Stabilization of vulnerable atherosclerotic carotid plaques by Rivaroxaban as evaluated by 3D contrast enhanced ultrasound (CEUS)
This research trial is investigating whether a common blood-thinning medication, rivaroxaban (also known as Xarelto), can help make dangerous plaques in the neck's carotid arteries more stable. These plaques are fatty deposits that can build up and potentially cause strokes. The study focuses on people who already have stable peripheral artery disease – a condition affecting circulation in the limbs – and who have these plaques in their neck arteries but haven't had a stroke or mini-stroke from them. Researchers will use special 3D ultrasound scans to see if taking a small dose of rivaroxaban for a year changes the plaques, making them less ‘active’ or prone to causing problems, compared to a dummy pill (placebo). They will also track serious health events like heart attacks, strokes, and limb problems.
At a glance
What is this study about?
This study is about understanding how a medicine called rivaroxaban might help people who have a condition where fatty deposits, known as ‘plaques’, build up in their carotid arteries. These are important blood vessels in your neck that supply blood to your brain. If these plaques are unstable, parts of them can break off and travel to the brain, potentially causing a stroke or a mini-stroke (TIA).
The researchers want to see if a low dose of rivaroxaban, a medicine already used to prevent blood clots, can make these plaques more stable and less likely to cause problems. They are focusing on people who have a condition affecting their circulation in other parts of the body (called peripheral artery disease) and also have these carotid artery plaques, but haven't yet had any stroke-related symptoms from them.
To do this, participants will either take rivaroxaban or a placebo (a dummy pill) for a year. The main way they will check the plaques is by using special, advanced 3D ultrasound scans. These scans will help them see if the plaques change over time, becoming more 'stable'. They will also carefully monitor participants for any major health events, including strokes, heart attacks, or serious issues with their limbs.
Key takeaways
- Tests if rivaroxaban can stabilise neck artery plaques.
- Aims to prevent strokes and other heart-related problems.
- Includes people with existing peripheral artery disease.
- Uses advanced ultrasound scans to monitor plaques.
- Participants take medication (or placebo) for one year.
- Researchers will also track serious health events.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or over. Both men and women are welcome to take part.
An important requirement is that you must have a diagnosed condition called 'stable peripheral artery disease'. This means you have ongoing circulation problems in your limbs, but your condition is not rapidly getting worse.
Finally, you must also have fatty plaques in the carotid arteries in your neck. However, these plaques must not have caused you any stroke-like symptoms, such as a full stroke, a mini-stroke (TIA), or temporary blindness in one eye (amaurosis fugax). The study is for people whose plaques are currently considered 'asymptomatic'.
- Are you 18 years old or older?
- Have you been diagnosed with 'stable peripheral artery disease'?
- Do you have fatty plaques in your neck arteries?
- Have these neck artery plaques *not* caused you any stroke, mini-stroke (TIA), or temporary blindness?
- Are you willing to take a study tablet daily for one year?
- Are you able to attend regular clinic visits and ultrasound scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will be given either a daily film-coated tablet of rivaroxaban (2.5 mg) or a placebo (a dummy pill that looks the same but contains no active medicine). You won't know which one you're taking, and neither will your doctor, to ensure the results are unbiased.
You'll need to attend several clinic visits over a period of one year. At these visits, you'll have specific blood tests and a special type of 3D ultrasound scan called CEUS (contrast-enhanced ultrasound) of your neck arteries. These scans help the doctors look closely at the plaques. You will be monitored throughout the year for any changes in your health, including any serious events like strokes or heart attacks. After the one-year treatment period, there will be follow-up observations.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What are carotid plaques?
Carotid plaques are fatty deposits that can build up in the arteries in your neck, which supply blood to your brain. They can sometimes lead to strokes.
What is rivaroxaban (Xarelto)?
Rivaroxaban is a medicine often used to prevent blood clots. In this study, a low dose is being tested to see if it can help stabilise plaques.
What is 'peripheral artery disease'?
This is a condition where narrowed arteries reduce blood flow to your limbs, usually your legs, causing symptoms like pain when walking.
Will I know if I'm taking the real medicine or a dummy pill?
No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're taking rivaroxaban or the placebo. This helps ensure unbiased results.
How long will I be in the study?
You'll be taking the study medicine for one year, with regular check-ups and scans during that time and possibly further follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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