozil)
- Indication for statin treatment according to the 2024 Dutch multi-disciplinary CVRM guidelines, unless the participant indicates he/she is not willing to use statin outside the trial and has provided explicit written informed consent in which they state that they understand their indication for statin therapy, the medical recommendation to initiate treatment outside the study, and the potential to receive placebo within the study.
See the full eligibility criteria
- Patients with melanoma who are scheduled to receive ICI therapy (nivolumab, pembrolizumab, ipilimumab or combination therapy) according to standard-of-care.
- Age ≥ 18 years
- Able to understand the written information and able to give informed consent
- Presence of thoracic aortic atherosclerosis at baseline, defined as: presence of vessel wall calcifications in the thoracic aorta, and/or vessel wall irregularity of the thoracic aorta, and/or presence of an apparent thickening of the vessel wall with a hypodense aspect in the thoracic aorta
- Baseline statins use or previously reported statin intolerance
- Pregnancy or lactation
- Current or recent (≤1 year) history of alcohol (≥3 consumptions/day) or drug abuse
- Contra-indication for statin therapy, including: active liver disease, including ALT/AST levels ≥ 3x ULN, and/or (History of) myopathy, and/or congenital muscular disorder, and/or history of (drug-induced) rhabdomyolysis, and/or history of drug-induced myopathy with elevated creatine kinase (CK)
- Use of essential medication with (potential) interactions with atorvastatin, including: Strong CYP3A4 inhibitors (such as clarithromycin, ciclosporin, itraconazole, ketoconazole, voriconazole, posaconazole, HCV agents, HIV protease inhibitors), and/or BCRP inhibitors (such as elbasvir and grazoprevir), and/or Fibrates (including gemfibrozil)
- Indication for statin treatment according to the 2024 Dutch multi-disciplinary CVRM guidelines, unless the participant indicates he/she is not willing to use statin outside the trial and has provided explicit written informed consent in which they state that they understand their indication for statin therapy, the medical recommendation to initiate treatment outside the study, and the potential to receive placebo within the study.
- Significant obstructive coronary artery disease (>50% LM stenosis or >70% of proximal LAD, Cx or RCA segment, or multivessel significant more distal disease)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.