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Study on Rivaroxaban for Stabilizing Carotid Artery Plaques in Patients with Stable Peripheral Artery Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Rivaroxaban on a condition known as atherosclerosis, which involves the buildup of fatty deposits in the arteries. Specifically, the study looks at patients with stable peripheral artery disease and asymptomatic atherosclerotic plaque or narrowing in the carotid artery. These patients do not show symptoms related to brain blood flow issues, such as stroke or temporary vision loss.

The purpose of the study is to observe how Rivaroxaban affects the structure of atherosclerotic plaques in the carotid artery over time. This will be evaluated using a special imaging technique called 3D contrast-enhanced ultrasound, which helps visualize the plaques. Participants in the study will receive either Rivaroxaban or a placebo for a period of one year. The study aims to determine if the plaques become more stable, as indicated by changes in their appearance on ultrasound images.

Throughout the study, researchers will monitor changes in the volume of the plaques and any blood clots within them. They will also track major health events such as heart attacks, strokes, and other serious cardiovascular issues. The study is designed to provide valuable insights into the potential benefits of Rivaroxaban for patients with atherosclerosis in the carotid artery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will provide oral and written consent to participate. This confirms your understanding and agreement to be part of the clinical trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are over 18 years old, have been on acetylsalic acid (aspirin) therapy for more than 6 months, and have been on statin therapy for more than 6 months.
Your medical history will be reviewed to ensure you have asymptomatic carotid stenosis and a hypoechoic carotid plaque with a thickness of at least 2.5 mm. Additionally, stable peripheral artery disease (PAD) will be confirmed through previous medical procedures or conditions.
Step 3
Medication administration
You will begin taking rivaroxaban, which is provided as Xarelto 2.5 mg film-coated tablets. This medication is taken orally.
The dosage is 2.5 mg, and it will be administered as per the study protocol. The duration of this treatment is planned for one year.
Step 4
Regular monitoring
Throughout the trial, regular monitoring will be conducted to observe the effect of rivaroxaban on the atherosclerotic plaque in your carotid artery.
This will involve 3D contrast-enhanced ultrasound (CEUS) to evaluate changes in plaque morphology over time.
Step 5
End of treatment evaluation
At the end of the one-year treatment period, a final evaluation will be conducted to assess the primary endpoint, which is the stabilization of carotid plaques.
The evaluation will include measuring changes in plaque echogenicity and other secondary endpoints such as volume and thrombus volume.

Who can join the trial?

10 criteria

Provide oral and written informed consent. This means you agree to participate after understanding the study details.
Be an adult over 18 years of age.
Have been on aspirin therapy for more than 6 months. Aspirin is a medication used to reduce pain, fever, or inflammation.
Have been on statin therapy for more than 6 months. Statins are drugs that help lower cholesterol levels in the blood.
Have asymptomatic carotid stenosis. This means there is a narrowing in the carotid artery without causing symptoms.
Have a hypoechoic carotid plaque with a thickness of at least 2.5 mm. This refers to a specific type of buildup in the artery that appears darker on an ultrasound.
Have stable peripheral artery disease (PAD), which is defined as at least one of the following:
- Previous revascularization procedures like aorta-femoral bypass, infrainguinal bypass, thrombendarterectomy, thrombectomy, endovascular procedures, or treatment with heparin and/or thrombolysis. These are medical procedures to restore blood flow.
- Previous amputation of foot or leg due to arterial insufficiency. This means part of the limb was removed because of poor blood flow.
- Current or previous intermittent claudication with one or more of the following:
  - An ankle/brachial index (ABI) less than 0.9. This is a test that compares the blood pressure in your ankle with the blood pressure in your arm.
  - Significant peripheral arterial stenosis greater than 50% verified by angiography or duplex ultrasound. This means a narrowing of the arteries in the limbs confirmed by imaging tests.

Who cannot join the trial?

5 criteria

Patients with a history of **stroke** (a medical condition where blood flow to the brain is interrupted).
Patients who have experienced a **transient ischaemic attack (TIA)**, which is a temporary period of symptoms similar to those of a stroke.
Patients with **amaurosis fugax**, a temporary loss of vision in one eye due to a lack of blood flow to the retina.
Patients with unstable medical conditions that could interfere with the study.
Patients who are unable to comply with the study procedures.

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Rigshospitalet
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Copenhagen, Denmark

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Investigated drugs

Rivaroxaban is a medication used in this clinical trial to help stabilize atherosclerotic plaques in the carotid arteries. These plaques can be dangerous because they might lead to strokes if they break apart. Rivaroxaban works by thinning the blood, which can help prevent clots from forming. In this study, researchers are using a special type of ultrasound to see if Rivaroxaban can change the shape or size of these plaques over time, making them less likely to cause problems.

Rivaroxaban

What is already known about the treatment

Rivaroxaban – Rivaroxaban is a medication taken orally, usually in the form of a tablet. It is currently being studied for its effects on stabilizing atherosclerotic plaques in the carotid artery, which are fatty deposits that can lead to serious conditions like strokes. The main therapeutic use of Rivaroxaban is to prevent blood clots, and it works by inhibiting a specific protein in the blood that is essential for clot formation. This medication is classified as an anticoagulant, which means it helps to keep the blood flowing smoothly by preventing clots from forming.

Investigated diseases

Peripheral Artery Disease
Peripheral artery disease is a condition where the arteries that supply blood to the limbs, usually the legs, become narrowed or blocked due to a buildup of fatty deposits. This narrowing reduces blood flow, which can lead to symptoms such as leg pain when walking, known as claudication. Over time, the reduced blood flow can cause the affected limb to feel cold or weak. In some cases, the skin on the limb may change color or develop sores that do not heal. The disease progresses slowly and can lead to more severe complications if the blood flow becomes significantly restricted.
Atherosclerosis
Atherosclerosis is a condition characterized by the buildup of fatty deposits, cholesterol, and other substances in and on the artery walls, forming plaques. These plaques can harden and narrow the arteries, limiting the flow of oxygen-rich blood to organs and other parts of the body. As the disease progresses, the plaques can rupture, leading to the formation of blood clots. This can further obstruct blood flow or break off and travel to other parts of the body, potentially causing serious complications. The progression of atherosclerosis is gradual and can affect any artery in the body, including those in the heart, brain, arms, legs, and kidneys.
Carotid Artery Stenosis
Carotid artery stenosis is a condition where the carotid arteries, which supply blood to the brain, become narrowed due to atherosclerosis. This narrowing can reduce blood flow to the brain and increase the risk of stroke. As the condition progresses, the risk of a plaque breaking off and causing a blockage in a smaller artery in the brain increases. The disease may remain asymptomatic for a long time, but it can lead to transient ischemic attacks or strokes if the blood flow is significantly reduced. The progression of carotid artery stenosis can vary, and it often requires monitoring to prevent complications.