AuthorisedTherapeutic use (Phase IV)Interventional

Studio CARUSO (CARotid plaqUe StabilizatiOn and regression with evolocumab): stabilizzazione morfologica e regressione della placca carotidea con evolocumab

The CARUSO study is investigating a medicine called Repatha (evolocumab) to see if it can help improve the health of blood vessels in your neck. These blood vessels, called carotid arteries, can sometimes build up fatty deposits, known as plaques, which can narrow them. The study wants to find out if adding Repatha to your current cholesterol-lowering treatment can make these plaques more stable and even shrink them over 6 to 12 months, compared to just continuing with your usual treatment. This is a Phase IV study, meaning the medicine is already approved for other uses, and this study aims to learn more about its effects on carotid plaques.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Azienda Ospedaliera Ordine Mauriziano Di Torino

Enrolment target

100

Start

29 Jan 2025

carotid stenosis

What is this study about?

This study, called CARUSO, is looking into how a particular medicine, Repatha (evolocumab), might help people who have a condition called carotid stenosis. Carotid stenosis means that the main blood vessels in your neck, which carry blood to your brain, have become narrowed due to a build-up of fatty deposits. These deposits are called plaques, and if they become unstable or grow too large, they can increase the risk of serious health problems.

Researchers want to see if adding Repatha to the cholesterol-lowering medicines you might already be taking can make these plaques more stable and potentially reduce their size. They will compare people who take Repatha alongside their usual treatment with those who continue with their usual treatment only. The study will look at changes in the plaques after 6 and 12 months.

Repatha is already a licensed medicine used to lower cholesterol in people at high risk of heart problems. This particular study is a 'Phase IV' study, which means it's designed to gather more information about the medicine's effects in a wider group of people or for new specific uses, like its impact on carotid plaques.

Key takeaways

The study explores if Repatha can stabilise and shrink neck artery plaques.
It compares Repatha plus usual care to usual care alone.
Repatha is an injectable medicine already approved for cholesterol lowering.
Participation involves regular clinic visits over 12 months.
It aims to understand if Repatha can improve carotid artery health.
Open to adults aged 18 and over with carotid stenosis.

Who may be eligible?

To be able to take part in this study, you would need to be at least 18 years old. Both men and women are welcome to participate.

The most important requirement is that you have been diagnosed with carotid stenosis, which means you have some narrowing in the main blood vessels in your neck. You would also likely be receiving standard treatment for high cholesterol, as the study aims to see if adding Repatha improves on this treatment.

There might be other specific health conditions or medications that would prevent you from joining, but these will be discussed in detail by the study team to ensure the study is safe and suitable for you.

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?
Have you been told you have narrowing in your neck arteries (carotid stenosis)?
Are you currently receiving treatment for high cholesterol?
Are you comfortable with the idea of receiving an injection?
Do you commit to attending regular hospital appointments for 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive Repatha in addition to your current cholesterol-lowering medication, or to continue with your current medication only. Repatha is given as an injection, using a pre-filled syringe.

You would have regular visits to the clinic over a period of 12 months. These visits would likely include physical examinations, blood tests to check your cholesterol levels and other health markers, and imaging scans (like ultrasounds) to monitor your carotid plaques. The study team will explain the exact schedule of visits and what each visit will involve, including how to administer the Repatha if you are in that group. Your health will be monitored closely throughout the study.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a medication that might help stabilise or shrink the plaques in your carotid arteries, which could reduce future health risks. You would also receive close medical monitoring. However, like all medicines, Repatha can have side effects, and injections can sometimes cause discomfort or bruising. There's also no guarantee that Repatha will be effective for you personally. You are completely 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
Italy

Common questions

What is a carotid plaque?

A carotid plaque is a fatty deposit that can build up inside the main blood vessels in your neck (carotid arteries), which carry blood to your brain. This can narrow the artery and affect blood flow.

What is Repatha?

Repatha (evolocumab) is a medicine that helps to lower 'bad' cholesterol (LDL-C) levels in the blood. It's given as an injection.

What does 'stabilisation' of a plaque mean?

Plaque 'stabilisation' means making the fatty deposit in your artery less likely to break off or grow, which can reduce the risk of future problems.

How long will the study last?

The study will follow participants for 12 months to observe the effects of the treatment over time.

Will I know if I'm getting Repatha or not?

This study is 'blinded,' meaning neither you nor your study doctor will know if you are receiving Repatha or the control treatment, to ensure fair results. This will be explained further by the study team.