Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Glenzocimab in Anterior stroke with Large Ischemic Core eligible for Endovascular therapy

This study is investigating a new medication called Glenzocimab, designed for people who have experienced a severe type of stroke. This kind of stroke happens when a large blood clot blocks an artery in the brain. Alongside the usual emergency procedure to remove the clot, researchers want to see if adding Glenzocimab can help improve recovery. They will check how well people are doing three months after their stroke, using a special scale to measure their ability to go about daily life. The study also looks at how safe the drug is and if it reduces problems like further bleeding in the brain. This is an early-stage study to understand the drug better.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hopital Fondation Adolphe De Rothschild

Enrolment target

304

Start

22 May 2024

Ischemic stroke with Large Core

What is this study about?

This study is about an important medical condition called an ischaemic stroke, which happens when a blood clot blocks blood flow to part of the brain. When this blockage is large and causes a lot of damage, it's called a 'large core' stroke. Currently, a common treatment for these severe strokes is an emergency procedure to physically remove the clot, called endovascular therapy.

Researchers want to find out if adding a new drug, called Glenzocimab, to this standard clot-removing treatment can help people recover better. They believe Glenzocimab might help protect the brain or reduce further damage. The main thing they'll be looking at is how well people are recovering three months after their stroke. This will be measured using a special scale that assesses how able someone is to do everyday activities.

They will also be checking for other important things, like how many people experience a good recovery, how common any side effects are, especially bleeding in the brain, and how well the blood flow is restored after the clot removal. This is a 'Phase II' study, which means it's an early stage of research to see if the treatment is safe and shows promising signs of working before larger studies are carried out.

Key takeaways

The study explores a new drug (Glenzocimab) for severe stroke.
It aims to improve recovery after a large stroke caused by a clot, alongside standard treatments.
The main goal is to see how well people are doing three months post-stroke.
It's an early-stage study to evaluate safety and potential benefits.
You'll be carefully monitored throughout your participation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older, who has recently had a specific type of severe stroke caused by a large blood clot. Both men and women are welcome to participate.

There will be specific medical criteria that doctors will check to make sure the study is right and safe for you. These criteria are based on detailed scans of your brain and other health information that only a doctor can properly assess.

It's important to remember that not everyone who has had a stroke will be able to join. The doctors running the study will carefully review each potential participant to ensure they meet all the necessary requirements for safety and to make sure the study results are as clear and accurate as possible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a stroke caused by a large blood clot?
Are you able to undergo standard clot removal treatment?
Are you available for follow-up assessments at three months?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive the study drug, Glenzocimab, or a dummy drug (placebo) or a control solution, along with the standard procedure to remove your blood clot. You would have several hospital visits and assessments, including brain scans and blood tests, to monitor your health and the effects of the treatment. Doctors and nurses will check you regularly in the hospital after your stroke. There will be follow-up phone calls from trained professionals at three months after your stroke to assess your recovery and how you are doing in your daily life. The study aims to follow participants for a specific period to understand long-term effects, with the main assessment at three months. The total duration of your active involvement in the study will mostly revolve around your initial hospital stay and then a follow-up three months later.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new treatment that could improve your recovery after a severe stroke, although there's no guarantee the investigational drug will work for you. There are potential risks associated with any medical study, including side effects from the medication or the procedures involved. The study team will carefully monitor you for any problems. You will be fully informed about all known risks before deciding to join, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What kind of stroke is this study for?

This study is for people who have had a severe stroke caused by a large blood clot that blocks blood flow in the brain.

What is Glenzocimab?

Glenzocimab is a new investigational drug that researchers are hoping could help improve recovery after a severe stroke.

Will I know if I'm getting the new drug?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving Glenzocimab or the comparison treatment to keep the results fair.

How will my recovery be checked?

Your recovery will mainly be checked by a phone call three months after your stroke, where trained professionals will ask about your ability to do daily activities.

Can I stop participating in the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and this won't affect the care you receive for your stroke.