Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

CHemical OptImization of Cerebral Embolectomy in patients with acute stroke treated with mechanical thrombectomy 2 (CHOICE2TRIAL)

The CHOICE2TRIAL study is investigating the effects of a medicine called Actilyse in people who have had a severe type of stroke. These patients have already had an urgent procedure to remove a blood clot from their brain. The study aims to see if giving Actilyse after this procedure can help more people make a good recovery and reduce the amount of brain tissue that is damaged. Researchers will be looking at how well people recover their daily activities and their overall quality of life three months after the stroke. They will also use special brain scans to see if the medicine helps protect the brain from further damage.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Foundation Clinic For Biomedical Research

Enrolment target

440

Start

19 Oct 2023

Cerebral Embolectomy in patients with acute stroke

What is this study about?

Imagine your brain is like a complex city, and the blood vessels are the roads delivering supplies. A stroke happens when one of these roads gets blocked by a clot, cutting off vital oxygen and nutrients to parts of the brain. This can cause various problems, from difficulty speaking or moving to more severe issues.

Doctors often perform an urgent procedure called a 'mechanical thrombectomy' to remove the clot, like clearing a blocked road. This study, CHOICE2TRIAL, is looking at whether giving a common clot-busting medicine, Actilyse, immediately after this procedure can further improve how well people recover. Actilyse is already used to dissolve blood clots, but we want to see if it makes a difference when given after the main clot has been mechanically removed.

The main goal is to find out if more people can return to their daily lives largely unaffected by the stroke three months later. We're also checking if this medicine can help to limit the amount of brain tissue that's damaged and improve a person's overall quality of life after such a serious event.

Key takeaways

Targets severe stroke patients after clot removal.
Tests if Actilyse improves recovery and reduces brain damage.
Focuses on recovery of daily activities and quality of life.
Includes special brain scans to monitor effects.
Follow-up for about three months.

Who may be eligible?

This study is for adults who have recently had a specific type of severe stroke. To be considered, you must have just undergone an urgent procedure to remove a blood clot from your brain. This procedure is called a mechanical thrombectomy.

There are some other medical conditions or situations that might prevent someone from joining the study, even if they meet the main criteria. For instance, if you have certain other serious health issues, or if it's been too long since your stroke happened. The medical team will check this carefully.

Both men and women aged 18 and over are welcome to take part.

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 severe stroke caused by a blood clot?
Have you just undergone a procedure to remove that blood clot (mechanical thrombectomy)?
Are you able to participate in follow-up assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the study medicine (Actilyse) or a placebo (a dummy medicine) after your clot removal procedure. You won't know which one you receive.

During your hospital stay, the doctors and nurses will monitor you closely. You'll also have a special brain scan (a CT scan) around one to two days after your procedure to check on your brain recovery. About three months (90 days) after your stroke, you'll have an assessment to see how well you've recovered your daily activities and your overall quality of life. This usually involves answering some questions about your health and how you're feeling. The total duration of active follow-up for the study is about three months.

Potential risks and benefits

Taking part in a study like this can have potential benefits, as it might lead to a better recovery for some people. However, there are also potential risks associated with any medicine; for example, Actilyse can increase the risk of bleeding. The study team will explain all known risks to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

—
Unverified
Spain

Common questions

What is a stroke?

A stroke happens when blood flow to part of the brain is stopped, often by a blood clot. This can damage brain cells and affect how the body works.

What is Actilyse?

Actilyse is a medicine used to dissolve blood clots. It's often called a 'clot-buster' and is already used in medicine for certain types of stroke.

What does 'mechanical thrombectomy' mean?

This is an emergency procedure used to physically remove a large blood clot from an artery in the brain, restoring blood flow.

Will I know if I'm getting the study medicine or a dummy medicine?

No, you won't know. This is a common practice in studies to make sure the results are fair and unbiased. Your doctors also won't know.

How long will I be involved in the study?

Your involvement in the study will mainly be focused on your hospital stay and then a follow-up assessment about three months after your stroke.