EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
ENRICH-AF
1 other identifier
interventional
948
15 countries
152
Brief Summary
To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2019
Longer than P75 for phase_4
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedStudy Start
First participant enrolled
September 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 13, 2026
February 25, 2026
February 1, 2026
6.6 years
May 10, 2019
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stroke or Systemic Embolism
Stroke (composite of ischemic, hemorrhagic and unspecified) or systemic embolism
From randomization until the common study end date (average of 3 years)
Major hemorrhage
as defined byt the International Society on Thrombosis and Haemostasis (ISTH) criteria
From randomization until the common study end date (median 2 years)
Secondary Outcomes (11)
Ischemic stroke
From randomization until the common study end date (median 2 years)
Cardiovascular death
From randomization until the common study end date (median 2 years)
Hemorrhagic stroke
From randomization until the common study end date (median 2 years)
Disabling/fatal stroke
From randomization until the common study end date (median 2 years)
Composite of all stroke, myocardial infarction, systemic thromboembolism, or all-cause death
From randomization until the common study end date (median 2 years)
- +6 more secondary outcomes
Study Arms (2)
Edoxaban 60/30mg daily
EXPERIMENTALEdoxaban 60/30 mg daily (lower dose depending on clinical criteria)
Non-anticoagulant medical therapy
ACTIVE COMPARATORNon-anticoagulant medical therapy: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)
Interventions
Edoxaban 60mg (or 30mg as determined by clinical criteria)
Non-anticoagulant medical therapy as determined by the local investigator includes i) No antithrombotic therapy ii) Antiplatelet monotherapy, including de novo indication for antiplatelet monotherapy during course of the study
Eligibility Criteria
You may qualify if:
- Written informed consent provided
- Age ≥45 years, at the time of signing the informed consent
- 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
- Documented atrial fibrillation (paroxysmal, persistent, permanent)
- CHA2DS2-VASc score ≥2
You may not qualify if:
- Recent intracranial hemorrhage (within 14 days)
- Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
- 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
- Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
- Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
- Plans for left atrial appendage occlusion
- Estimated creatinine clearance (CrCl) \< 15 mL/min
- Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
- Persistent, uncontrolled hypertension (systolic BP averaging \>150 mmHg)
- Chronic use of NSAID
- Clinically significant active bleeding, including gastrointestinal bleeding
- 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
- Antiphospholipid antibody syndrome
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Known hypersensitivity to edoxaban
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (152)
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Presence Care Transformation Corporation
Lisle, Illinois, 60532, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
New York Presbyterian - Queens
Queens, New York, 11355, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15218, United States
The University of Texas at Austin, Dell Medical School
Austin, Texas, 78701, United States
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, 79905, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
Stat Research S.A.
Buenos Aires, C1023AAB, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199 CABA, Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires, C1428 CABA, Argentina
Hospital Policial Churruca-Visca
Buenos Aires, C1437 JCP, Argentina
Centro Instituto Neurologico Salta
Salta, Argentina
Medical University of Innsbruck
Innsbruck, Austria
Institut für Akutneurologie und Stroke Unit (IANS), Landeskrankenhaus Feldkirch
Rankweil, Austria
Medical University of Vienna, Dept. of Neurology
Vienna, Austria
Salzkammergutklinikum Vöcklabruck
Vöcklabruck, Austria
Erasme Hospital
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Jessa Hospital
Hasselt, Belgium
Groeninge Hospital
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
Clinique CHC MontLégia
Liège, Belgium
AZ Damiaan
Ostend, Belgium
AZ Delta
Roeselare, Belgium
Brandon Regional Health Centre
Brandon, Canada
University of Calgary / Foothills Medical Centre
Calgary, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, Canada
University of Alberta Hospital
Edmonton, Canada
Nova Scotia Health Authority
Halifax, Canada
Hamilton Health Sciences
Hamilton, Canada
Kingston General Hospital
Kingston, Canada
London Health Science Centre - University Hospital
London, Canada
CHUM Centre Hospitalier de l'Université de Montréal
Montreal, Canada
McGill University Health Centre
Montreal, Canada
The Ottawa Hospital Research Institute
Ottawa, Canada
The Rhema Research Institute
Owen Sound, Canada
CHUL Pavillon Enfant-Jésus
Québec, Canada
University of Saskatchewan
Saskatoon, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Canada
Sunnybrook Health Science Centre
Toronto, Canada
University Health Network - Toronto Western Hospital
Toronto, Canada
Canadian Cardiac Research Centre
Windsor, Canada
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Punan Hospital
Shanghai, China
Shanghai Blue Cross Brain Hospital
Shanghai, China
Shanghai East Hospital, Tongji University
Shanghai, China
Shanghai Fengcheng Hospital
Shanghai, China
Xinhua Hospital, Chongming Branch
Shanghai, China
Yangpu Hospital, Tongji University
Shanghai, China
The First People's Hospital of Shenyang
Shenyang, China
St. Anne's University Hospital
Brno, Czechia
Neurological Department, General Hospital of Jihlava
Jihlava, Czechia
Cerebrovaskularni poradna s.r.o.
Ostrava, Czechia
Fayoum General Hospital
Al Fayyum, Egypt
Mansoura University Hospital
Al Mansurah, Egypt
Alexandria University Hospital
Alexandria, Egypt
Beni Suef University Hospital
Banī Suwayf, Egypt
Ain Shams Specialized Hospital
Cairo, Egypt
Ain Shams University Hospital
Cairo, Egypt
Tanta University Hospital
Tanta, Egypt
Zagazig University Hospital
Zagazig, Egypt
Charité - University Medicine Berlin
Berlin, Germany
Dresden University Hospital "Carl Gustav Carus"
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum Friedrichshafen
Friedrichshafen, Germany
University Medicine Goettingen
Goettigen, Germany
Martha-Maria Hospital
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Klinikum Main-Spessart, Krankenhaus Lohr
Lohr, Germany
Klinik fur Neurologie, UKSH campus Lubeck
Lübeck, Germany
Medical Faculty Mannheim, Heidelberg University
Mannheim, Germany
Westfalische Wilhelms-Universitat Munster
Münster, Germany
Klinikum Osnabrück; Neurologie
Osnabrück, Germany
Department of Neurology, Klinikum Vest
Recklinghausen, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Zydus Hospitals & Healthcare Research Pvt. Ltd.
Ahmedabad, India
Shree Krishna Hospital and Pramukhswami Medical College
Anand, India
Bangalore Baptist Hospital
Bangalore, India
Fortis Hospital Ltd
Bangalore, India
Mazumdar Shaw Medical Center - Unit of Narayana Health
Bangalore, India
St. John's Medical College Hospital
Bangalore, India
Post Graduate Institute of Medical Education &Research
Chandigarh, India
Sikkim Manipal Institute of Medical Sciences
Gangtok, India
GNRC Hospitals
Guwahati, India
Bangur Institute of Neurosciences
Kolkata, India
Caritas Hospital
Kottayam, India
Christian Medical College & Hospital
Ludhiāna, India
Dhadiwal Hospital in coalition with Shreeji Healthcare
Nashik, India
Bharati Vidyapeeth (DTU) Medical College & Hospital
Pune, India
Nanjappa Hospital
Shimoga, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, India
Rhythm Heart Institute
Vadodara, India
Chitwan Everest Asptalal Private limited
Bharatpur, Nepal
Chitwan Medical College Teaching Hospital
Bharatpur, Nepal
Nobel Medical College & Teaching Hospital
Biratnagar, Nepal
B P Koirala Institute of Health Sciences
Dharān, Nepal
B & C Medical College Teaching Hospital & Research Centre Pvt. Ltd.
Jhapa, Nepal
Annapurna Neurological institute and allied sciences
Kathmandu, Nepal
Grande International Hospital
Kathmandu, Nepal
Kathmandu Medical College
Kathmandu, Nepal
Upendra Devkota Memorial-National Institute of Neurological and Allied Sciences (UDMNINAS)
Kathmandu, Nepal
CHULN-Hospital Santa Maria
Lisbon, Portugal
Coruña University Hospital
A Coruña, Spain
University Hospital of Albacete
Albacete, Spain
Instituto de Investigacion Sanitaria Biocruces
Barakaldo, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de La Santa Creu Isant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Complejo Hospitalario Universitario de Cáceres
Cáceres, Spain
Hospital Donostia - Osidonostialdea
Donostia / San Sebastian, Spain
Hospital u Arnau de Vilanova de Lleida
Lleida, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
La Paz Univerity Hospital
Madrid, Spain
Hospital Universitario Central de Asturias-Finba
Oviedo, Spain
Hospital Universitario son Espases
Palma de Mallorca, Spain
Hospital Universitari i Politécnic La Fe.
Valencia, Spain
University Hospital Basel
Basel, Switzerland
Inselspital, University Hospital Bern
Bern, Switzerland
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, United Kingdom
Nevill Hall Hospital
Abergavenny, United Kingdom
NHS Lanarkshire Health Board - Monklands Hospital
Airdrie, United Kingdom
Arrowe Park Hospital
Birkenhead, United Kingdom
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust, at Bradford Royal Infirmary
Bradford, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
East Suffolk and North Essex NHS Foundation Trust, at Colchester Hospital
Colchester, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
LNWUH - Northwick Park Hospital
Harrow, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom
Victoria Hospital Kirkcaldy
Kirkcaldy, United Kingdom
Homerton University Hospital
London, United Kingdom
King's Mill Hospital
Mansfield, United Kingdom
The South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom
Morriston Hospital
Morriston, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Hillingdon Hospital
Uxbridge, United Kingdom
Southend University Hospital Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, United Kingdom
Yeovil District Hospital
Yeovil, United Kingdom
Related Publications (2)
Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
PMID: 36700520DERIVEDLi L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.
PMID: 34022170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashkan Shoamanesh, MD, FRCPC
Population Health Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- open label study where outcomes assessor is blinded to treatment allocation
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2019
First Posted
May 15, 2019
Study Start
September 20, 2019
Primary Completion (Estimated)
May 13, 2026
Study Completion (Estimated)
May 13, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02