Not yet recruitingOBSERVATIONAL

Tenecteplase Treatment in Ischemic Stroke Registry

This study, called TETRIS, is collecting information about how a medicine called Tenecteplase is used to treat people who have had a stroke caused by a blood clot (called an ischemic stroke). For many years, a drug called Alteplase has been used to dissolve these clots. However, Tenecteplase is a newer drug that's easier to give and has shown promising results in earlier trials, sometimes working better than Alteplase, especially for larger clots. This study aims to gather real-world information about how Tenecteplase is being used across different hospitals and how patients are doing after receiving it. This will help doctors understand its benefits and how to best use it in stroke care.

At a glance

Status

Not yet recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

5,000

Start

01 Sep 2022

Estimated completion

01 Mar 2028

Stroke, Acute

What is this study about?

This study, called the Tenecteplase Treatment in Ischemic Stroke (TETRIS) Registry, is about understanding how a newer medicine called Tenecteplase is being used to treat a type of stroke caused by a blood clot, known as an ischemic stroke. For a long time, the main treatment for these strokes has been a medicine called Alteplase, which helps dissolve the clot and restore blood flow to the brain. Alteplase needs to be given carefully over an hour.

Now, there's Tenecteplase. It's similar to Alteplase but has a few key differences that could make it better for some patients. Tenecteplase can be given as a single, quick injection, which is much simpler than Alteplase. Research has already suggested that Tenecteplase might be more effective at dissolving larger blood clots and could lead to better recovery for patients. Some guidelines already recommend Tenecteplase in certain situations.

However, doctors want to gather more information about how Tenecteplase works in everyday medical practice across many hospitals, not just in controlled research studies. This study is collecting data from patients who are already receiving Tenecteplase as part of their standard stroke treatment. By looking at a wide range of patients, doctors hope to get a clearer picture of how well Tenecteplase works for different people and to help improve future stroke care.

Key takeaways

The study looks at how a stroke medicine called Tenecteplase works in real hospitals.
It helps doctors understand the treatment's benefits and how to use it best.
You won't have any extra tests or different treatments; information is collected from your usual care.
Your participation helps improve stroke care for others in the future.
This study focuses on strokes caused by blood clots.

Who may be eligible?

To be included in this study, you would need to be at least 18 years old and have had a confirmed stroke caused by a blood clot in the brain. Crucially, your doctors would have decided that Tenecteplase is the right treatment for you and would have given it to you within a specific timeframe after your stroke symptoms started, or if scans showed you could still benefit from it.

You would not be included if you couldn't receive clot-dissolving treatment for any reason, or if you received the older medicine, Alteplase, instead of Tenecteplase. This study is specifically looking at Tenecteplase. Also, if your stroke was caused by a problem with veins rather than arteries, you wouldn't be part of this particular study.

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?
Did your doctors decide to treat your stroke with Tenecteplase?
Did you receive the treatment within the time window suggested by your doctors for your type of stroke?

Answer every question to see your result.

What does participation involve?

This study is an 'observational' study, which means you wouldn't be asked to do anything extra. Your doctors would already be treating you for your stroke with Tenecteplase as part of your standard medical care. The study involves collecting information that doctors and nurses routinely gather during your treatment and recovery, such as details about your stroke, the treatment you received, and how you are recovering. There are no additional appointments, tests, or medications specifically for this study. The researchers will simply look at the information already in your medical records.

Potential risks and benefits

Since this is an observational study, you wouldn't be undergoing any additional procedures or treatments beyond your usual medical care for stroke. Therefore, there are no extra risks associated with participating in this study compared to not participating. The potential benefit is that by allowing your medical information (kept anonymous) to be used, you would be helping doctors better understand how Tenecteplase works in real-world settings. This can lead to improved stroke treatments for future patients. You have the right to withdraw your consent for your data to be used at any time, without affecting your medical care.

Locations (1)

Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine
Verified postcode
Paris, France

Common questions

What is an ischemic stroke?

An ischemic stroke happens when a blood clot blocks blood flow to part of the brain.

What is Tenecteplase?

It's a medicine given through a drip that helps dissolve blood clots that cause strokes.

Is Tenecteplase a new treatment?

While not brand new, it's a newer medication for stroke that is being increasingly used and studied.

Will I get extra tests or medicines if I join?

No, this study only collects information from your routine care; you won't have any extra treatments or tests.

How does my information stay private?

Your personal details will be kept confidential, and your data will be anonymised so you can't be identified.

How to find out more

Sonia Alamowitch, MD

sonia.alamowitch@aphp.fr 1 71 97 06 51 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.