RecruitingOBSERVATIONAL

Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants

This study, called DO-IT, is looking at how safe and effective clot-busting medicines are for people experiencing a stroke. Specifically, it focuses on patients who have recently taken a type of blood thinner called a Direct Oral Anticoagulant (DOAC). Researchers want to see if these clot-busting treatments improve recovery for these patients. They are collecting information from about 2800 adults admitted for a stroke in hospitals worldwide. They'll compare those who took DOACs and received the clot-buster, those who took DOACs but didn’t get the clot-buster, and those who didn’t take DOACs but did get the clot-buster. Patients will be followed for 90 days to track their progress. The study hopes to show that giving clot-busters to stroke patients who recently took DOACs is not too risky and can lead to better outcomes.

At a glance

Status

Recruiting

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

2,800

Start

01 Jan 2024

Estimated completion

31 Dec 2026

Ischemic Stroke

What is this study about?

This research, called the DO-IT study, is an important project looking into treatments for a type of stroke called an ischemic stroke. This happens when a blood clot blocks blood flow to the brain. The study focuses on a specific group of stroke patients: those who have recently taken certain blood-thinning medications, known as Direct Oral Anticoagulants (DOACs).

Doctors sometimes use powerful clot-busting medicines, like Alteplase or Tenecteplase, to treat ischemic strokes. However, there are concerns about giving these medicines to people who are already taking blood thinners, as it could increase the risk of bleeding. This study aims to find out if it's safe and helpful to give these clot-busting treatments to stroke patients who have recently taken DOACs.

Researchers will gather information from many stroke patients in hospitals around the world. They will compare people who received a clot-buster after taking DOACs with those who took DOACs but didn't get the clot-buster, and also with patients who didn't take DOACs but did get the clot-buster. By carefully observing these different groups, the study hopes to determine if giving clot-busting treatment to patients who have recently taken DOACs leads to better recovery without causing serious bleeding problems.

Key takeaways

This study helps understand stroke treatment for patients on blood thinners.
It focuses on clot-busting drugs (Alteplase, Tenecteplase) and certain blood thinners (DOACs).
Researchers will observe how patients recover over 90 days.
The goal is to see if these treatments are safe and effective together.
Participation contributes to improving future stroke care.

Who may be eligible?

To be considered for this study, you would typically be an adult (18 years or older) who has recently experienced an acute ischemic stroke. Your stroke symptoms would need to have started within the last 12 hours, and your doctor would have decided that a clot-busting treatment (like Alteplase or Tenecteplase) is a suitable option for you based on standard guidelines. An important part of this study is that you would have either taken a Direct Oral Anticoagulant (DOAC) blood thinner within 48 hours before the expected clot-busting treatment, or you are currently prescribed DOACs and the exact time of your last dose is unknown but within the last 7 days.

There are also reasons why you might not be able to join. For example, if you have any bleeding in your brain, discovered on a CT or MRI scan, you wouldn’t be able to take part. Also, if you have other medical conditions that make clot-busting treatment unsafe, or if you had significant disability before your stroke (such as severe dementia), you would not be eligible. Pregnancy or breastfeeding, and known severe allergies to the medicines being studied, would also prevent participation.

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 an ischemic stroke (clot-related stroke)?
Has your stroke started within the last 12 hours?
Have you taken a DOAC blood thinner recently (within the last 48 hours or week)?
Do you have any bleeding in your brain?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the study will involve collecting information about your stroke, your medical history, and the treatments you receive in the hospital. This includes details about any clot-busting medication you might be given. Researchers will also collect information about your health and recovery over a period of 90 days after your stroke. This follow-up might involve doctors or nurses checking in with you to see how you are doing and your overall recovery. You won't be asked to take any new or experimental medications as part of this study; rather, researchers are observing how existing approved treatments are used in real-world situations.

Potential risks and benefits

The main benefit of participating in this study is that you would be contributing valuable information to medical science, which could help improve stroke care for future patients. This study doesn't involve new medications, but rather observes standard treatments. Like any medical treatment, clot-busting medications carry risks, such as bleeding complications, especially in the brain. The study aims to better understand these risks in patients also taking blood thinners. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (33)

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

Medical University of Innsbruck
Verified postcode
Innsbruck, Austria· Not yet recruiting
Cliniques Universitaires Saint Luc
Verified postcode
Brussels, Belgium· Not yet recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Not yet recruiting
The University of British Columbia | Vancouver General Hospital
Verified postcode
Vancouver, Canada· Not yet recruiting
CHU Caen
Verified postcode
Caen, France· Not yet recruiting
Nordwest-Krankenhaus Sanderbusch
Unverified
Sanderbusch, Germany· Not yet recruiting
Universitäsklinikum Tübingen
Verified postcode
Tübingen, Germany· Not yet recruiting
Dept. of Medicine, University of Thessaly
Verified postcode
Larissa, Greece· Recruiting
A.O.R.N. Antonio Cardarelli Hospital
Verified postcode
Naples, Italy· Not yet recruiting
Ospedali Riuniti Hospital
Verified postcode
Palermo, Italy· Not yet recruiting
Ospedale "Bufalini", Cesena
Verified postcode
Perugia, Italy· Recruiting
AUSL-IRCCS di Reggio Emilia
Verified postcode
Reggio Emilia, Italy· Not yet recruiting

Common questions

What is an ischemic stroke?

An ischemic stroke happens when a blood clot blocks blood flow to part of your brain, damaging brain cells.

What are DOACs?

DOACs are medications that thin your blood, prescribed to prevent blood clots. They stand for Direct Oral Anticoagulants.

What are Alteplase and Tenecteplase?

These are clot-busting medicines given by drip to dissolve blood clots that cause an ischemic stroke.

Will I be given a new medicine?

No, this study observes how approved medicines (like clot-busters) are used in real stroke patients, not new experimental ones.

How long will I be followed in the study?

If you take part, your medical information will be followed for 90 days (about 3 months) after your stroke.

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.