Study on Carotid Stenosis: Evaluating Evolocumab for Plaque Stabilization and Regression in Patients with Carotid Artery Narrowing

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What is this study about?

This clinical trial is focused on studying carotid stenosis, a condition where the carotid arteries, which supply blood to the brain, become narrowed. The study is investigating the effects of a treatment called evolocumab, also known by its code name AMG145. Evolocumab is administered as a solution for injection and is being tested to see if it can help stabilize and reduce the buildup of plaque in the carotid arteries.

The purpose of the study is to evaluate whether evolocumab, when added to ongoing lipid-lowering therapy (LLT), is more effective than LLT alone in stabilizing and reducing carotid plaque. The study will observe participants over a period of 12 months. At the 6-month mark, researchers will assess whether the plaque has become more stable, meaning it has fewer ulcerations and a more regular shape. By the end of 12 months, the study will check if there is a reduction in the narrowing of the arteries.

Participants in the study will receive either evolocumab or a placebo in addition to their current LLT. The treatment is given through an injection, which can be administered either intravenously (IV) or under the skin (subcutaneously). The study aims to provide insights into the potential benefits of evolocumab for individuals with carotid stenosis, potentially leading to improved treatment options in the future.

1 joining the study

Participation begins after meeting the inclusion criteria, which include having carotid stenosis of at least 50% and LDL-C levels of 100 mg/dL or higher despite maximum lipid-lowering therapy (LLT).

2 initial assessment

An initial assessment is conducted to establish baseline values. This includes imaging tests such as Doppler ultrasound (DUS), magnetic resonance imaging (MRI), or computed tomography (CT) to evaluate the carotid plaque.

3 medication administration

The medication evolocumab is administered. It is provided as a solution for injection in a pre-filled syringe, known as Repatha 140 mg. The administration route is either intravenous (IV) or subcutaneous (SC).

4 ongoing treatment

The treatment with evolocumab is continued alongside the ongoing LLT. The objective is to achieve morphological stabilization of the carotid plaque at 6 months and regression at 12 months.

5 six-month evaluation

At 6 months, an evaluation is conducted to assess the morphological stabilization of the carotid plaque. This involves checking for regression of ulcerations and ‘soft’ components, aiming for a regular plaque morphology with a prevalence of fibrous atheroma.

6 twelve-month evaluation

At 12 months, another evaluation is performed to assess the regression of the carotid plaque. This is defined as a reduction in the extent of stenosis and peak systolic velocity (PSV) by at least 5% compared to baseline values.

7 completion of study

The study is estimated to conclude by March 5, 2025. Final assessments are conducted to determine the overall effectiveness of evolocumab in addition to ongoing LLT.

Who Can Join the Study?

Patients must have carotid stenosis, which means a narrowing of the carotid arteries, on one or both sides, with a blockage of 50% or more.
Patients should not have any symptoms related to carotid stenosis.
Patients must have LDL-C levels of 100 mg/dL or higher. LDL-C stands for low-density lipoprotein cholesterol, often called “bad” cholesterol.
Patients should be on the highest possible dose of LLT, which stands for lipid-lowering therapy, but still have high LDL-C levels.
Both men and women can participate in the study.
Participants should be adults, typically aged 18 years and older.
The study does not include vulnerable populations, which means groups that might need special protection or care.

Who Cannot Join the Study?

Patients who have a known allergy or sensitivity to the study medication or its ingredients cannot participate.
Individuals with a history of severe reactions to similar medications are excluded.
Patients who are currently participating in another clinical trial are not eligible.
Those with a medical condition that the study doctors believe could interfere with the study results cannot join.
Pregnant or breastfeeding women are not allowed to participate.
Individuals who are unable to follow the study procedures or attend the required visits are excluded.
Patients with certain heart conditions that the study doctors consider risky for participation are not eligible.
Individuals with uncontrolled high blood pressure are excluded.
Patients with severe liver or kidney disease cannot participate.
Those who have had a recent major surgery or are planning to have surgery during the study period are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	05.03.2021

Trial locations

Investigated drugs:

Evolocumab

Evolocumab is a medication being studied for its ability to stabilize and reduce carotid plaque. It is used in addition to ongoing lipid-lowering therapy (LLT) to see if it can provide better results than LLT alone. The goal is to see if evolocumab can help make the plaque in the carotid artery more stable and reduce its size over time. This is important because unstable plaque can lead to serious health problems like strokes.

Investigated diseases:

Carotid artery stenosis

Carotid Stenosis – Carotid stenosis is a condition where the carotid arteries, which supply blood to the brain, become narrowed. This narrowing is usually due to the buildup of fatty deposits, known as plaques, on the artery walls. As the condition progresses, the plaques can become unstable and may lead to reduced blood flow to the brain. Over time, this can increase the risk of stroke or transient ischemic attacks. The progression of carotid stenosis can vary, with some individuals experiencing significant narrowing over time, while others may have stable plaques that do not worsen. Regular monitoring is often necessary to assess changes in the condition.

Trial ID:

2024-518566-27-00

Protocol code:

CARUSO

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Carotid Stenosis: Evaluating Evolocumab for Plaque Stabilization and Regression in Patients with Carotid Artery Narrowing

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?