Active not recruitingPHASE4INTERVENTIONAL

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

The ENRICH-AF study is investigating a medicine called edoxaban for people who have an irregular heartbeat (atrial fibrillation) and have previously experienced bleeding in the brain (intracranial hemorrhage). People with atrial fibrillation are at a higher risk of stroke, and blood thinners like edoxaban are often used to prevent this. However, after a brain bleed, using blood thinners can be complicated. This study wants to see if edoxaban can safely lower the risk of future strokes or blood clots without causing more bleeding. It's comparing edoxaban to standard care, which means not taking strong blood thinners. The goal is to find the best way to protect people from strokes after they've had a brain bleed.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Population Health Research Institute

Enrolment target

948

Start

20 Sep 2019

Estimated completion

13 May 2026

Intracranial Hemorrhages Atrial Fibrillation

What is this study about?

The ENRICH-AF study is looking into an important question for people who have two specific health conditions: an irregular heartbeat called atrial fibrillation, and a history of bleeding inside the brain (doctors call this an intracranial hemorrhage).

Normally, if you have atrial fibrillation, doctors often prescribe medicines to thin your blood. This is because atrial fibrillation increases your risk of having a stroke caused by a blood clot. These blood-thinning medicines prevent clots from forming. However, if you've already had a brain bleed, taking blood thinners can be risky, as they might increase the chance of another bleed. This creates a difficult situation for doctors and patients: how do you prevent a stroke without causing another serious bleed?

This study aims to find a safer path forward. It's testing a specific blood-thinning medicine called edoxaban. Researchers want to see if edoxaban can effectively prevent strokes and other blood clots in people who have atrial fibrillation and have had a past brain bleed, while also being safe enough not to cause further bleeding. They are comparing edoxaban to current standard care, which usually means avoiding strong blood thinners after a brain bleed. The results of this study could help many people and their doctors make better decisions about preventing strokes in these complex situations.

Key takeaways

The study tests edoxaban, a blood thinner, for stroke prevention.
It's for people with an irregular heartbeat (atrial fibrillation) and a history of brain bleeds.
The main goal is to see if edoxaban is safe and effective in this group.
Participants will be randomly assigned to edoxaban or standard care.
This research hopes to provide clear guidance for doctors and patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would generally need to be at least 45 years old and have received a diagnosis of an irregular heartbeat called atrial fibrillation. A key requirement is also having had a previous brain bleed (intracranial hemorrhage). This could be caused by various things, but certain types of brain bleeds are specifically included, such as those within the brain tissue or its fluid-filled spaces, or certain subdural hematomas (bleeding under the brain's outer covering).

There are also some reasons why you wouldn't be able to join. For example, if your brain bleed happened very recently (within the last 14 days), or if the bleed was caused by certain other medical conditions like a tumour or infection. You also wouldn't be able to join if you need to take other blood-thinning medicines for different reasons (like an artificial heart valve), or if you have severe kidney problems, low blood cell counts, uncontrolled high blood pressure, or other serious bleeding issues. Being pregnant or breastfeeding would also exclude you from participating.

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 45 years old or older?
Have you been diagnosed with atrial fibrillation?
Have you had a brain bleed (intracranial hemorrhage) before?
Do you have a personal risk score for stroke (CHA2DS2-VASc) of 2 or higher?
Have you had a brain bleed within the last 14 days? (If yes, you likely can't join.)
Do you have severe kidney problems or other serious bleeding issues? (If yes, you likely can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first need to sign a consent form, showing you understand what's involved. You would then be randomly assigned to one of two groups: one group would receive the medicine edoxaban, and the other would receive standard medical care, which might include antiplatelet medicine or no blood thinner at all. You wouldn't get to choose which group you're in, and your doctor also wouldn't know which treatment you are receiving (this helps keep the results fair).

You would take either edoxaban (usually 60mg or a lower 30mg dose depending on other factors) once a day, or continue with your assigned standard care. The study involves regular visits to the hospital or clinic for check-ups, probably every few months, where doctors will monitor your health, take blood samples, and ask you about any new symptoms or side effects. The study will follow all participants until a certain number of main study events (like strokes) have occurred. This is expected to be about 12 months after the last person joins the study, but the overall time you spend in the study could vary.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of closer monitoring of your health, and you might receive a new treatment that could reduce your risk of stroke. While edoxaban is a common medicine, for people with a history of brain bleeds, there's always a risk of potential side effects, including the possibility of another bleed, although the study is carefully designed to assess this. You might also experience side effects from the medication, such as bruising or minor bleeding. You are completely free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (152)

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

Alexian Brothers Medical Center
Verified postcode
Elk Grove Village, United States
Presence Care Transformation Corporation
Verified postcode
Lisle, United States
Tulane University Medical Center
Verified postcode
New Orleans, United States
New York Presbyterian - Queens
Verified postcode
Queens, United States
The Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States
Allegheny General Hospital
Verified postcode
Pittsburgh, United States
The University of Texas at Austin, Dell Medical School
Verified postcode
Austin, United States
Texas Tech University Health Sciences Center at El Paso
Verified postcode
El Paso, United States
Baylor St. Luke's Medical Center
Verified postcode
Houston, United States
MultiCare Institute for Research & Innovation
Verified postcode
Tacoma, United States
Stat Research S.A.
Verified postcode
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Verified postcode
Buenos Aires, Argentina

Common questions

What is atrial fibrillation?

Atrial fibrillation (AF) is a common type of irregular and often very fast heartbeat. It can increase your risk of stroke.

What is an intracranial hemorrhage?

This is the medical term for bleeding inside the skull, commonly referred to as a 'brain bleed.' It can be serious.

What is edoxaban?

Edoxaban is a type of medicine that thins the blood. It's often used to prevent strokes and blood clots in people with atrial fibrillation.

Will I know which treatment I'm receiving?

No, this is a 'blinded' study for participants and doctors. This helps ensure the results are unbiased and fair.

How long will the study last for me?

You will be followed until a common end date for the study, which is expected to be about 12 months after the last person joins. Your individual participation time might vary.