EdoxabaN for IntraCranial Hemorrhage Survivors with Atrial Fibrillation (ENRICH-AF)
NCT ID: NCT03950076
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
948 participants
INTERVENTIONAL
2019-09-20
2026-10-31
Brief Summary
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Detailed Description
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ENRICH-AF will assess the safety and efficacy of anticoagulant therapy in AF participants after intracranial hemorrhage, an area where there currently exists huge interest within the stroke and cardiology research communities. Demonstrating safety comparable with non-anticoagulant medical therapy in AF patients who are particularly at high risk for intracranial hemorrhage is likely to have a more far-reaching clinical impact than solely within the proposed study population. ENRICH-AF will be the "ultimate safety test" of anticoagulation of AF patients, providing reassuring evidence favoring more widespread use of anticoagulation for stroke prevention in AF patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Edoxaban 60/30mg daily
Edoxaban 60/30 mg daily (lower dose depending on clinical criteria)
Edoxaban
Edoxaban 60mg (or 30mg as determined by clinical criteria)
Non-anticoagulant medical therapy
Non-anticoagulant medical therapy: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)
Non-anticoagulant medical therapy
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
Interventions
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Edoxaban
Edoxaban 60mg (or 30mg as determined by clinical criteria)
Non-anticoagulant medical therapy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
45 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Ashkan Shoamanesh, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Locations
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Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Presence Care Transformation Corporation
Lisle, Illinois, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
New York Presbyterian - Queens
Queens, New York, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
The University of Texas at Austin, Dell Medical School
Austin, Texas, United States
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, United States
Baylor St. Luke's Medical Center
Houston, Texas, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Stat Research S.A.
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires, , Argentina
Hospital Policial Churruca-Visca
Buenos Aires, , 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
Countries
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References
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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.
Li 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.
Other Identifiers
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ENRICH-AF
Identifier Type: -
Identifier Source: org_study_id
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