AuthorisedTherapeutic use (Phase IV)Interventional

Randomized clinical trial to assess the efficacy and safety of a strategy for primary prevention of cardiovascular disease in patients with inflammatory rheumatic diseases based on the use of carotid ultrasound.

This research trial is for adults with ongoing inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or lupus. We're testing different approved medicines to see how well they can stop serious heart and blood vessel problems, like heart attacks or strokes. The study also investigates if looking at the blood vessels in your neck with an ultrasound scan can help doctors choose the best treatment for you. This is a Phase 4 study, which means we are looking at how existing treatments work in real-world situations for preventing these health issues. The main goal is to see if these approaches can reduce the number of people who experience serious heart-related events or even death due to heart conditions.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Instituto De Investigacion Marques De Valdecilla

Enrolment target

1,250

Start

03 Oct 2025

CHRONIC INFLAMMATORY RHEUMATIC DISEASE: rheumatoid arthritis or psoriatic arthritis or axial spondyloarthritis or systemic lupus erythematosus

What is this study about?

If you have a long-term inflammatory condition, like rheumatoid arthritis or lupus, you might be more likely to develop problems with your heart and blood vessels compared to people without these conditions. This is because the inflammation can affect your whole body, including your arteries.

This study is trying to find the best way to prevent these heart-related problems, like heart attacks and strokes, in people with these conditions. We're looking at different types of medicines that are already used to manage cholesterol or blood pressure. We also want to understand if a special scan of the blood vessels in your neck, called a carotid ultrasound, can help doctors decide which treatment is best for you to keep your heart healthy.

The main aim is to see if these treatments can reduce your risk of having a serious heart event, or even dying from a heart-related illness. We'll also be tracking each type of event separately to get a clearer picture of how each treatment works.

Key takeaways

This study explores new ways to protect the heart in people with inflammatory diseases.
It tests common heart-protecting medicines to see which work best.
A neck ultrasound might help guide treatment decisions for your heart.
The study aims to reduce heart attacks, strokes, and similar serious events.
It's for adults with chronic inflammatory conditions like rheumatoid arthritis or lupus.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. You would be considered for this study if you have a chronic (long-term) inflammatory condition.

Specifically, you need to have one of the following conditions: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (like ankylosing spondylitis), or systemic lupus erythematosus.

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?
Do you have rheumatoid arthritis?
Do you have psoriatic arthritis?
Do you have axial spondyloarthritis (like ankylosing spondylitis)?
Do you have systemic lupus erythematosus?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive one of several approved medications, such as rosuvastatin and ezetimibe, bempedoic acid, or atorvastatin and amlodipine. These are all medicines used to help protect your heart. You would have regular appointments for check-ups and to monitor how you're doing. These visits would likely include blood tests, physical examinations, and possibly ultrasound scans of your neck to watch for any changes in your blood vessels. The study will continue as long as necessary to track how effective the treatments are in preventing heart-related events, meaning the full duration will depend on the overall course of the study.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of receiving treatment that might help protect your heart and blood vessels, potentially lowering your risk of serious events like heart attacks or strokes. However, like all medicines, the treatments used in this study can have side effects, and your doctors will discuss these with you in detail. There is also no guarantee that the treatment 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 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
Spain

Common questions

What kind of inflammatory conditions are included?

This study includes conditions like rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (e.g., ankylosing spondylitis), and systemic lupus erythematosus.

What medicines are being tested?

We are looking at approved medicines like rosuvastatin and ezetimibe, bempedoic acid, and atorvastatin and amlodipine, all used to help protect your heart.

What is a 'carotid ultrasound'?

It's a harmless scan of the main blood vessels in your neck. It helps doctors see if there are any early signs of narrowing or hardening that could lead to heart problems.

What are 'major cardiovascular events'?

These are serious heart-related health issues, such as a heart attack, stroke, severe chest pain needing hospital care, or an operation to improve blood flow to your legs, or death due to heart disease.

Why is this study important?

It aims to find better ways to prevent serious heart and blood vessel problems, which can be more common in people with long-term inflammatory conditions.