AuthorisedTherapeutic confirmatory (Phase III)Interventional

“Intravenous Thrombolysis With Tenecteplase Plus Thrombectomy Versus Thrombectomy Alone In Patients With A Large Ischemic Stroke: A Multicentre Randomized Controlled Trial” THE IVT ALL IN TRIAL

This study, called IVT ALL IN, is researching a treatment for adults who have had a severe stroke due to a large blood clot in the brain. Researchers want to find out if giving a clot-busting medicine called Tenecteplase (also known as Metalyse) just before surgically removing the clot helps patients recover better than only removing the clot. They are particularly interested in how well people can move around and live independently three months after their stroke. Scientists will also look at whether the blood clot is successfully cleared and if there are any side effects. This is a "Phase III" study, meaning it's a key step to see if this new approach should become a standard treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

486

Start

12 Mar 2026

Adult patients with a LVOS with large core within 9 hours of symptoms onset or last seen well or with a diffusion weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch in case of unknown onset.

What is this study about?

Imagine you've had a stroke caused by a big blood clot blocking an important blood vessel in your brain. This study, called IVT ALL IN, is looking for the best way to help people in this situation. Currently, a common treatment is to physically remove the clot using a special procedure. This study wants to see if giving a medicine called Tenecteplase (you might hear it called Metalyse) just *before* removing the clot could lead to even better recovery.

Think of Tenecteplase as a powerful 'clot-buster' medicine. The researchers want to know if breaking up some of the clot beforehand makes the clot removal procedure more successful, or helps improve the blood flow to the brain more quickly, leading to a better recovery for patients. They are especially interested in how well people can move around and live independently about three months after their stroke.

This is a "Phase III" study, which means it's a large and important step in testing this treatment. If the study shows that giving Tenecteplase beforehand is more effective and safe, it could change how doctors treat this type of stroke in the future, helping more people recover better.

Key takeaways

This study is for adults with a serious stroke caused by a large blood clot.
It compares two treatments: clot-busting medicine PLUS clot removal, versus clot removal alone.
The main goal is to see if the combined treatment helps people recover better and become more independent.
Participation involves either one of the treatments and follow-up check-ups for a year.
The study aims to improve future stroke care.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently had a severe stroke. Specifically, it's for those with a large blood clot causing the stroke, and whose stroke was identified within nine hours of when symptoms started, or nine hours from when they were last seen well. If the exact time of the stroke isn't known, patients might still be eligible if specific brain scans show a particular pattern.

Both men and women can take part in this study. The medical team will check detailed brain scans and other health information to make sure someone fits all the criteria for the study. It's really important that participants meet certain health requirements to ensure their safety and the reliability of the study results.

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 an adult (18 years or older)?
Have you recently had a stroke caused by a large blood clot?
Were your stroke symptoms noticed within nine hours, or were you last seen well within nine hours?
Are you able to attend follow-up appointments for up to a year?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would either receive the clot-busting medicine called Tenecteplase shortly after your stroke, followed by the standard procedure to remove the blood clot, or you would just have the standard clot-removal procedure. You wouldn't get to choose which treatment you receive; it's decided randomly, like flipping a coin.

After your initial treatment, you'll have regular check-ups with the study team. This will involve visits to the hospital and possibly phone calls. These check-ups will help doctors understand how you're recovering. They will ask questions about your daily activities and might do some simple tests. The main check-up for the study's purpose will be three months after your stroke, where doctors will assess your ability to move around independently. There will also be a follow-up after one year to see how you are doing in the longer term. The total duration of your participation in the study, including all follow-ups, would be about one year.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that the combination treatment might lead to a better recovery from your stroke compared to the usual treatment, helping you regain more independence. However, there's always a risk that new treatments might not work as expected, or could cause side effects. For example, clot-busting medicines can increase the risk of bleeding. The study team will carefully monitor you for any side effects throughout your participation. You have the right 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.

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Unverified
France

Common questions

What is Tenecteplase?

Tenecteplase (also known as Metalyse) is a medicine designed to break down blood clots, which can improve blood flow to the brain after a stroke.

What does 'thrombectomy' mean?

Thrombectomy is a procedure where doctors physically remove a blood clot from an artery in the brain to restore blood flow.

What does 'independent ambulation' mean?

This basically means being able to move around and walk independently, without needing help from others.

Will I know which treatment I'm getting?

No, you won't know initially. The treatment you receive (Tenecteplase plus thrombectomy, or thrombectomy alone) is decided randomly, to ensure the study results are fair and unbiased.

How long will I be followed in this study?

You will be followed up for a total of one year after your stroke to see how you are recovering.