Ongoing Clinical Trials for Carotid Arteriosclerosis
Currently, there are 3 ongoing clinical trials exploring different approaches to treating and understanding carotid arteriosclerosis. These studies are investigating advanced imaging techniques, neuroprotective therapies, and medications that may help stabilize arterial plaques. The trials are being conducted in Belgium, Finland, and Denmark, offering opportunities for patients with carotid artery disease, recent stroke, or peripheral artery disease with carotid involvement.
Clinical trial locations
- Belgium
- Denmark
- Finland
Study of [18F]AlF-NOTA-Octreotide for Carotid Artery Disease in Patients with Recent Stroke or TIA
This clinical trial is testing an advanced imaging technique to better identify and measure the severity of carotid artery disease in patients who have recently experienced a stroke or mini-stroke.
Main inclusion criteria: Participants must be over 18 years old and have experienced a recent ischemic stroke or high-risk transient ischemic attack (TIA) in the carotid artery area within the past 21 days. The carotid artery must show at least 30% narrowing. A CT angiography scan must be available as part of routine care, and participants must provide written informed consent.
Main exclusion criteria: The trial has specific exclusion criteria, though detailed information was not provided in the source data. Generally, factors that would prevent safe participation or interfere with imaging results would be considered.
Focus and goals: The study uses a special imaging solution called [18F]AlF-NOTA-Octreotide, which is injected into participants before they undergo a combined PET/MRI scan. This imaging technique helps doctors see the carotid arteries in greater detail, allowing them to characterize and quantify atherosclerotic plaques. The study follows participants for up to three years to see if the initial imaging results can help predict future health events such as another stroke, TIA, or other vascular complications.
Investigational drug: [18F]AlF-NOTA-Octreotide is a radiotracer administered through injection. It works by binding to specific receptors that are often overexpressed in atherosclerotic plaques, making them visible on PET/MRI scans. This helps doctors assess the risk and severity of carotid artery disease.
Study on the Effects of Xenon and Oxygen on Brain Injury and Recovery in Patients with Aneurysmal Subarachnoid Hemorrhage in Intensive Care
This trial investigates whether the gas xenon can help protect the brain and improve recovery in patients who have suffered a specific type of brain bleeding.
Main inclusion criteria: Patients must be at least 18 years old and have an aneurysmal subarachnoid hemorrhage visible on imaging tests (CTA or DSA). They must be intubated and have a deteriorated level of consciousness measured as Hunt-Hess grade 3 to 5, with a Glasgow Coma Scale score of 3 to 12. The xenon treatment must begin within 6 hours of symptom onset. Informed consent must be obtained from next of kin or a legal representative.
Main exclusion criteria: Patients with uncontrolled serious infections, severe heart problems, recent stroke (within 6 months), severe liver or kidney disease, pregnancy or breastfeeding, known allergy to xenon, participation in another clinical trial, mental health conditions that might interfere with the study, or a history of substance abuse are excluded.
Focus and goals: The study explores whether xenon, administered through inhalation, can reduce brain injury and improve neurological outcomes and survival rates in patients with aneurysmal subarachnoid hemorrhage. Participants undergo regular assessments, including MRI scans, to evaluate the condition of their brain, particularly the white matter. The trial includes a follow-up period of up to one year to monitor long-term recovery and assess the safety and tolerability of xenon treatment.
Investigational drug: Xenon is a noble gas administered through inhalation via a ventilator. It is believed to work by blocking certain receptors in the brain involved in cell death, potentially preserving brain function after hemorrhage. It has anesthetic properties and is being studied for its neuroprotective effects.
Study on Rivaroxaban for Stabilizing Carotid Artery Plaques in Patients with Stable Peripheral Artery Disease
This trial examines whether the blood-thinning medication Rivaroxaban can help stabilize fatty plaques in the carotid arteries of patients with peripheral artery disease.
Main inclusion criteria: Participants must be over 18 years old and have been on aspirin therapy for more than 6 months and statin therapy for more than 6 months. They must have asymptomatic carotid stenosis with a hypoechoic carotid plaque at least 2.5 mm thick. Additionally, they must have stable peripheral artery disease, confirmed by previous revascularization procedures, amputation due to arterial insufficiency, or intermittent claudication with specific diagnostic criteria. Written informed consent is required.
Main exclusion criteria: Patients with a history of stroke, transient ischemic attack, or amaurosis fugax (temporary vision loss) are excluded, as are those with unstable medical conditions or inability to comply with study procedures.
Focus and goals: The study observes how Rivaroxaban affects the structure of atherosclerotic plaques in the carotid artery over one year. Using 3D contrast-enhanced ultrasound, researchers monitor whether the plaques become more stable, indicated by changes in their appearance. The trial tracks changes in plaque volume and any blood clots within them, as well as major cardiovascular events such as heart attacks and strokes.
Investigational drug: Rivaroxaban (marketed as Xarelto) is an oral anticoagulant taken as a 2.5 mg tablet. It works by inhibiting a specific protein essential for blood clot formation, helping to prevent clots that could lead to strokes. In this study, researchers are investigating whether it can stabilize carotid plaques and reduce the risk of them breaking apart.
Summary
These three clinical trials represent diverse approaches to understanding and treating carotid arteriosclerosis and related conditions. The trials are geographically distributed across Belgium, Finland, and Denmark, with each study focusing on a different patient population and therapeutic approach.
The Belgian trial focuses on advanced diagnostic imaging using a novel radiotracer in patients with recent stroke or TIA, aiming to better predict future vascular events. The Finnish study takes a neuroprotective approach, investigating whether xenon gas can reduce brain injury in critical care patients with brain hemorrhage. The Danish trial examines whether an existing anticoagulant medication can stabilize arterial plaques in patients who also have peripheral artery disease.
Notably, each trial addresses a different stage or manifestation of vascular disease: acute events (Finland), recent events (Belgium), and chronic stable disease (Denmark). This range of approaches reflects the complexity of treating atherosclerotic disease and the need for interventions at multiple stages of disease progression.
