RecruitingPHASE4INTERVENTIONAL

Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake

The DO-IT study is investigating a treatment called intravenous thrombolysis (IVT) for people who have had a type of stroke called an ischemic stroke. This particular study focuses on patients who have recently taken specific blood-thinning medications called direct oral anticoagulants (DOACs). Currently, doctors are unsure if IVT is safe and effective in this group of patients. Researchers will randomly assign participants to receive either IVT alongside standard care, or just standard care. They want to find out if IVT leads to a better recovery 90 days after a stroke. This is an international study involving many stroke centers, and about 900 adults will take part.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

906

Start

14 Mar 2025

Estimated completion

30 Apr 2029

Ischemic Stroke

What is this study about?

Imagine you've just had a stroke caused by a blood clot blocking blood flow to your brain – this is called an ischemic stroke. A common treatment for this type of stroke is called 'intravenous thrombolysis' (IVT), sometimes known as a 'clot-busting drug'. This medicine is given directly into a vein and aims to dissolve the clot, restoring blood flow to the brain.

However, some people who have a stroke also take medicines called 'direct oral anticoagulants' (DOACs), which are blood thinners, for other health conditions. Doctors are usually very careful about giving clot-busting drugs to someone who has recently taken a blood thinner, because it could increase the risk of bleeding. This study aims to understand if giving IVT to stroke patients who have recently taken a DOAC is safe and helps them get better.

By comparing patients who receive IVT plus standard care with those who only receive standard care, the study hopes to find clearer answers. This is very important because if IVT is found to be safe and effective in these patients, it could mean more people get a treatment that helps reduce the long-term effects of a stroke. The results could change how doctors treat stroke patients in the future, particularly those who are already on blood thinners.

Key takeaways

This study evaluates clot-busting medicine for stroke patients on blood thinners.
It aims to see if the treatment is safe and effective in this specific group.
Participation involves being randomly assigned to treatment or standard care.
The main goal is to measure recovery 90 days after the stroke.
The findings could change future stroke treatment guidelines.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to have recently had a stroke caused by a blood clot (an ischemic stroke) and be suitable for the clot-busting treatment, in your doctor's opinion. You also need to have taken a direct oral anticoagulant (DOAC) – a type of blood thinner – within the last 48 hours, or have a prescription for one but aren't sure exactly when you last took it.

Timing is really important for stroke treatment. You would generally need to be able to start the study treatment within about 4.5 hours of when your stroke symptoms started or when you were last known to be well. In some cases, if specific brain scans show certain patterns, you might still be able to join if treatment can start within 4.5 hours of when your symptoms were noticed.

There are also reasons why you might not be able to join. For example, if you have other health conditions that make clot-busting treatment unsafe, or if you are pregnant or breastfeeding. If doctors plan to remove the clot using a procedure rather than just medication, you might also be excluded, though a small number of these patients may be included.

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 a stroke caused by a blood clot?
Have I taken a blood thinner (DOAC) in the last 48 hours?
Am I able to start treatment within about 4.5 hours of my stroke symptoms starting?
Am I over 18 years old?
Am I NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. You might receive the clot-busting drug (intravenous thrombolysis) plus the usual care for stroke, or you might receive only the usual care. You won't know which group you are in, and neither will the doctors treating you immediately, to ensure fair comparison.

Throughout the study, doctors and nurses will monitor your health closely. This will involve regular check-ups, repeated brain scans, and assessments to see how you are recovering from the stroke. The main goal is to see how well you are doing 90 days (about three months) after your stroke. This assessment will help determine if the treatment made a difference. The total duration of your active participation, including follow-up, will be around three months from the time of your stroke.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study could be that if you receive the clot-busting drug, it might help improve your recovery from the stroke, especially since doctors are currently uncertain about its use with your specific blood thinner. However, there's also a known risk with clot-busting drugs, which is an increased chance of bleeding, including bleeding in the brain. The study aims to look at these risks carefully in your specific situation. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (14)

UZ Leuven
Verified postcode
Leuven, Belgium· Not yet recruiting
Hamilton Health Sciences
Verified postcode
Hamilton, Canada· Not yet recruiting
GHU Paris Psychiatrie et Neurosciences, Sainte Anne
Verified postcode
Paris, France· Not yet recruiting
Heidelberg University Hospital
Verified postcode
Heidelberg, Germany· Not yet recruiting
"Attikon" University Hospital
Verified postcode
Athens, Greece· Not yet recruiting
National Cerebral and Cardiovascular Center Osaka
Verified postcode
Osaka, Japan· Not yet recruiting
Academic Medical Center Amsterdam, Department of Neurology
Verified postcode
Amsterdam, Netherlands· Not yet recruiting
Canterbury District Health Board
Verified postcode
Christchurch, New Zealand· Not yet recruiting
Akershus Hospital
Verified postcode
Oslo, Norway· Not yet recruiting
Lisbon Central University Hospital Centre
Verified postcode
Lisbon, Portugal· Not yet recruiting
Vall d'Hebron Stroke Center
Verified postcode
Barcelona, Spain· Not yet recruiting
University Hospital Basel
Verified postcode
Basel, Switzerland· Not yet recruiting

Common questions

What is an ischemic stroke?

An ischemic stroke is caused by a blood clot blocking an artery that supplies blood to the brain.

What are DOACs?

DOACs are direct oral anticoagulants, which are a type of medicine commonly known as blood thinners.

What does 'randomised' mean?

Being 'randomised' means you are put into a treatment group by chance, like drawing lots, to ensure a fair comparison.

Why can't pregnant women join?

Pregnant or breastfeeding women are usually excluded from drug trials to protect the baby and because the effects during pregnancy are unknown.

Will I know my treatment group?

No, you won't know which treatment you are receiving, nor will the doctors who assess your recovery. This is to keep the study fair.

How to find out more

Thomas Meinel, MD, PhD

thomas.meinel@insel.ch +41 31 66 4 25 67 Official trial record

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