AuthorisedTherapeutic confirmatory (Phase III)Interventional

Intra-arterial t-PA infusion during mechanical thrombectomy in acute ischemic stroke: a randomized trial.

This research trial is focusing on people who have had a severe type of stroke (called an acute ischemic stroke) where a large blood vessel in the front part of the brain is blocked. Doctors are already using a procedure called mechanical thrombectomy to remove these clots. This study aims to see if giving a clot-busting medicine, called Actilyse, directly into the brain's artery during this procedure makes it even more effective. The main goal is to find out if this combined approach helps more people recover well and have little to no disability after their stroke, compared to just the mechanical thrombectomy alone. It will also look at whether this new way of giving the medicine is safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Vall D'hebron Institut De Recerca

Enrolment target

120

Start

13 May 2024

People with acute ischemic stroke (AIS) due to large vessel occlusion of the anterior circulation.

What is this study about?

Imagine your brain is like a city, and blood vessels are the roads that deliver all the essential supplies. When a road gets blocked by a clot, parts of the city don't get what they need, causing a stroke. This study is for people who have had a serious type of stroke where a big 'road' (a large blood vessel) in the front of their brain is completely blocked. This kind of stroke needs quick action to clear the blockage and restore blood flow.

Currently, doctors often use a procedure called mechanical thrombectomy. This is like a tiny rescue mission where a special tool is guided into the blocked blood vessel to grab and remove the clot. This trial is investigating whether adding a special clot-busting medicine, called Actilyse, directly into the artery during this procedure can make an even bigger difference.

The main aim is to see if this combined treatment helps more people recover really well from their stroke, meaning they have very little or no lasting problems, like being able to live independently and carry out daily activities. The study will also carefully check for any potential side effects or complications to make sure the treatment is safe.

Key takeaways

Targets severe stroke from large brain artery blockages.
Investigates adding clot-buster (Actilyse) during clot removal procedure.
Aims for better stroke recovery and reduced disability.
Carefully checks for safety and potential side effects.
Participation includes close monitoring and follow-up.

Who may be eligible?

This study is looking for adults who have recently had a specific type of stroke. To be considered, you must be 18 years old or older. There is no upper age limit for joining.

Crucially, your stroke needs to be caused by a large blood clot blocking a major artery in the front part of your brain. Doctors will need to confirm this with scans very soon after your stroke symptoms start.

Both men and women can take part in this research. Your medical team will carry out several checks to make sure this study is the right fit for you and that taking part would be safe.

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?
Was your stroke caused by a large clot blocking an artery in the front of your brain?
Are you able to provide consent (or can a family member provide consent for you if you're unable)?
Are you being treated at a hospital involved in this study?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would be receiving the standard treatment for your stroke, which is mechanical thrombectomy. In this study, some participants would also receive the clot-busting medicine (Actilyse) directly into the affected artery during the procedure, while others would not, allowing researchers to compare the two approaches. The decision on which group you are in is made by chance, like flipping a coin.

After your stroke treatment, doctors will closely monitor your recovery in the hospital. You will have follow-up assessments, including brain scans (CT scans), usually around 24 to 48 hours later, to check for any bleeding. Your progress will be tracked over time to see how well you are recovering and your ability to carry out daily tasks. The exact number of visits or the total length of follow-up isn't detailed here but will be explained fully by the study team.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the combined treatment proves to be more effective at improving recovery after a stroke. However, as with any medical procedure or medication, there are potential risks, including the possibility of bleeding in the brain or other complications related to the procedure or the medicine. All participants will be very closely monitored for these risks. Remember, deciding whether or not to join a study is entirely your choice, and you are free to withdraw at any time without 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
Spain

Common questions

What kind of stroke is this study for?

This study is for a specific type of severe stroke caused by a large blood clot blocking an artery in the front of your brain.

What is Actilyse?

Actilyse is a medicine often called a 'clot-buster' that helps dissolve blood clots.

What is mechanical thrombectomy?

It's a procedure where doctors use a special tool to physically remove a blood clot from an artery in the brain.

Will I definitely get the extra medicine?

No, whether you receive the extra medicine or not is decided by chance, like drawing numbers from a hat.

What is the main thing the study wants to find out?

The study wants to see if adding the clot-busting medicine during the procedure helps more people recover well and have less disability after their stroke.