RecruitingPHASE3INTERVENTIONAL

Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic Stroke

This important study is investigating an additional treatment for people who have had a severe stroke caused by a major blockage in the blood vessels at the front of their brain. Doctors usually remove these clots, but not everyone fully recovers. This trial is testing if giving a clot-busting medicine (called Alteplase) directly into the artery right after the initial clot removal can help clear smaller blockages that the first treatment might miss. The aim is to see if this extra step improves a patient's recovery and ability to live independently three months after their stroke. Researchers also want to make sure the treatment is safe and cost-effective for the healthcare system.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Central Hospital, Nancy, France

Enrolment target

626

Start

01 Jun 2025

Estimated completion

01 Jul 2029

Stroke, Acute Ischemic

What is this study about?

Stroke happens when the blood supply to part of your brain is cut off, often because of a blood clot. This is called an ischemic stroke. It's a serious condition that can lead to disability or even death. While treatments have improved, about half of the people who have a severe stroke still don't fully recover their independence.

One common treatment for a severe stroke, especially when a large blood vessel in the front of the brain is blocked, is called mechanical thrombectomy. This is where doctors use special tools to physically remove the clot. This study is looking at a new approach to try and improve recovery even further. After the initial clot removal, sometimes there are still tiny clots or blockages that are too small for the tools to reach.

This trial wants to find out if giving a special medicine called Alteplase directly into the artery can help clear these remaining smaller blockages and boost the blood flow to the brain, leading to a better recovery for patients. This is an extra step to see if we can get even better results than current treatments alone. The main goal is to see if patients who receive this additional medicine are more independent three months after their stroke compared to those who don't.

Key takeaways

This study evaluates an extra treatment for severe strokes caused by large clots.
It aims to improve patient recovery and independence after stroke.
The treatment involves a clot-busting medicine given directly into the brain artery.
Researchers will monitor safety and how well patients recover over three months.
Your standard stroke care will not be affected regardless of participation.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have recently had a specific type of stroke caused by a large blood clot in a main artery at the front of your brain. Before your stroke, you should have been able to live independently with few or no difficulties.

There are also some important reasons why you might not be able to join. For example, if you have certain blood conditions, are taking medicines that thin your blood significantly, or if there were serious complications during your initial stroke treatment, you might not be eligible. Also, if you're a woman of childbearing age, you would need to be using effective contraception.

Doctors will carefully check all your medical information, including your scans and blood test results, to make sure this study is safe and suitable for you. They will also need to be sure you can attend follow-up appointments for three months after your stroke.

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 at least 18 years old?
Did you have a stroke caused by a large clot in the front of your brain?
Were you able to live independently before your stroke?
Do you have any conditions that prevent you from taking blood-thinning medicines?
Are you able to attend follow-up appointments for three months?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will give you a special clot-busting medicine called Alteplase directly into your artery for about 15 minutes, right after your initial stroke treatment (like clot removal). This will happen while you are still in the special room where they perform stroke procedures.

During your stay in the hospital, and for three months afterwards, the study team will carefully monitor your health and recovery. This will involve regular check-ups, potentially more scans, and assessments to see how you are doing. You'll have follow-up visits to check your progress and see how well you've recovered your daily abilities.

Potential risks and benefits

Participating in this study might offer the potential benefit of a better recovery from your stroke, as the extra medicine could help clear more blockages and improve blood flow to your brain. However, like all medical treatments, there are potential risks, including a higher chance of bleeding in the brain due to the strong clot-busting medicine. The research team will monitor you very closely for any side effects. Remember, joining any study is completely voluntary, and you are free to withdraw at any time without affecting your usual medical care.

Locations (1)

CHRU Nancy
Verified postcode
Nancy, France· Recruiting

Common questions

What kind of stroke is this study for?

This study is for people who have had a severe stroke caused by a blockage in a large blood vessel at the front of their brain.

What is Alteplase?

Alteplase is a medicine that helps dissolve blood clots. In this study, it's given directly into the artery.

Will I still get the standard stroke treatment?

Yes, you will receive standard stroke treatment, and this study is testing if adding this extra step *after* that treatment improves outcomes.

How long will I be involved in the study?

You'll be closely monitored during your hospital stay and then followed up for three months after your stroke.

What happens if I don't want to be in the study?

That's perfectly fine. Your decision will not affect the excellent care you receive for your stroke.

How to find out more

Benjamin GORY, MD, PHD

b.gory@chru-nancy.fr +33 3 83 85 15 01 Official trial record

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