Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

GREEN A randomized, double-blind, multi-center, placebo-controlled, efficacity and safety study of glenzocimab used as an add-on therapy on top of mechanical thrombectomy for acute ischemic stroke

The GREEN study is looking into a new medicine called glenzocimab for people who have recently had a stroke. This study is being done in several hospitals and is comparing glenzocimab to a dummy treatment (placebo) to see if it improves recovery when given alongside standard stroke treatment. Researchers are particularly interested in how well patients can carry out daily activities 90 days after their stroke. They are also checking for any side effects or problems. This is an important step in finding better ways to help people recover from strokes. It’s for adults of all ages and both men and women. The study will help us understand if glenzocimab can improve the lives of stroke survivors.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

260

Start

07 Oct 2024

Acute ischemic stroke

What is this study about?

When someone has a certain type of stroke, called an acute ischemic stroke, it means a blood clot is blocking blood flow to part of their brain. Doctors often use a procedure called mechanical thrombectomy to remove this clot. The GREEN study is testing a new medicine, glenzocimab, to see if giving it to patients shortly after this procedure can help them recover even better.

Imagine the study like this: some patients will receive glenzocimab along with their usual treatment, while others will receive a dummy medicine (a placebo) that looks just like glenzocimab but has no active ingredients. Neither the patients nor their doctors will know who is getting which treatment until the study is over. This helps make sure the results are fair and accurate. The main goal is to see if patients who received glenzocimab are able to do more things for themselves, like walk or get dressed, 90 days after their stroke, compared to those who received the dummy medicine.

Researchers will also be looking at many other things. For example, they'll check how quickly the blood flow is restored to the brain, if there's any new brain damage, and how patients feel about their quality of life. Safety is also a top priority, so they'll be closely monitoring for any side effects or concerns, especially any bleeding in the brain, throughout the study.

Key takeaways

The GREEN study is testing a new drug, glenzocimab, for stroke patients.
It's being given alongside standard clot-removing treatment.
The main goal is to see if it helps patients recover better everyday activities.
Safety is a top priority, with close monitoring for side effects.
Some participants will receive glenzocimab, others an inactive dummy treatment (placebo).

Who may be eligible?

This study is looking for adults who have recently had a specific type of stroke called an acute ischemic stroke. This means the stroke was caused by a blood clot blocking blood flow to the brain.

To be considered for the study, you must be 18 years old or older. The study is open to both men and women. There might be some other specific health conditions or treatments that would mean you couldn't join the study, but the doctors at the study site will check all of this carefully.

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 blood clot (acute ischemic stroke)?
Are you able to agree to take part in the study?
Are you comfortable with ongoing monitoring and follow-up appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you join the GREEN study, you would receive either the study drug, glenzocimab, or a dummy medicine (placebo), usually given through a drip, shortly after your stroke treatment. You will have regular check-ups with the study team. These check-ups will involve doctors asking about your health and how you are feeling, as well as some physical examinations. You might also have blood tests and brain scans (like an MRI or CT scan) to see how your brain is recovering.

There will be several follow-up visits, both in person and possibly by phone, over a period of about a year after your stroke. These visits will help the doctors track your recovery, look at how well you're doing everyday activities, and monitor for any side effects. The total duration of your participation in the study will be approximately 1 year, though the most intensive follow-up will be in the first few months.

Potential risks and benefits

Participating in this study might offer a potential benefit if glenzocimab helps improve recovery from stroke, though this is not guaranteed as it's still being tested. There are potential risks, just like with any new medicine, including side effects or unexpected reactions, particularly bleeding, which will be carefully monitored. You will have a dedicated medical team looking after you throughout the study. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 is an acute ischemic stroke?

It's a common type of stroke caused by a blood clot blocking blood flow to part of the brain. Quick treatment is important.

What does 'add-on therapy' mean?

It means glenzocimab is given in addition to standard stroke treatments, not instead of them. It's meant to boost the effect of current treatments.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the study drug but contains no active medicine. It helps researchers compare the real drug's effects accurately.

What is 'functional outcome'?

This refers to how well you can perform daily activities and live independently after your stroke. This is a key measure of recovery in the study.

How long will I be in the study?

You'll be followed closely for about a year to see how you recover and to check for any long-term effects of the treatment.