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Study on Glenzocimab for Patients with Large Ischemic Stroke Eligible for Endovascular Therapy

Fast replyRegistered drugNo placebo

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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 a condition known as ischemic stroke, which occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow. The study is specifically looking at patients with a large area of brain damage, referred to as a large ischemic core, who are eligible for a procedure called endovascular therapy (EVT). This therapy involves using a catheter to remove the clot and restore blood flow. The trial will test a treatment called Glenzocimab, which is given as a solution through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. Glenzocimab is being compared to a placebo to see if it can improve the chances of a good recovery three months after the stroke.

In addition to Glenzocimab, the study involves the use of GADOVIST, a contrast agent used in imaging tests to help visualize blood vessels and tissues more clearly. This agent is administered through an intravenous injection. The trial will also use a 0.9% sodium chloride solution, which is a common fluid used in medical settings. The main goal of the study is to determine if Glenzocimab can help patients achieve better functional outcomes, which means being able to perform daily activities more independently, three months after their stroke.

Participants in the study will receive either Glenzocimab or a placebo, and their progress will be monitored over a period of three months. The study will assess various outcomes, including the presence of any bleeding in the brain, the overall recovery of brain function, and the rate of survival. The trial aims to provide valuable information on whether Glenzocimab can be an effective treatment option for patients with ischemic stroke and a large ischemic core, potentially improving their quality of life after the stroke.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, type of stroke, and medical history.
Consent is obtained either from the patient or a family member if the patient is unable to provide it.
Step 2
Initial assessment
An initial assessment is conducted, including imaging tests like MRI or CT scans to evaluate the stroke's impact.
A pregnancy test is required for women of childbearing age.
Step 3
Treatment administration
The treatment involves an intravenous infusion of glenzocimab or a placebo.
The infusion is administered through a vein, using a solution for infusion.
Step 4
Endovascular therapy (EVT)
Eligible patients undergo EVT, a procedure to remove the blockage in the blood vessel.
This procedure is performed within a specific time window after the stroke onset.
Step 5
Post-treatment monitoring
Monitoring includes imaging tests to assess the brain's condition and detect any complications.
A brain CT scan is performed 24-36 hours after EVT to check for bleeding.
Step 6
Follow-up assessments
Functional outcomes are evaluated at 3 months using the modified Rankin Scale, a measure of disability.
Additional assessments may include cognitive tests and evaluations of neurological improvement.
Step 7
Long-term follow-up
Further assessments are conducted at 12 months to evaluate long-term outcomes.
These assessments include functional and cognitive evaluations, as well as monitoring for any adverse events.

Who can join the trial?

7 criteria

Must be older than 18 years.
Have an acute ischemic stroke caused by a blockage in a large blood vessel in the brain. This includes specific areas like the M1 and M2 segments of the middle cerebral artery or the terminal internal carotid artery.
Eligible for a procedure called EVT (Endovascular Therapy) within 0 to 24 hours, whether or not they have received a treatment called intravenous thrombolysis.
Have a certain size of the affected brain area, which is checked using an MRI or CT scan. The scan should show an ASPECTS score of less than 6. ASPECTS is a way to measure the extent of the stroke on a scan.
Women who can have children must have a negative pregnancy test at the start of the study.
Must have social security or health insurance.
Must provide informed consent to participate. This means the patient agrees to join the study after understanding what it involves. If the patient cannot give consent due to their condition, a family member or trusted person can do it for them. If no one is available, the patient can still join, and consent will be obtained as soon as possible.

Who cannot join the trial?

8 criteria

Patients who have had a recent **ischemic stroke** with a **large core**. An ischemic stroke happens when a blood clot blocks a blood vessel in the brain, and a large core means a significant area of the brain is affected.
Patients who are not eligible for **endovascular therapy (EVT)**. EVT is a treatment that involves removing a blood clot from a blood vessel in the brain.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to give informed consent or understand the study requirements.
Patients who have other medical conditions that might interfere with the study or its results.
Patients who are currently participating in another clinical trial.
Patients who have allergies or reactions to the study medication or similar drugs.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Verified
Centre Hospitalier Regional Universitaire De Tours
Tours, France

Trial locations

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Investigated drugs

Glenzocimab is a medication being studied for its potential to improve outcomes in patients who have had a type of stroke called an anterior stroke with a large ischemic core. This medication is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The goal of using glenzocimab in this trial is to see if it can help patients achieve better functional outcomes three months after their stroke, especially those who are eligible for a procedure called endovascular therapy.

What is already known about the treatment

Glenzocimab – Glenzocimab is administered through intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating ischemic stroke with a large core. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for glenzocimab is to improve functional outcomes in patients who have experienced an ischemic stroke and are eligible for endovascular therapy. At the molecular level, glenzocimab works by inhibiting platelet aggregation, which helps to prevent further clot formation and improve blood flow. It is classified pharmacologically as an antiplatelet agent.

Investigated diseases

Ischemic Stroke with Large Core – This condition occurs when a blood clot blocks a blood vessel in the brain, leading to a significant area of brain tissue being deprived of blood and oxygen. The "large core" refers to a substantial area of the brain that has already been damaged by the lack of blood flow. As the stroke progresses, the affected brain tissue can swell, potentially leading to further complications. Patients may experience a range of symptoms, including weakness, difficulty speaking, and loss of coordination, depending on the area of the brain affected. The progression of the disease can vary, with some individuals experiencing improvement over time, while others may have lasting impairments.