Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Safety and Efficacy of intra-arterial Tenecteplase for non-complete reperfusion of intracranial occlusion

This research study is investigating a treatment called Metalyse for people who have had a type of stroke called an ischaemic stroke. This happens when a blood clot blocks blood flow to the brain. Sometimes, after initial treatments, the blocked blood vessel isn't fully opened. This study aims to see if Metalyse, given directly into the affected artery, can help to fully unblock these vessels, allowing blood to flow more freely. We're looking at how well it works and if it's safe. Ultimately, we hope to improve recovery and reduce long-term disability for stroke patients by improving blood flow to the brain.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Insel Gruppe AG

Enrolment target

140

Start

12 Jul 2023

Acute ischemic strokes with incomplete reperfusion

What is this study about?

This study is about a type of stroke called an ischaemic stroke. This happens when a blood clot blocks an artery, stopping blood from reaching part of the brain. When this happens, doctors sometimes try to remove the clot or break it up to restore blood flow. However, sometimes these initial treatments don't completely clear the blockage, meaning blood isn't flowing as well as it should.

This research is looking at a medicine called Tenecteplase, also known as Metalyse. It's already used for other conditions, but this study is to see if giving it directly into the blocked artery can help more people after a stroke where the blockage wasn't fully cleared. The main aim is to see if Metalyse can help to fully open these blood vessels and improve blood flow to the brain.

We also want to understand if better blood flow leads to better recovery for patients. We'll be looking at things like how much disability patients have, their overall health, and their quality of life in the weeks and months after their stroke. This is a "Phase III" study, which means it's a large, important study designed to confirm if this treatment is effective and safe, and potentially help it become a standard treatment in the future.

Key takeaways

The study explores Metalyse for incompletely blocked stroke arteries.
It aims to improve blood flow and stroke recovery.
It's for adults (18+) who have had an ischaemic stroke.
Participation involves receiving the medicine and follow-up checks for about three months.
The study assesses effects on disability, quality of life, and safety.

Who may be eligible?

This study is looking for adults who have recently had a specific type of stroke caused by a blood clot. You would need to be at least 18 years old; there's no upper age limit.

Critically, this study is for people whose blood vessel blockage wasn't fully cleared by the initial treatments they received. This means some of your brain wasn't getting enough blood, even after doctors tried to help.

Both men and women are welcome to take part. Your medical team will carefully check your health and your stroke details to see if you're a suitable candidate for this study. They'll make sure it's the right fit for you.

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.

Have I recently had an ischaemic stroke (a stroke caused by a clot)?
Was my blood vessel not completely opened by initial treatments?
Am I at least 18 years old?
Am I currently in the UK?
Has my doctor suggested I might be suitable for a stroke study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, doctors will give you a medicine called Metalyse through a thin tube placed in an artery, usually in your leg, which goes up to the affected area in your brain. This is similar to how some initial clot-busting treatments are given. You would then be closely monitored by the medical team.

Over the next few days and weeks, you would have regular check-ups. These would include assessments of your recovery, such as how you're moving and thinking, and your general well-being. Some of these checks would happen within the first 24 hours, and others at about three months after your stroke. These follow-up appointments allow us to see how you're progressing and how the treatment might have affected your recovery. The total duration of your participation would be about three months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that Metalyse might help to clear your blood vessel more completely, potentially leading to a better recovery from your stroke. However, there's also a risk, as giving medicine into an artery can have side effects, such as bleeding, which your doctor will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Finland
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Unverified
Austria
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Unverified
Belgium
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Unverified
Germany
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Unverified
Portugal
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Unverified
Netherlands

Common questions

What is an ischaemic stroke?

An ischaemic stroke happens when a blood clot blocks a blood vessel that supplies blood to the brain, causing damage.

What is Metalyse?

Metalyse (Tenecteplase) is a medicine that helps to dissolve blood clots.

Why is this study happening?

This study wants to see if Metalyse can help people whose blood vessels aren't fully opened after initial stroke treatments, aiming for better recovery.

Will I get the study drug if I join?

If you are eligible and agree to take part, you would receive the study drug, Metalyse, and be carefully monitored.

How long will I be in the study?

Your participation in the study, including follow-up appointments, would last for about three months after your stroke.