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Can a blood thinner safely prevent strokes after a brain bleed?

NCT ID NCT03950076

Disease control Sponsor: Population Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study tests whether the blood thinner edoxaban can prevent strokes in people with atrial fibrillation (an irregular heartbeat) who have already survived a brain bleed. About 948 participants will receive either edoxaban or non-anticoagulant therapy (like aspirin or no blood thinners). The goal is to see if edoxaban reduces the risk of stroke or blood clots without causing another dangerous brain bleed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Edoxaban (a blood thinner, also known as Lixiana or Savaysa)
What this could lead to
If it works, this could offer a safer way to prevent strokes in people with atrial fibrillation who have already had a brain bleed, reducing their risk without causing another bleed.
What could go wrong
This is a phase 4 trial, but it's still uncertain whether edoxaban will be safer than avoiding blood thinners. There is a risk of major bleeding, including another brain bleed, which could outweigh the benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

948 people

The number who actually took part.

Started

Sep 2019

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent provided 2. Age ≥45 years, at the time of signing the informed consent 3. Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic non-lobar intraparenchymal or intraventricular hemorrhage, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy 4. Documented atrial fibrillation (paroxysmal, persistent, permanent) 5. CHA2DS2-VASc score ≥2 Exclusion Criteria: 1. Recent intracranial hemorrhage (within 14 days) 2. Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages) 3. Isolated subarachnoid hemorrhage (convexity or basal); subarachnoid blood tracking onto convexity secondary to an intraventricular hemorrhage or as part of a multicompartment bleed in cases of traumatic subdural hemorrhages are eligible 4. Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease) 5. Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute 6. Plans for left atrial appendage occlusion 7. Estimated creatinine clearance (CrCl) \< 15 mL/min 8. Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis 9. Persistent, uncontrolled hypertension (systolic BP averaging \>150 mmHg) 10. Chronic use of NSAID 11. Clinically significant active bleeding, including gastrointestinal bleeding 12. Lesions or conditions at increased risk of clinically significant bleeding, e.g. active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis 13. Antiphospholipid antibody syndrome 14. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk 15. Known hypersensitivity to edoxaban 16. Estimated inability to adhere to study procedures 17. Pregnancy or breastfeeding 18. Estimated life expectancy \< 6 months at the time of enrollment 19. Close affiliation with the investigational site; e.g. a close relative for the investigator, dependent person (e.g., employee or student of the investigational site) 20. Lobar intraparenchymal hemorrhage * Post menopausal female subjects must be amenorrheic for ≥12 months prior to screening or ≥6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to screening. Women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization or urine pregnancy testing within 24 hours of randomization. Heterosexually active women of childbearing potential must use highly effective methods of contraception for 32 days after discontinuation (duration of study drug plus 30 days duration of one ovulatory cycle).

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhagic Stroke intracerebral hemorrhage Intracranial Hemorrhages stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Intracranial hemorrhages

Contacts and locations

Locations

  • AZ Damiaan

    Ostend, Belgium

  • AZ Delta

    Roeselare, Belgium

  • Aberdeen Royal Infirmary, NHS Grampian

    Aberdeen, United Kingdom

  • Ain Shams Specialized Hospital

    Cairo, Egypt

  • Ain Shams University Hospital

    Cairo, Egypt

  • Alexandria University Hospital

    Alexandria, Egypt

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15218, United States

  • Annapurna Neurological institute and allied sciences

    Kathmandu, Nepal

  • Arrowe Park Hospital

    Birkenhead, United Kingdom

  • B & C Medical College Teaching Hospital & Research Centre Pvt. Ltd.

    Jhapa, Nepal

  • B P Koirala Institute of Health Sciences

    Dharān, Nepal

  • Bangalore Baptist Hospital

    Bangalore, India

  • Bangur Institute of Neurosciences

    Kolkata, India

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030, United States

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, China

  • Beni Suef University Hospital

    Banī Suwayf, Egypt

  • Bharati Vidyapeeth (DTU) Medical College & Hospital

    Pune, India

  • Bradford Teaching Hospitals NHS Foundation Trust, at Bradford Royal Infirmary

    Bradford, United Kingdom

  • Brandon Regional Health Centre

    Brandon, Canada

  • CHUL Pavillon Enfant-Jésus

    Québec, Canada

  • CHULN-Hospital Santa Maria

    Lisbon, Portugal

  • CHUM Centre Hospitalier de l'Université de Montréal

    Montreal, Canada

  • Calderdale and Huddersfield NHS Foundation Trust

    Huddersfield, United Kingdom

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, United Kingdom

  • Canadian Cardiac Research Centre

    Windsor, Canada

  • Caritas Hospital

    Kottayam, India

  • Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean

    Chicoutimi, Canada

  • Centro Instituto Neurologico Salta

    Salta, Argentina

  • Cerebrovaskularni poradna s.r.o.

    Ostrava, Czechia

  • Charité - University Medicine Berlin

    Berlin, Germany

  • Chitwan Everest Asptalal Private limited

    Bharatpur, Nepal

  • Chitwan Medical College Teaching Hospital

    Bharatpur, Nepal

  • Christian Medical College & Hospital

    Ludhiāna, India

  • Clinique CHC MontLégia

    Liège, Belgium

  • Complejo Hospitalario Universitario de Cáceres

    Cáceres, Spain

  • Coruña University Hospital

    A Coruña, Spain

  • Department of Neurology, Klinikum Vest

    Recklinghausen, Germany

  • Dhadiwal Hospital in coalition with Shreeji Healthcare

    Nashik, India

  • Dresden University Hospital "Carl Gustav Carus"

    Dresden, Germany

  • East Suffolk and North Essex NHS Foundation Trust, at Colchester Hospital

    Colchester, United Kingdom

  • Edinburgh Royal Infirmary

    Edinburgh, United Kingdom

  • Erasme Hospital

    Brussels, Belgium

  • Fayoum General Hospital

    Al Fayyum, Egypt

  • Fortis Hospital Ltd

    Bangalore, India

  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)

    Buenos Aires, C1428 CABA, Argentina

  • GNRC Hospitals

    Guwahati, India

  • Glasgow Royal Infirmary

    Glasgow, United Kingdom

  • Gloucestershire Royal Hospital

    Gloucester, United Kingdom

  • Grande International Hospital

    Kathmandu, Nepal

  • Groeninge Hospital

    Kortrijk, Belgium

  • Hamilton Health Sciences

    Hamilton, Canada

  • Hillingdon Hospital

    Uxbridge, United Kingdom

  • Homerton University Hospital

    London, United Kingdom

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Donostia - Osidonostialdea

    Donostia / San Sebastian, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Spain

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199 CABA, Argentina

  • Hospital Policial Churruca-Visca

    Buenos Aires, C1437 JCP, Argentina

  • Hospital Ramón y Cajal

    Madrid, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitari i Politécnic La Fe.

    Valencia, Spain

  • Hospital Universitario Central de Asturias-Finba

    Oviedo, Spain

  • Hospital Universitario son Espases

    Palma de Mallorca, Spain

  • Hospital de La Santa Creu Isant Pau

    Barcelona, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Hospital u Arnau de Vilanova de Lleida

    Lleida, Spain

  • Inselspital, University Hospital Bern

    Bern, Switzerland

  • Institut für Akutneurologie und Stroke Unit (IANS), Landeskrankenhaus Feldkirch

    Rankweil, Austria

  • Instituto de Investigacion Sanitaria Biocruces

    Barakaldo, Spain

  • Jessa Hospital

    Hasselt, Belgium

  • Kathmandu Medical College

    Kathmandu, Nepal

  • King's Mill Hospital

    Mansfield, United Kingdom

  • Kingston General Hospital

    Kingston, Canada

  • Klinik fur Neurologie, UKSH campus Lubeck

    Lübeck, Germany

  • Klinikum Friedrichshafen

    Friedrichshafen, Germany

  • Klinikum Main-Spessart, Krankenhaus Lohr

    Lohr, Germany

  • Klinikum Osnabrück; Neurologie

    Osnabrück, Germany

  • LNWUH - Northwick Park Hospital

    Harrow, United Kingdom

  • La Paz Univerity Hospital

    Madrid, Spain

  • London Health Science Centre - University Hospital

    London, Canada

  • Mansoura University Hospital

    Al Mansurah, Egypt

  • Martha-Maria Hospital

    Halle, Germany

  • Mazumdar Shaw Medical Center - Unit of Narayana Health

    Bangalore, India

  • McGill University Health Centre

    Montreal, Canada

  • Medical Faculty Mannheim, Heidelberg University

    Mannheim, Germany

  • Medical University of Innsbruck

    Innsbruck, Austria

  • Medical University of Vienna, Dept. of Neurology

    Vienna, Austria

  • Morriston Hospital

    Morriston, United Kingdom

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405, United States

  • NHS Lanarkshire Health Board - Monklands Hospital

    Airdrie, United Kingdom

  • Nanjappa Hospital

    Shimoga, India

  • Neurological Department, General Hospital of Jihlava

    Jihlava, Czechia

  • Nevill Hall Hospital

    Abergavenny, United Kingdom

  • New York Presbyterian - Queens

    Queens, New York, 11355, United States

  • Nobel Medical College & Teaching Hospital

    Biratnagar, Nepal

  • Nova Scotia Health Authority

    Halifax, Canada

  • Post Graduate Institute of Medical Education &Research

    Chandigarh, India

  • Presence Care Transformation Corporation

    Lisle, Illinois, 60532, United States

  • Punan Hospital

    Shanghai, China

  • Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust

    Gateshead, United Kingdom

  • Queen Elizabeth University Hospital

    Glasgow, United Kingdom

  • Rhythm Heart Institute

    Vadodara, India

  • Royal Berkshire NHS Foundation Trust

    Reading, United Kingdom

  • Royal Cornwall Hospital

    Truro, United Kingdom

  • Royal Preston Hospital

    Preston, United Kingdom

  • Salzkammergutklinikum Vöcklabruck

    Vöcklabruck, Austria

  • Shanghai Blue Cross Brain Hospital

    Shanghai, China

  • Shanghai East Hospital, Tongji University

    Shanghai, China

  • Shanghai Fengcheng Hospital

    Shanghai, China

  • Shree Krishna Hospital and Pramukhswami Medical College

    Anand, India

  • Sikkim Manipal Institute of Medical Sciences

    Gangtok, India

  • Southend University Hospital Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, United Kingdom

  • Sree Chitra Tirunal Institute for Medical Sciences and Technology

    Thiruvananthapuram, India

  • St. Anne's University Hospital

    Brno, Czechia

  • St. John's Medical College Hospital

    Bangalore, India

  • Stat Research S.A.

    Buenos Aires, C1023AAB, Argentina

  • Sunnybrook Health Science Centre

    Toronto, Canada

  • Tanta University Hospital

    Tanta, Egypt

  • Texas Tech University Health Sciences Center at El Paso

    El Paso, Texas, 79905, United States

  • The First People's Hospital of Shenyang

    Shenyang, China

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • The Ottawa Hospital Research Institute

    Ottawa, Canada

  • The Rhema Research Institute

    Owen Sound, Canada

  • The Royal Bournemouth Hospital

    Bournemouth, United Kingdom

  • The South Tees Hospitals NHS Foundation Trust

    Middlesbrough, United Kingdom

  • The University of Texas at Austin, Dell Medical School

    Austin, Texas, 78701, United States

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Canada

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112, United States

  • UZ Brussel

    Brussels, Belgium

  • UZ Leuven

    Leuven, Belgium

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem, Belgium

  • University Health Network - Toronto Western Hospital

    Toronto, Canada

  • University Hospital Basel

    Basel, Switzerland

  • University Hospital of Albacete

    Albacete, Spain

  • University Hospital of Wales

    Cardiff, United Kingdom

  • University Medicine Goettingen

    Goettigen, Germany

  • University of Alberta Hospital

    Edmonton, Canada

  • University of Calgary / Foothills Medical Centre

    Calgary, Canada

  • University of Saskatchewan

    Saskatoon, Canada

  • Universitätsklinikum Essen

    Essen, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum Tübingen

    Tübingen, Germany

  • Upendra Devkota Memorial-National Institute of Neurological and Allied Sciences (UDMNINAS)

    Kathmandu, Nepal

  • Victoria Hospital Kirkcaldy

    Kirkcaldy, United Kingdom

  • Westfalische Wilhelms-Universitat Munster

    Münster, Germany

  • Xinhua Hospital, Chongming Branch

    Shanghai, China

  • Yangpu Hospital, Tongji University

    Shanghai, China

  • Yeovil District Hospital

    Yeovil, United Kingdom

  • Zagazig University Hospital

    Zagazig, Egypt

  • Ziekenhuis Oost-Limburg

    Genk, Belgium

  • Zydus Hospitals & Healthcare Research Pvt. Ltd.

    Ahmedabad, India

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