Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of the efficacy of intra venous dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke with thrombolysis and eligible for thrombectomy: a single-center phase II trial.

This study is investigating a new way to help people who have had a stroke caused by a blood clot in the brain. They are testing a medicine called Pulmozyme, given directly into a vein. Patients in this study would have already received clot-busting medicine and are also having an operation to physically remove the clot, called a thrombectomy. The main goal is to see if Pulmozyme helps to completely open up the blocked blood vessel in the brain, allowing blood to flow normally again after the operation. Researchers will carefully check brain scans to measure how well the blood flow is restored. This is a Phase II study, meaning it's an early-stage trial trying to find out if the treatment is safe and shows promise.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondation A De Rothschild

Enrolment target

Start

26 Jul 2024

Ischemic stroke

What is this study about?

Imagine a pipe carrying water, and suddenly it gets blocked, stopping the flow. In your body, if a blood vessel in your brain gets blocked by a clot, it's called an ischemic stroke. This means a part of your brain isn't getting the blood and oxygen it needs, which can cause serious problems.

Doctors often try to clear these blockages. Sometimes they use 'clot-busting' medicines, and sometimes they also perform an operation called a 'thrombectomy' to physically remove the clot. This study is looking at an extra step: giving a medicine called Pulmozyme (which you'd receive through a drip into your vein) to see if it can help the blood vessel open up more completely and quickly after the clot has been removed.

The main aim is to see if, after the operation to remove the clot, your brain scans show that blood flow to the affected area is fully restored. Researchers will take special X-ray pictures of your brain's blood vessels (called angiography) to check this. They also want to see if Pulmozyme might reduce the size of brain damage or improve recovery.

Key takeaways

This study is for adults who have had a stroke caused by a blood clot.
It tests if a drug called Pulmozyme helps open blocked brain blood vessels after clot removal surgery.
Pulmozyme would be given through a drip into your vein.
The main goal is to see if blood flow to the brain is fully restored.
Participation involves extra brain scans and checks by doctors.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older, regardless of whether you are male or female. The study is specifically for people who have just experienced an ischemic stroke, meaning a stroke caused by a blood clot blocking an artery in the brain.

You would also need to be a candidate for two specific treatments for this type of stroke: first, you would have received a treatment called 'thrombolysis' (clot-busting medication), and second, you would also be suitable for a procedure called 'thrombectomy', which is an operation to physically remove the blood clot from your brain.

There might be other medical conditions or circumstances that would mean this study isn't right for you, and the study doctors will check all of these carefully to make sure it's safe for you 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 an ischemic stroke (stroke caused by a blood clot)?
Have you been treated with 'clot-busting' medicine (thrombolysis)?
Are you also suitable for an operation to remove the clot (thrombectomy)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive the study drug, Pulmozyme, through a drip into a vein, alongside your standard stroke treatments. After the main procedure to remove the clot (thrombectomy), doctors will take special X-ray pictures of your brain's blood vessels (angiography) to see how well the blood flow has been restored. Depending on the results of that first picture, they might take another one an hour later.

Over the next few days, you'll have more tests, including brain scans (MRI and CT scans) and physical examinations by the doctors. These will help them understand if the study drug has made a difference to the size of any brain damage, how well you are recovering, and to check for any side effects. The exact number of visits and tests will depend on your individual situation and how long you stay in hospital after your stroke. The full duration of your involvement will be explained by the study team.

Potential risks and benefits

Taking part in a study like this means you might be among the first to benefit from a new treatment approach for stroke, if Pulmozyme proves to be effective. However, there's no guarantee that the drug will help everyone, and because it's a new use for this medicine, there's always the possibility of unexpected side effects, although the study team will carefully monitor you. You might also experience side effects common to other stroke treatments or procedures. 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
France

Common questions

What is an ischemic stroke?

It’s a type of stroke that happens when a blood clot blocks a blood vessel going to your brain, stopping blood and oxygen from getting through.

What is Pulmozyme?

Pulmozyme is a medicine. In this study, doctors are investigating if giving it into a vein can help clear blood vessels in the brain after a stroke.

What is a thrombectomy?

It's an operation where doctors go into your blood vessel to physically remove a blood clot from your brain.

What is a Phase II trial?

This is an early stage of testing a new treatment. It helps doctors find out if the treatment is safe and if it shows promise for helping patients.

Will I get extra medical care if I join this study?

You will receive careful monitoring and follow-up as part of the study, in addition to your standard stroke care, to check on your progress and safety.