Ongoing Clinical Trials for Carotid Artery Stenosis
Currently, there are 3 ongoing clinical trials investigating new approaches to managing carotid artery stenosis, a condition where the main blood vessels supplying the brain become narrowed. These trials are taking place across Europe, testing different medications including cholesterol-lowering drugs and anti-inflammatory treatments to prevent complications and improve outcomes for patients with this condition.
Clinical trial locations
- Finland
- Italy
- Netherlands
Study on the Effects of Xenon and Oxygen on Brain Injury and Recovery in Patients with Aneurysmal Subarachnoid Hemorrhage in Intensive Care
This trial is being conducted in Finland and focuses on patients who have experienced aneurysmal subarachnoid hemorrhage, a serious type of brain bleed that occurs when a blood vessel on the brain’s surface bursts. The study investigates whether the gas xenon, delivered through inhalation, can help protect the brain and improve recovery after such an event.
Who can participate: Adults aged 18 and older who have aneurysmal subarachnoid hemorrhage confirmed by imaging tests, with a deteriorated level of consciousness rated as Hunt-Hess grade 3 to 5, and who are intubated. The xenon treatment must be able to start within 6 hours of symptom onset. Informed consent must be obtained from a family member or legal representative since patients are typically unable to provide consent themselves due to their condition.
Who cannot participate: Patients with uncontrolled serious infections, severe heart, liver, or kidney problems, recent stroke within the past 6 months, known allergy to xenon, those who are pregnant or breastfeeding, individuals participating in another clinical trial, or those with mental health conditions or history of substance abuse that might interfere with the study.
Study focus: The trial aims to explore whether xenon can reduce brain injury and improve neurological outcomes and survival rates. Participants will be monitored through MRI scans and other assessments to evaluate changes in the brain’s white matter and overall condition. The study includes a follow-up period of up to one year to assess long-term effects on recovery and quality of life.
Investigational drug: Xenon is administered as an inhaled gas. It is thought to work by blocking certain brain receptors involved in cell death, potentially providing neuroprotective effects after brain hemorrhage.
Study on Carotid Stenosis: Evaluating Evolocumab for Plaque Stabilization and Regression in Patients with Carotid Artery Narrowing
This trial, taking place in Italy, investigates the effects of evolocumab on patients with narrowed carotid arteries. The study seeks to determine whether this medication can help stabilize and reduce plaque buildup in the arteries when added to existing cholesterol-lowering treatment.
Who can participate: Adults with narrowing of at least 50% in one or both carotid arteries who have no symptoms related to this condition. Participants must have LDL cholesterol levels of 100 mg/dL or higher despite being on the highest possible dose of lipid-lowering therapy.
Who cannot participate: Individuals with known allergies to the study medication, those currently participating in another clinical trial, pregnant or breastfeeding women, people with certain medical conditions that could interfere with study results, those unable to follow study procedures, patients with certain heart conditions considered risky, individuals with uncontrolled high blood pressure, those with severe liver or kidney disease, or people who have recently had major surgery or are planning surgery during the study period.
Study focus: The trial evaluates whether evolocumab, administered as an injection either intravenously or under the skin, can make plaques more stable by 6 months and reduce the degree of narrowing by 12 months. Regular imaging tests using Doppler ultrasound, MRI, or CT scans will monitor changes in the carotid arteries throughout the study.
Investigational drug: Evolocumab works by inhibiting a protein called PCSK9, which increases the liver’s ability to remove LDL cholesterol from the blood. The medication is provided as Repatha 140 mg in a pre-filled syringe.
Study on the Effects of Omalizumab on Carotid Artery Stenosis in Patients Undergoing Carotid Endarterectomy
Conducted in the Netherlands, this trial examines whether omalizumab can reduce inflammation in atherosclerotic plaques in patients scheduled for surgical removal of plaque from the carotid artery.
Who can participate: Adults aged 18 and older who are able and willing to provide informed consent, have at least 50% narrowing of the carotid artery, and are scheduled to undergo carotid endarterectomy, a surgical procedure to remove plaque buildup.
Who cannot participate: While specific exclusion criteria details are limited, patients who do not meet the age requirements or other specified criteria will not be eligible.
Study focus: The study investigates whether a short course of omalizumab can reduce the activation of mast cells, which are immune cells that play a role in inflammation and allergic reactions within atherosclerotic plaques. Researchers will monitor various health parameters including immune cell levels, proteins in the blood, inflammation markers, and plaque characteristics to evaluate the medication’s effects.
Investigational drug: Omalizumab, marketed as Xolair, is a monoclonal antibody administered as an intramuscular injection in a 150 mg pre-filled syringe. It works by binding to immunoglobulin E antibodies, preventing them from attaching to mast cells and basophils, thereby reducing allergic responses and inflammation.
Summary
These three clinical trials represent diverse approaches to addressing complications related to narrowed carotid arteries across different European countries. While one trial focuses on brain protection following hemorrhage using an innovative gas therapy in Finland, the other two trials in Italy and the Netherlands target the plaques themselves through different mechanisms. The Italian study investigates cholesterol management using a PCSK9 inhibitor, while the Dutch study explores anti-inflammatory approaches targeting immune cell activity. Each trial emphasizes careful patient selection based on the severity of arterial narrowing and existing treatments, with monitoring periods ranging from 6 to 12 months to assess both safety and effectiveness of these interventions.
