EdoxabaN for IntraCranial Hemorrhage Survivors with Atrial Fibrillation (ENRICH-AF)
Who is this study for? High-risk patients with atrial fibrillation with previous intracranial hemorrhage
Status: Active_not_recruiting
Location: See all (149) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Alexian Brothers Medical Center
Elk Grove Village
Presence Care Transformation Corporation
Lisle
Louisiana
Tulane University Medical Center
New Orleans
New York
New York Presbyterian - Queens
Queens
Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia
Allegheny General Hospital
Pittsburgh
Texas
The University of Texas at Austin, Dell Medical School
Austin
Texas Tech University Health Sciences Center at El Paso
El Paso
Baylor St. Luke's Medical Center
Houston
Washington
MultiCare Institute for Research & Innovation
Tacoma
Other Locations
Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Hospital Policial Churruca-Visca
Buenos Aires
Stat Research S.A.
Buenos Aires
Centro Instituto Neurologico Salta
Salta
Austria
Medical University of Innsbruck
Innsbruck
Institut für Akutneurologie und Stroke Unit (IANS), Landeskrankenhaus Feldkirch
Rankweil
Medical University of Vienna, Dept. of Neurology
Vienna
Salzkammergutklinikum Vöcklabruck
Vocklabruck
Belgium
Erasme Hospital
Brussel
UZ Brussel
Brussel
Universitair Ziekenhuis Antwerpen (UZA)
Edegem
Ziekenhuis Oost-Limburg
Genk
Jessa Hospital
Hasselt
Groeninge Hospital
Kortrijk
UZ Leuven
Leuven
Clinique CHC MontLégia
Liège
AZ Damiaan
Oostende
AZ Delta
Roeselare
Canada
Brandon Regional Health Centre
Brandon
University of Calgary / Foothills Medical Centre
Calgary
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi
University of Alberta Hospital
Edmonton
Nova Scotia Health Authority
Halifax
Hamilton Health Sciences
Hamilton
Kingston General Hospital
Kingston
London Health Science Centre - University Hospital
London
CHUM Centre Hospitalier de l'Université de Montréal
Montreal
McGill University Health Centre
Montréal
The Ottawa Hospital Research Institute
Ottawa
The Rhema Research Institute
Owen Sound
CHUL Pavillon Enfant-Jésus
Québec
University of Saskatchewan
Saskatoon
Thunder Bay Regional Health Sciences Centre
Thunder Bay
Sunnybrook Health Science Centre
Toronto
University Health Network - Toronto Western Hospital
Toronto
Canadian Cardiac Research Centre
Windsor
China
Beijing Anzhen Hospital, Capital Medical University
Beijing
Punan Hospital
Shanghai
Shanghai Blue Cross Brain Hospital
Shanghai
Shanghai East Hospital, Tongji University
Shanghai
Shanghai Fengcheng Hospital
Shanghai
Xinhua Hospital, Chongming Branch
Shanghai
Yangpu Hospital, Tongji University
Shanghai
The First People's Hospital of Shenyang
Shenyang
Egypt
Alexandria University Hospital
Alexandria
Beni Suef University Hospital
Banī Suwayf
Ain Shams Specialized Hospital
Cairo
Ain Shams University Hospital
Cairo
Fayoum General Hospital
Fayoum
Mansoura University Hospital
Mansoura
Tanta University Hospital
Tanta
Zagazig University Hospital
Zagazig
Germany
Charité - University Medicine Berlin
Berlin
Dresden University Hospital Carl Gustav Carus
Dresden
Universitätsklinikum Essen
Essen
Klinikum Friedrichshafen
Friedrichshafen
University Medicine Goettingen
Goettigen
Martha-Maria Hospital
Halle
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Klinikum Main-Spessart, Krankenhaus Lohr
Lohr
Klinik fur Neurologie, UKSH campus Lubeck
Lübeck
Medical Faculty Mannheim, Heidelberg University
Mannheim
Westfalische Wilhelms-Universitat Munster
Münster
Klinikum Osnabrück; Neurologie
Osnabrück
Department of Neurology, Klinikum Vest
Recklinghausen
Universitätsklinikum Tübingen
Tuebingen
India
Zydus Hospitals & Healthcare Research Pvt. Ltd.
Ahmedabad
Shree Krishna Hospital and Pramukhswami Medical College
Anand
Bangalore Baptist Hospital
Bangalore
Fortis Hospital Ltd
Bangalore
Mazumdar Shaw Medical Center - Unit of Narayana Health
Bangalore
St. John's Medical College Hospital
Bangalore
Post Graduate Institute of Medical Education &Research
Chandigarh
Sikkim Manipal Institute of Medical Sciences
Gangtok
GNRC Hospitals
Guwahati
Bangur Institute of Neurosciences
Kolkata
Caritas Hospital
Kottayam
Christian Medical College & Hospital
Ludhiāna
Dhadiwal Hospital in coalition with Shreeji Healthcare
Nashik
Bharati Vidyapeeth (DTU) Medical College & Hospital
Pune
Nanjappa Hospital
Shimoga
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
Rhythm Heart Institute
Vadodara
Nepal
Chitwan Everest Asptalal Private limited
Bharatpur
Chitwan Medical College Teaching Hospital
Bharatpur
Nobel Medical College & Teaching Hospital
Biratnagar
B P Koirala Institute of Health Sciences
Dharān Bāzār
B & C Medical College Teaching Hospital & Research Centre Pvt. Ltd.
Jhapa
Annapurna Neurological institute and allied sciences
Kathmandu
Grande International Hospital
Kathmandu
Kathmandu Medical College
Kathmandu
Upendra Devkota Memorial-National Institute of Neurological and Allied Sciences (UDMNINAS)
Kathmandu
Portugal
CHULN-Hospital Santa Maria
Lisboa
Spain
Coruña University Hospital
A Coruña
University Hospital of Albacete
Albacete
Instituto de Investigacion Sanitaria Biocruces
Barakaldo
Hospital Clinic de Barcelona
Barcelona
Hospital de La Santa Creu Isant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Complejo Hospitalario Universitario de Cáceres
Cáceres
Hospital Donostia - Osidonostialdea
Donostia
Hospital u Arnau de Vilanova de Lleida
Lleida
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Ramón y Cajal
Madrid
La Paz Univerity Hospital
Madrid
Hospital Universitario Central de Asturias-Finba
Oviedo
Hospital Universitario son Espases
Palma De Mallorca
Hospital Universitari i Politécnic La Fe.
Valencia
Switzerland
University Hospital Basel
Basel
Inselspital, University Hospital Bern
Bern
United Kingdom
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen
Nevill Hall Hospital
Abergavenny
NHS Lanarkshire Health Board - Monklands Hospital
Airdrie
Arrowe Park Hospital
Birkenhead
The Royal Bournemouth Hospital
Bournemouth
Bradford Teaching Hospitals NHS Foundation Trust, at Bradford Royal Infirmary
Bradford
Cambridge University Hospitals NHS Foundation Trust
Cambridge
University Hospital of Wales
Cardiff
East Suffolk and North Essex NHS Foundation Trust, at Colchester Hospital
Colchester
Edinburgh Royal Infirmary
Edinburgh
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust
Gateshead
Glasgow Royal Infirmary
Glasgow
Queen Elizabeth University Hospital
Glasgow
Gloucestershire Royal Hospital
Gloucester
LNWUH - Northwick Park Hospital
Harrow
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield
Victoria Hospital Kirkcaldy
Kirkcaldy
Homerton University Hospital
London
King's Mill Hospital
Mansfield
The South Tees Hospitals NHS Foundation Trust
Middlesbrough
Morriston Hospital
Morriston
Royal Preston Hospital
Preston
Royal Berkshire NHS Foundation Trust
Reading
Royal Cornwall Hospital
Truro
Hillingdon Hospital
Uxbridge
Southend University Hospital Southend University Hospital NHS Foundation Trust
Westcliff-on-sea
Yeovil District Hospital
Yeovil
Time Frame
Start Date: 2019-09-20
Completion Date: 2026-10
Participants
Target number of participants: 948
Treatments
Experimental: Edoxaban 60/30mg daily
Edoxaban 60/30 mg daily (lower dose depending on clinical criteria)
Active_comparator: Non-anticoagulant medical therapy
Non-anticoagulant medical therapy: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)
Authors
Evangelos Vasileiadis, Franklin Marden, Aleksandra Pikula, Justin Salerian, Konark Malhotra, Feliks Koyfman, Arvind Sharma, Dheeraj Khurana, Kaiz Asif, Stephen Phillips, Hawraman Ramadan, Keith Muir, Jan Beyer-Westendorf, Martin Kohrmann, Jens Minnerup, Matthias Endres, Vera Cvoro, Roman Huber, Jan Liman, Sven Poli, Georg Royl, Rustam Al-Shahi Salman, Rudiger Hilker-Roggendorf, Goetz Thomalla, Mary Joan Macleod, Paul Guyler, Jon Ween, Arturo Tamayo, Kaushik Rana, Shirin Jalini, Hany Aref, Raj Bathula, Kim Bekelaar, Bidita Khandelwal, Joseph Sebastian, Alok Dahal, Ignacio Casado-Naranjo, Wadea Tarhuni, Amit Thapa, Sankar Prasad Gorthi, Tom Hughes, Yunhua Yue, Soaham Desai, Ayman Hassan, Sam Schulman, Thomas Mathew, Angelika Alonso, Kelvin Ng, Mar Castellanos, Ronny Beer, Joan Marti-Fabregas, Brett Graham, Carlos Molina, Ana Rodriguez-Campello, Alexander Khaw, Nomal Chandra Borah, Biman Kanti Ray, Jens Eckstein, Vikram Huded, Steve Verreault, Jeyaraj D Pandian, Robin Lemmens, Noémie Ligot, Tamer Belal, Padmavathy Narayanan Sylaja, Laura Gioia, Caroline Loos, Sylvie De Raedt, Peter Vanacker, Terry Quinn, Philippe Desfontaines, Eoin OBrien, David Seiffge, Dar Dowlatshahi, Robert Mikulik, Jaime Masjuan, Patricia Canhão
Related Therapeutic Areas
Sponsors
Leads: Population Health Research Institute