Study on Edoxaban for Patients with Atrial Fibrillation and Previous Brain Bleeding

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What is this study about?

This clinical trial is focused on patients who have experienced a type of bleeding in the brain known as intracranial hemorrhage and also have a heart condition called atrial fibrillation. The study is investigating the effects of a medication called edoxaban, which is available in 60 mg and 30 mg doses as film-coated tablets. Edoxaban is a type of blood thinner that helps prevent blood clots. The purpose of the study is to determine if edoxaban can reduce the risk of stroke or other blood clot-related issues in these patients compared to those who are not taking any blood thinners or are on a different type of medication called antiplatelet therapy.

Participants in the study will be randomly assigned to receive either edoxaban or a placebo, which is a pill that looks like the medication but does not contain any active ingredients. The study will last for a period of 12 weeks, during which participants will take their assigned tablets daily. Throughout the study, participants will be monitored for any signs of stroke, blood clots, or bleeding events. The goal is to see if edoxaban is effective and safe for people with atrial fibrillation who have had a previous intracranial hemorrhage.

By participating in this study, researchers hope to gather important information that could help improve treatment options for patients with atrial fibrillation and a history of brain bleeding. The findings may lead to better ways to prevent strokes and other complications in this high-risk group of patients. The study is expected to be completed by April 2026.

1 joining the study

Upon joining the study, you will provide written informed consent, confirming your understanding and agreement to participate.

You must be at least 45 years old and have a history of a specific type of brain bleed, known as intracranial hemorrhage, and a condition called atrial fibrillation, which affects the heart’s rhythm.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility based on your medical history and current health status.

Your CHA2DS2-VASc score, which helps assess the risk of stroke, must be 2 or higher.

3 medication administration

You will be assigned to receive either edoxaban or a non-anticoagulant medical therapy. Edoxaban is taken orally in the form of film-coated tablets.

The dosage of edoxaban will be either 60 mg or 30 mg, taken once daily. The specific dosage will be determined by the study team.

4 ongoing monitoring

Throughout the study, regular monitoring will be conducted to assess your health and any effects of the medication.

This includes checking for any signs of stroke, systemic embolism, or major bleeding, which are key focus areas of the study.

5 follow-up visits

You will attend scheduled follow-up visits to evaluate your progress and any changes in your condition.

These visits will help track the effectiveness and safety of the treatment you are receiving.

6 completion of study

The study is expected to conclude by April 30, 2026. At the end of the study, a final assessment will be conducted.

The results will contribute to understanding the impact of edoxaban on reducing the risk of stroke and other complications in patients with your medical history.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate after understanding the study details.
Be 45 years or older at the time of signing the consent form.
Have had a previous intracranial hemorrhage, which is a type of bleeding inside the skull. This includes:
- Bleeding that was symptomatic (caused noticeable symptoms).
- Bleeding that was spontaneous (happened on its own) and non-traumatic (not caused by an injury).
- Bleeding that was non-lobar intraparenchymal (inside the brain tissue) or intraventricular (inside the brain’s fluid spaces).
- Bleeding that was symptomatic spontaneous or non-penetrating traumatic subdural (under the outer covering of the brain).
Have documented atrial fibrillation, which is a type of irregular heartbeat. This can be:
- Paroxysmal (comes and goes).
- Persistent (lasts longer than a week).
- Permanent (ongoing).
Have a CHA2DS2-VASc score of 2 or higher. This is a medical score used to determine the risk of stroke in people with atrial fibrillation.

Who Cannot Join the Study?

Patients who have a history of intracranial hemorrhage (bleeding inside the skull) cannot participate.
Patients who are not considered high risk for atrial fibrillation, as determined by a specific scoring system, are excluded.
Patients who are currently on anticoagulant therapy (medication that prevents blood clots) other than the study medication are not eligible.
Patients who are unable to take the study medication due to allergies or other medical reasons cannot join the study.
Patients with certain medical conditions that the study doctors believe would make participation unsafe are excluded.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who are part of another clinical trial at the same time are not eligible.
Patients who are unable to follow the study procedures or attend study visits are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University General Hospital of Patras, Department of Neurology	Patras	Greece
Hospital Jihlava	Jihlava	Czechia
Medical University Of Vienna	Vienna	Austria
Universitaetsmedizin Goettingen	Goettingen	Germany
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Cerebrovaskularni poradna s.r.o.	Moravska Ostrava A Privoz	Czechia
curiositas ad sanum Studien und Beratungs GmbH	Haag in Obb	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Ziekenhuis Oost Limburg	Genk	Belgium
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Charite Research Organisation GmbH	Berlin	Germany
Vrije Universiteit Brussel	Jette	Belgium
Jdlbt Hciblmxh	Hasselt	Belgium
Uzhtsbifxnpk Zmmskbneij Adiosllvi (jlxq	Edegem	Belgium
Gnlbzibns Hadyzmdx	Kortrijk	Belgium
Catvhyosysyrgyo osqcnofhbe csujfl (cgnt oq Nlnhytgmpz	Ostrava	Czechia
Kneimzvc Mvkuciejdopui	Lohr A. Main	Germany
Chkydf Hmtywgphvc Uqcvykcjyvzdh dh Lnkspji Cawuzws	Lisbon	Portugal
Krkpuxjd Fzqnskkansihegp Ggby	Friedrichshafen	Germany
Cmcefu Hjlqevsahg Ulcxomhokrldu De Pijtd Eknpmr	Porto	Portugal
Uilswblfwc Mjrocjg Cjjwmo Hqmjfjfdhuwcnhqfz	Hamburg	Germany
Ueyvuumjfmwkxykhaball Ecihf Ald	Essen	Germany
Uxunmucfyc Dkirv Sdofp Da Rzte Ln Srrafixb	Rome	Italy
Hinyuamb Vron dotbixps	Barcelona	Spain
Hymjrnkp Uncjcyxvyzcqv dc A Cvgvyb	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	24.09.2020
Belgium	Not yet recruiting	24.09.2020
Czechia	Not yet recruiting	24.09.2020
Denmark	Not yet recruiting	24.09.2020
Germany	Not yet recruiting	24.09.2020
Greece	Not yet recruiting	24.09.2020
Italy	Not yet recruiting	24.09.2020
Portugal	Not yet recruiting	24.09.2020
Slovakia	Not yet recruiting	24.09.2020
Spain	Not yet recruiting	24.09.2020

Trial locations

Investigated drugs:

Edoxaban

Edoxaban is a medication used in this clinical trial. It is a type of blood thinner, which means it helps prevent blood clots from forming in your body. This is important for people with atrial fibrillation, a condition where the heart beats irregularly, because they are at a higher risk of having a stroke. In this study, edoxaban is being tested to see if it can reduce the risk of stroke or other serious blood clot-related problems in people who have had a brain bleed in the past.

Nonanticoagulant medical therapy is another approach being studied in this trial. This means that instead of using blood thinners like edoxaban, participants may receive either no medication to prevent blood clots or a different type of medication called antiplatelet therapy. Antiplatelet therapy works by stopping blood cells called platelets from sticking together and forming clots. This option is being compared to edoxaban to see which is more effective at reducing the risk of stroke or other blood clot-related issues in people with atrial fibrillation who have previously experienced a brain bleed.

Investigated diseases:

Atrial Fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) beat out of coordination with the lower chambers (ventricles). This can lead to poor blood flow and the formation of blood clots in the heart. Over time, atrial fibrillation can cause symptoms such as palpitations, shortness of breath, and fatigue. The condition can be persistent or come and go, and it may increase the risk of stroke and other heart-related complications. It is often associated with other heart conditions and risk factors like high blood pressure and diabetes.

Trial ID:

2024-518508-31-00

Protocol code:

ENRICH-AF

NCT ID:

NCT03950076

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Edoxaban for Patients with Atrial Fibrillation and Previous Brain Bleeding

What is this study about?

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