AuthorisedTherapeutic use (Phase IV)Interventional

Statins to Prevent Immune checkpoint inhibitor-induced pRogression of AtheroscLerosis

This research is investigating if a widely used cholesterol-lowering medication, atorvastatin, can prevent or slow down the worsening of a condition called atherosclerosis, which is the build-up of fatty plaques in your arteries. This is specifically for people who are receiving a type of cancer treatment called 'immune checkpoint inhibitors'. The study will compare patients taking atorvastatin to those taking a dummy pill (placebo) to see if there's a difference in how these plaques change over one year. Researchers will measure changes in these fatty deposits in the main artery in the chest and in the arteries around the heart, as well as look at overall health and quality of life. Participants will be monitored carefully for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

172

Start

12 May 2025

Atherosclerosis

What is this study about?

This study is called "Statins to Prevent Immune checkpoint inhibitor-induced pRogression of AtheroscLerosis", which is quite a mouthful! In simpler terms, it's looking into whether a common medication called a 'statin' can help prevent or slow down the build-up of fatty deposits in your blood vessels. These fatty deposits are part of a condition called atherosclerosis, sometimes known as 'hardening of the arteries'.

The research is focused on people who are receiving a specific type of cancer treatment. These cancer treatments, called 'immune checkpoint inhibitors', are very effective, but sometimes they can have side effects, and researchers want to see if they might affect the speed at which these fatty deposits develop or get worse. The main goal is to see if taking a statin medication, specifically atorvastatin, can make a difference in how much these fatty deposits change over about a year compared to not taking it.

To figure this out, some patients will take atorvastatin, while others will take a 'placebo' – a dummy pill that looks like the real medicine but doesn't contain any active drug. This allows researchers to fairly compare the two groups. They will carefully measure the amount of fatty deposits in blood vessels, particularly in the main artery in your chest and the arteries around your heart, using special scans. They will also look at other aspects of health, including quality of life and any side effects, to get a full picture of how the medication might help and how it affects patients.

Key takeaways

This study explores if atorvastatin (a statin) helps people on certain cancer treatments.
It aims to see if the medicine slows down the build-up of fatty deposits in blood vessels.
Participants will receive either atorvastatin or a dummy pill.
The study involves monitoring changes in blood vessels and general health over about a year.
It's for adults (18+) of all sexes who are starting specific cancer therapies.

Who may be eligible?

This study is open to both men and women aged 18 years and older. There is no upper age limit for taking part.

Specifically, you would need to be receiving certain cancer treatments called 'immune checkpoint inhibitors'. This study is designed for patients who are already starting or have recently started this type of cancer therapy.

Further specific medical details would be discussed with you by the study team to confirm if the study is a good fit for your health and treatment plan.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently receiving or about to start 'immune checkpoint inhibitor' cancer therapy?
Are you able to attend regular appointments for about one year?
Are you willing to take a daily study medication (either active drug or placebo)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to take a study medication daily. This would either be atorvastatin or a placebo (a dummy pill). You wouldn't know which one you are taking, nor would your study doctor. Over approximately one year, you would have several visits or appointments. These would likely include blood tests, physical examinations, and special scans to measure the fatty deposits in your arteries.

Your quality of life will also be assessed through questionnaires at the start, after 3 months, 6 months, and after one year. The research team will closely monitor you for any side effects or changes in your health throughout the study. The total duration of active participation and follow-up would be about one year.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might benefit from closer monitoring of your health, and if you are taking atorvastatin, it could potentially help slow down or prevent the worsening of atherosclerosis, though this is what the study aims to find out. As with any medication, there's a risk of side effects from atorvastatin, which your study doctor will discuss with you. If you receive the placebo, you won't experience medicinal side effects but also won't receive the potential benefits of atorvastatin. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is atherosclerosis?

Atherosclerosis is when fatty deposits, called plaque, build up inside your arteries, making them narrower and harder. This can restrict blood flow and lead to serious health problems.

What are statins?

Statins are a group of medicines commonly prescribed to help lower cholesterol levels in the blood. They are known to help reduce the risk of heart disease and stroke.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medication but doesn't contain any active drug. It helps researchers compare results fairly to see if the actual medicine is effective.

Why is this study important?

This study is important because it could help us understand if a widely available medicine can protect the heart and blood vessels of people receiving certain cancer treatments, potentially improving their long-term health.

Will I have to pay to participate?

No, you will not have to pay to participate in the study. All study-related medications and procedures will be provided at no cost to you.