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A study to evaluate the use of tocilizumab in adults with acute ischemic stroke undergoing mechanical clot removal.

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What is this trial about?

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

This study focuses on Acute ischemic stroke, a medical emergency that occurs when a blood vessel supplying the brain is blocked. This research aims to investigate if the drug tocilizumab can help limit the size of the brain damage caused by the stroke. Participants in the study will undergo endovascular thrombectomy, which is a procedure used to remove the blockage in the brain vessel. During or around this procedure, participants will receive either tocilizumab or a placebo through an intravenous infusion, which is a method of delivering fluids directly into a vein.

The placebo used in this study consists of sodium chloride. To evaluate how well the treatments work, the size of the injured area in the brain will be measured using MRI, a medical imaging technique that uses magnets to create detailed pictures of the body. Specifically, the study looks at the growth of the area of dead brain tissue over a period of 72 hours. Other aspects of the study involve monitoring physical health, potential side effects, and changes in certain substances in the blood that relate to inflammation.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment administration
After being selected for the study, an intravenous infusion (medicine delivered through a vein) is provided either before or during endovascular thrombectomy, which is a procedure to remove a blood clot from an artery in the brain.
One group receives tocilizumab at a dose of 8 mg per kilogram of body weight. tocilizumab is the test medication.
Another group receives a placebo, which is a sodium chloride (salt water) solution of 40 ml. the placebo contains no active medicine and is used for comparison.
Step 2
Monitoring and imaging
The size of the infarct (the area of brain tissue damaged by a lack of blood flow) is measured using diffusion weighted imaging, which is a specific type of mri (magnetic resonance imaging) scan.
These measurements are taken to assess infarct growth over a period of 72 hours following the procedure.
Step 3
Follow-up assessments
Various medical assessments are performed to monitor health, including checking for intracranial haemorrhage (bleeding inside the skull), infections, or pneumonia.
Blood tests are conducted to check levels of inflammatory markers and other substances in the blood.
Neurological status and physical function are evaluated using standardized scales to track any changes in disability or overall health.

Who can join the trial?

7 criteria

You must be at least 18 years old at the time you agree to join the study.
You must have experienced an acute ischemic stroke, which is a type of stroke caused by a blood clot blocking an artery in the brain.
You must be selected for emergency endovascular treatment, a medical procedure where doctors use thin tubes to reach and clear a blockage in the blood vessels.
The time from when your stroke symptoms first started (the last time you were known to be well) to when you are assigned to the study must be within 12 hours.
You must have a large vessel occlusion, which means a major blood vessel in the brain is blocked, specifically in the anterior circulation (the front part of the brain's blood supply).
Women who are able to become pregnant must use a highly effective method of contraception, which is a reliable way to prevent pregnancy.
You must be able to provide informed consent, meaning you agree to participate after being fully told about the study, or a legal representative must sign for you if you cannot.

Who cannot join the trial?

13 criteria

Any intracranial haemorrhage, which is bleeding inside the skull, seen during brain scans.
Having previously taken tocilizumab (the study medication) for any reason, including participating in this study before.
Having any reasons that prevent a person from undergoing an MRI (a medical scan that uses strong magnets to take pictures of the body).
Having absent or poor collateral circulation, which means the brain does not have enough backup blood vessels to supply blood to the affected area.
Having thrombocytopenia, which is a low count of platelets (the cells that help blood clot), a count of neutropenia (a low number of white blood cells that fight infection), or elevated liver enzymes (signs of liver irritation or damage).
Having a large core of established infarction, which refers to a large area of brain tissue that has already died due to a lack of blood flow.
Having a systolic blood pressure (the top number) higher than 185 mmHg or a diastolic blood pressure (the bottom number) higher than 110 mmHg, even after receiving standard medical treatment.
A known hypersensitivity, or allergic reaction, to tocilizumab or any of its inactive ingredients such as sucrose, polysorbate 80, or various types of phosphates used to balance the liquid.
Being pregnant, having a positive pregnancy test, or currently breastfeeding.
Having any malignancies (cancer), an ongoing infection, an immunodeficiency (a weakened immune system), or any suspicion of a new, sudden infection.
Having a medical history or scans suggesting the intracranial occlusion (a blockage in a brain blood vessel) is an old problem rather than a new one, or having a dissection (a tear in the blood vessel wall) that makes the procedure unlikely to work.
If the endovascular thrombectomy (a procedure to remove a blood clot from a brain artery using a catheter) has already been successfully finished.
Taking immunosuppressive drugs (medicines that lower the body's ability to fight infection), unless the patient is taking a small dose of prednisolone.

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Aarhus University Hospital
Verified
Aarhus, Denmark
Roskilde University
Responsive
Roskilde, Denmark

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Investigated drugs

Tocilizumab is a medication given through a vein to help reduce the amount of brain tissue damage caused by a stroke by managing the body's inflammatory response.

What is already known about the treatment

Sodium chloride
This substance is a common salt solution administered through an intravenous infusion into the bloodstream. It is widely used in medical practice as a base for many treatments and to help maintain proper fluid and salt levels in the body. This electrolyte solution acts by helping to balance the amount of water and minerals in the body's cells.
Tocilizumab
This medication is given as a liquid through an intravenous infusion directly into a vein. It is an approved medicine used to treat various conditions involving excessive inflammation by targeting specific parts of the immune system. On a molecular level, it works by blocking a protein called interleukin-6, which helps prevent the body from overreacting and causing tissue damage. This drug is classified as an interleukin-6 receptor antagonist.

Investigated diseases

Acute ischemic stroke - This condition occurs when a blood vessel supplying blood to the brain becomes blocked. The interruption of blood flow prevents oxygen and essential nutrients from reaching brain cells. As a result, the affected brain tissue begins to suffer damage. The area of injury can expand over time if the blockage is not resolved. This process leads to the loss of function in the parts of the brain controlled by the damaged area.