AuthorisedTherapeutic use (Phase IV)Interventional

EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation

This study is for people who have a heart condition called atrial fibrillation and have previously experienced a brain bleed. We are looking at a medicine called Lixiana (edoxaban), which helps prevent blood clots. The main aim is to see if Lixiana can reduce the risk of different types of stroke or other serious blood clot problems throughout the body. At the same time, we need to make sure the medicine is safe and doesn't cause serious bleeding. We are comparing two different doses of Lixiana to understand how it works best for these patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International

Enrolment target

380

Start

09 Dec 2024

High risk atrial fibrillation patients with previous intracranial hemorrhage

What is this study about?

This study is called 'EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation,' but let's break that down. Essentially, it's looking at a medicine called Lixiana (you might know its generic name, edoxaban). This medicine is a type of 'blood thinner' that helps to prevent blood clots. It's being studied in people who have two important health conditions.

Firstly, these people have a heart problem called atrial fibrillation. This condition makes your heart beat irregularly and can increase your risk of forming blood clots, which can then travel to the brain and cause a stroke. Secondly, everyone in this study has also had a brain bleed (medical term: intracranial hemorrhage) in the past. This is a very serious event, and doctors need to be careful when prescribing blood thinners to people who have had one, as these medicines can sometimes increase the risk of bleeding.

So, the main goal of this study is to find out if Lixiana can help prevent future strokes in these patients, including different types of stroke and other clot-related issues. At the same time, it's really important to make sure that Lixiana doesn't cause more serious bleeding, especially in the brain. Researchers will be carefully checking how well the medicine works and how safe it is, using two different doses of Lixiana, 30mg and 60mg.

Key takeaways

The study investigates Lixiana (edoxaban) for people with atrial fibrillation and a past brain bleed.
The main goals are to prevent strokes and ensure the medicine is safe from serious bleeding.
Two doses of Lixiana (30mg and 60mg) are being compared.
Participants will be closely monitored with regular check-ups and tests.
It aims to help doctors better manage patients with this complex set of conditions.

Who may be eligible?

To be able to join this study, participants must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

The most important health requirements are that you must have a specific heart rhythm problem called atrial fibrillation. You also need to have had a brain bleed in the past. Your doctor will carefully check your medical records to make sure you meet all the health criteria for the study.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with atrial fibrillation?
Have you experienced a brain bleed in the past?
Are you able to take daily medication (Lixiana) as prescribed?
Are you willing to attend regular hospital or clinic visits for check-ups?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be taking either a 30mg or 60mg tablet of Lixiana each day, as directed by the study doctors. You would have regular appointments, which might include check-ups, blood tests, and scans, to see how you are doing and how the medicine is affecting you. These visits would allow the research team to monitor your health closely, check for any side effects, and track your progress. The study will involve ongoing follow-up for a period of time to fully assess the medicine's effects.

Potential risks and benefits

Potential benefits of joining could include receiving a treatment that might reduce your risk of stroke, and helping doctors learn more about managing your condition, which could help many others in the future. However, as with any medicine, there are potential risks, especially with blood thinners, which can increase the chance of bleeding. The study team will carefully monitor you for any side effects, particularly serious bleeding. Remember, participating in a study is always your choice, and you have the right to withdraw at any time without giving a reason.

Locations (10)

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Spain
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Austria
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Czechia
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Greece
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Belgium
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Italy
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Germany
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Denmark
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Slovakia
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Portugal

Common questions

What is atrial fibrillation?

It's a heart condition where your heart beats irregularly, which can increase your risk of blood clots and strokes.

What is a brain bleed?

A brain bleed, or intracranial hemorrhage, is when there's bleeding inside your skull. It's a serious medical event.

What is Lixiana (edoxaban)?

It's a medicine often called a 'blood thinner' that helps prevent blood clots from forming in your body.

Why are two doses being studied?

Researchers want to find out which dose (30mg or 60mg) is most effective at preventing strokes while being as safe as possible from bleeding.

Will I know which dose I'm taking?

The study design will determine this. Often, in studies like this, participants are given a specific dose without knowing if it's the higher or lower dose, to ensure fair results.