A randomized placebo-controlled double-blind trial phase II two-arm study to investigate infarct growth over 72 hours assessed with diffusion weighted imaging on MRI after treatment with intravenous tocilizumab or placebo in patients above 18 years of age with acute ischemic stroke undergoing endovascular thrombectomy.
This research study is for people who have recently experienced a severe type of stroke called an acute ischemic stroke. These strokes happen when a blood clot blocks blood flow to the brain, and these patients have also had a procedure to remove the clot. The study aims to find out if a medicine called tocilizumab can help reduce the amount of damage to the brain after a stroke. Participants will either receive tocilizumab or a dummy treatment (placebo) through a drip. Doctors will use special brain scans (MRI) to measure changes in stroke damage over 72 hours. This is a Phase II study, meaning researchers are carefully exploring if the treatment is safe and effective in a smaller group of people.
At a glance
What is this study about?
This study is designed for individuals who have recently had a specific type of stroke called an acute ischemic stroke. This happens when a blood clot blocks blood flow to part of the brain. These patients have already had an important procedure called endovascular thrombectomy, which uses a special tool to remove the clot and restore blood flow.
The main goal of this study is to see if a medication called tocilizumab can help protect the brain and limit the amount of additional damage that might happen in the first three days after the stroke, even after the clot has been removed. Researchers will compare tocilizumab to a 'placebo', which is an inactive substance that looks just like the real medicine. This helps them understand if any changes they see are truly due to the study drug or if they would have happened anyway.
To measure the stroke damage, doctors will use special brain scans called MRI. They will carefully look at the size of the damaged area in the brain over 72 hours. They will also collect information on how patients are feeling, their recovery, and look for any changes in certain markers in their blood. The hope is that tocilizumab could help improve outcomes for stroke patients by reducing the long-term impact of the stroke.
Key takeaways
- This study investigates a new treatment (tocilizumab) for severe strokes.
- It aims to see if the treatment can limit brain damage after a stroke.
- Participants will have had a stroke caused by a clot and a clot removal procedure.
- Brain scans (MRI) will measure the impact of the treatment.
- The study compares the new drug to a dummy treatment (placebo).
- It's exploring early safety and effectiveness (Phase II).
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
Importantly, you must have recently had an acute ischemic stroke, which means a stroke caused by a blood clot blocking blood flow to your brain. You also need to have undergone a procedure called endovascular thrombectomy, where doctors removed the blood clot.
Specific medical details will be checked by the study doctors to make sure the treatment is safe and appropriate for you. They will review your medical history and current health to determine if you meet all the necessary requirements for participation.
- Are you 18 years old or older?
- Have you recently had a stroke caused by a blood clot (ischemic stroke)?
- Have you had a procedure to remove that blood clot (endovascular thrombectomy)?
- Are you able to undergo MRI scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive either the study medicine, tocilizumab, or a placebo (dummy treatment) through a drip into your arm. Neither you nor your study doctor will know which one you are receiving – this is known as a 'blinded' study.
You will have several brain scans using an MRI machine to measure the size of the stroke damage. These scans will happen at different times over the first 72 hours after your treatment. The study team will also closely monitor your health, take blood samples, and ask you questions about how you are feeling and your recovery at various points. They will check for any side effects and track your progress. The exact number of visits and tests will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Norway
Common questions
What is an acute ischemic stroke?
It's a common type of stroke caused by a blood clot blocking blood flow to part of your brain.
What is endovascular thrombectomy?
It's a procedure where doctors remove a blood clot from your brain using special tools to restore blood flow.
What does 'placebo-controlled' mean?
It means some people get the study medicine, and others get a dummy treatment that looks the same, so doctors can accurately compare the effects.
What is a 'Phase II' study?
This phase means researchers are carefully testing a new treatment on a smaller group of people to see if it's safe and if it shows promising results.
Will I know if I'm getting the real medicine or the dummy treatment?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.