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EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF) (ENRICH-AF)

Primary Purpose

Intracranial Hemorrhages, Atrial Fibrillation

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Edoxaban
Non-anticoagulant medical therapy
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Hemorrhages focused on measuring Edoxaban, Intracranial Hemorrhage, Hemorrhagic Stroke

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 intraparenchymal, intraventricular, and/or cSAH, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy, and confirmed to have stabilized on neuroimaging.
  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. Traumatic or aneurysmal cSAH
  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 or other creatinine clearance following local product monograph (Canada < 30mL/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)

    • 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).

Sites / Locations

  • Alexian Brothers Medical CenterRecruiting
  • Presence Care Transformation CorporationRecruiting
  • Tulane University Medical CenterRecruiting
  • New York Presbyterian - QueensRecruiting
  • The Hospital of the University of PennsylvaniaRecruiting
  • Allegheny General HospitalRecruiting
  • The University of Texas at Austin, Dell Medical SchoolRecruiting
  • Texas Tech University Health Sciences Center at El PasoRecruiting
  • Baylor St. Luke's Medical CenterRecruiting
  • MultiCare Institute for Research & InnovationRecruiting
  • Stat Research S.A.Recruiting
  • Hospital Italiano de Buenos AiresRecruiting
  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)Recruiting
  • Hospital Policial Churruca-ViscaRecruiting
  • Centro Instituto Neurologico SaltaRecruiting
  • Medical University of InnsbruckRecruiting
  • Institut für Akutneurologie und Stroke Unit (IANS), Landeskrankenhaus FeldkirchRecruiting
  • Medical University of Vienna, Dept. of NeurologyRecruiting
  • Salzkammergutklinikum VöcklabruckRecruiting
  • Erasme HospitalRecruiting
  • UZ BrusselRecruiting
  • Universitair Ziekenhuis Antwerpen (UZA)Recruiting
  • Ziekenhuis Oost-LimburgRecruiting
  • Jessa HospitalRecruiting
  • Groeninge HospitalRecruiting
  • UZ LeuvenRecruiting
  • Clinique CHC MontLégiaRecruiting
  • AZ DamiaanRecruiting
  • AZ DeltaRecruiting
  • Brandon Regional Health CentreRecruiting
  • University of Calgary / Foothills Medical CentreRecruiting
  • Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-JeanRecruiting
  • University of Alberta HospitalRecruiting
  • Nova Scotia Health AuthorityRecruiting
  • Hamilton Health SciencesRecruiting
  • Hamilton Health SciencesRecruiting
  • Kingston General HospitalRecruiting
  • London Health Science Centre - University HospitalRecruiting
  • CHUM Centre Hospitalier de l'Université de MontréalRecruiting
  • McGill University Health CentreRecruiting
  • The Ottawa Hospital Research InstituteRecruiting
  • The Rhema Research InstituteRecruiting
  • CHUL Pavillon Enfant-JésusRecruiting
  • University of SaskatchewanRecruiting
  • Thunder Bay Regional Health Sciences CentreRecruiting
  • Sunnybrook Health Science CentreRecruiting
  • University Health Network - Toronto Western HospitalRecruiting
  • Canadian Cardiac Research CentreRecruiting
  • Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
  • Punan HospitalRecruiting
  • Shanghai Blue Cross Brain HospitalRecruiting
  • Shanghai East Hospital, Tongji UniversityRecruiting
  • Shanghai Fengcheng HospitalRecruiting
  • Xinhua Hospital, Chongming BranchRecruiting
  • Yangpu Hospital, Tongji UniversityRecruiting
  • The First People's Hospital of ShenyangRecruiting
  • St. Anne's University HospitalRecruiting
  • Neurological Department, General Hospital of JihlavaRecruiting
  • Cerebrovaskularni poradna s.r.o.Recruiting
  • Alexandria University HospitalRecruiting
  • Beni Suef University HospitalRecruiting
  • Ain Shams Specialized HospitalRecruiting
  • Ain Shams University HospitalRecruiting
  • Fayoum General HospitalRecruiting
  • Mansoura University HospitalRecruiting
  • Tanta University HospitalRecruiting
  • Zagazig University HospitalRecruiting
  • Charité - University Medicine BerlinRecruiting
  • Dresden University Hospital "Carl Gustav Carus"Recruiting
  • Universitätsklinikum EssenRecruiting
  • Klinikum FriedrichshafenRecruiting
  • University Medicine GoettingenRecruiting
  • Martha-Maria HospitalRecruiting
  • Universitätsklinikum Hamburg-EppendorfRecruiting
  • Klinikum Main-Spessart, Krankenhaus LohrRecruiting
  • Klinik fur Neurologie, UKSH campus LubeckRecruiting
  • Medical Faculty Mannheim, Heidelberg UniversityRecruiting
  • Westfalische Wilhelms-Universitat MunsterRecruiting
  • Klinikum Osnabrück; NeurologieRecruiting
  • Department of Neurology, Klinikum VestRecruiting
  • Universitätsklinikum TübingenRecruiting
  • Zydus Hospitals & Healthcare Research Pvt. Ltd.Recruiting
  • Shree Krishna Hospital and Pramukhswami Medical CollegeRecruiting
  • Bangalore Baptist HospitalRecruiting
  • Fortis Hospital LtdRecruiting
  • Mazumdar Shaw Medical Center - Unit of Narayana HealthRecruiting
  • St. John's Medical College HospitalRecruiting
  • Post Graduate Institute of Medical Education &ResearchRecruiting
  • Sikkim Manipal Institute of Medical SciencesRecruiting
  • GNRC HospitalsRecruiting
  • Bangur Institute of NeurosciencesRecruiting
  • Caritas HospitalRecruiting
  • Christian Medical College & HospitalRecruiting
  • Dhadiwal Hospital in coalition with Shreeji HealthcareRecruiting
  • Bharati Vidyapeeth (DTU) Medical College & HospitalRecruiting
  • Nanjappa HospitalRecruiting
  • Sree Chitra Tirunal Institute for Medical Sciences and TechnologyRecruiting
  • Rhythm Heart InstituteRecruiting
  • Chitwan Everest Asptalal Private limitedRecruiting
  • Chitwan Medical College Teaching HospitalRecruiting
  • Nobel Medical College & Teaching HospitalRecruiting
  • B P Koirala Institute of Health SciencesRecruiting
  • B & C Medical College Teaching Hospital & Research Centre Pvt. Ltd.Recruiting
  • Annapurna Neurological institute and allied sciencesRecruiting
  • Grande International HospitalRecruiting
  • Kathmandu Medical CollegeRecruiting
  • Upendra Devkota Memorial-National Institute of Neurological and Allied Sciences (UDMNINAS)Recruiting
  • CHULN-Hospital Santa MariaRecruiting
  • Coruña University HospitalRecruiting
  • University Hospital of AlbaceteRecruiting
  • Instituto de Investigacion Sanitaria BiocrucesRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital de La Santa Creu Isant PauRecruiting
  • Hospital del MarRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Complejo Hospitalario Universitario de CáceresRecruiting
  • Hospital Donostia - OsidonostialdeaRecruiting
  • Hospital u Arnau de Vilanova de LleidaRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Ramón y CajalRecruiting
  • La Paz Univerity HospitalRecruiting
  • Hospital Universitario Central de Asturias-FinbaRecruiting
  • Hospital Universitario son EspasesRecruiting
  • Hospital Universitari i Politécnic La Fe.Recruiting
  • University Hospital BaselRecruiting
  • Inselspital, University Hospital BernRecruiting
  • Aberdeen Royal Infirmary, NHS GrampianRecruiting
  • Nevill Hall HospitalRecruiting
  • NHS Lanarkshire Health Board - Monklands HospitalRecruiting
  • Arrowe Park HospitalRecruiting
  • The Royal Bournemouth HospitalRecruiting
  • Bradford Teaching Hospitals NHS Foundation Trust, at Bradford Royal InfirmaryRecruiting
  • Cambridge University Hospitals NHS Foundation TrustRecruiting
  • University Hospital of WalesRecruiting
  • East Suffolk and North Essex NHS Foundation Trust, at Colchester HospitalRecruiting
  • Edinburgh Royal InfirmaryRecruiting
  • Queen Elizabeth Hospital - Gateshead Health NHS Foundation TrustRecruiting
  • Glasgow Royal InfirmaryRecruiting
  • Queen Elizabeth University HospitalRecruiting
  • Gloucestershire Royal HospitalRecruiting
  • LNWUH - Northwick Park HospitalRecruiting
  • Calderdale and Huddersfield NHS Foundation TrustRecruiting
  • Victoria Hospital KirkcaldyRecruiting
  • Homerton University HospitalRecruiting
  • King's Mill HospitalRecruiting
  • The South Tees Hospitals NHS Foundation TrustRecruiting
  • Morriston HospitalRecruiting
  • Royal Preston HospitalRecruiting
  • Royal Berkshire NHS Foundation TrustRecruiting
  • Royal Cornwall HospitalRecruiting
  • Hillingdon HospitalRecruiting
  • Southend University Hospital Southend University Hospital NHS Foundation TrustRecruiting
  • Yeovil District HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban 60/30mg daily

Non-anticoagulant medical therapy

Arm Description

Edoxaban 60/30 mg daily (lower dose depending on clinical criteria)

Non-anticoagulant medical therapy: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)

Outcomes

Primary Outcome Measures

Stroke
composite of ischemic, hemorrhagic and unspecified
Major hemorrhage
as defined byt the International Society on Thrombosis and Haemostasis (ISTH) criteria

Secondary Outcome Measures

Ischemic stroke
development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute ischemic stroke.
Cardiovascular death
Death related to cardiovascular cause
Hemorrhagic stroke
development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute intraparenchymal, intraventricular or subarachnoid hemorrhage
Disabling/fatal stroke
Disabling stroke is defined as stroke resulting in a clinical outcome that is associated with a modified Rankin scale of 4 or 5. Fatal stroke is defined as death occurring within 30 days of stroke.
Composite of all stroke, myocardial infarction, systemic thromboembolism, or all-cause death
Components of composite outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging),myocardial infarction, systemic thromboembolism or all-cause death. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred
Net clinical benefit (composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area)
Net clinical benefit is a composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area
modified Rankin Scale
mRS as measured at 12 month visit
All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage)
Intracranial hemorrhage as defined by Signs or symptoms associated with an epidural, subdural, subarachnoid, intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy.
Fatal intracranial hemorrhage
Inctracranial hemorrhage defined as Signs or symptoms associated with an epidural, subdural, subarachnoid, intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy with death occurring within 30 days of stroke
Subdural hemorrhage
Subdural hemorrhage as defined as Signs or symptoms associated with a subdural hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy
Hospitalization for any cause
Minimum of one overnight stay in hospital.

Full Information

First Posted
May 10, 2019
Last Updated
January 23, 2023
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03950076
Brief Title
EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
Acronym
ENRICH-AF
Official Title
EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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) in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.
Detailed Description
The EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation (ENRICH-AF) study is a prospective, randomized open-label, blinded end-point (PROBE), investigator-initiated, study that will define the efficacy and safety of edoxaban compared with non-anticoagulant medical therapy (no antithrombotic therapy or antiplatelet monotherapy) for stroke prevention in high-risk AF patients and previous intracranial hemorrhage. Intracranial hemorrhage includes intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage and subdural hematoma. Recruitment will occur at 250-300 stroke research centres in North and South America, Europe and Asia over 24 months, where 1200 adult participants with high-risk AF (CHA2DS2-VASc score ≥2) and previous spontaneous or traumatic intracranial hemorrhage (while on or off antithrombotic therapy) will be randomly assigned to receive edoxaban 60/30 mg daily or to non-anticoagulant medical therapy (no antithrombotic therapy or antiplatelet monotherapy). Consenting participants will be followed to a common study end-date in this event-driven trial once 123 primary efficacy events (stroke) have accrued; anticipated to be about 12 months after the end of recruitment. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hemorrhages, Atrial Fibrillation
Keywords
Edoxaban, Intracranial Hemorrhage, Hemorrhagic Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, open, blinded end-point (PROBE), multicenter international trial
Masking
Outcomes Assessor
Masking Description
open label study where outcomes assessor is blinded to treatment allocation
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban 60/30mg daily
Arm Type
Experimental
Arm Description
Edoxaban 60/30 mg daily (lower dose depending on clinical criteria)
Arm Title
Non-anticoagulant medical therapy
Arm Type
Active Comparator
Arm Description
Non-anticoagulant medical therapy: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Lixiana, Savaysa
Intervention Description
Edoxaban 60mg (or 30mg as determined by clinical criteria)
Intervention Type
Other
Intervention Name(s)
Non-anticoagulant medical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Stroke
Description
composite of ischemic, hemorrhagic and unspecified
Time Frame
From randomization until the common study end date (median 2 years)
Title
Major hemorrhage
Description
as defined byt the International Society on Thrombosis and Haemostasis (ISTH) criteria
Time Frame
From randomization until the common study end date (median 2 years)
Secondary Outcome Measure Information:
Title
Ischemic stroke
Description
development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute ischemic stroke.
Time Frame
From randomization until the common study end date (median 2 years)
Title
Cardiovascular death
Description
Death related to cardiovascular cause
Time Frame
From randomization until the common study end date (median 2 years)
Title
Hemorrhagic stroke
Description
development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute intraparenchymal, intraventricular or subarachnoid hemorrhage
Time Frame
From randomization until the common study end date (median 2 years)
Title
Disabling/fatal stroke
Description
Disabling stroke is defined as stroke resulting in a clinical outcome that is associated with a modified Rankin scale of 4 or 5. Fatal stroke is defined as death occurring within 30 days of stroke.
Time Frame
From randomization until the common study end date (median 2 years)
Title
Composite of all stroke, myocardial infarction, systemic thromboembolism, or all-cause death
Description
Components of composite outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging),myocardial infarction, systemic thromboembolism or all-cause death. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred
Time Frame
From randomization until the common study end date (median 2 years)
Title
Net clinical benefit (composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area)
Description
Net clinical benefit is a composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area
Time Frame
From randomization until the common study end date (median 2 years)
Title
modified Rankin Scale
Description
mRS as measured at 12 month visit
Time Frame
12 months
Title
All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage)
Description
Intracranial hemorrhage as defined by Signs or symptoms associated with an epidural, subdural, subarachnoid, intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy.
Time Frame
From randomization until the common study end date (median 2 years)
Title
Fatal intracranial hemorrhage
Description
Inctracranial hemorrhage defined as Signs or symptoms associated with an epidural, subdural, subarachnoid, intraparenchymal or intraventricular hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy with death occurring within 30 days of stroke
Time Frame
From randomization until the common study end date (median 2 years)
Title
Subdural hemorrhage
Description
Subdural hemorrhage as defined as Signs or symptoms associated with a subdural hemorrhage on computed tomography (CT) or MRI scan, or as demonstrated by surgery or autopsy
Time Frame
From randomization until the common study end date (median 2 years)
Title
Hospitalization for any cause
Description
Minimum of one overnight stay in hospital.
Time Frame
From randomization until the common study end date (median 2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent provided Age ≥45 years, at the time of signing the informed consent Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic intraparenchymal, intraventricular, and/or cSAH, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy, and confirmed to have stabilized on neuroimaging. Documented atrial fibrillation (paroxysmal, persistent, permanent) CHA2DS2-VASc score ≥2 Exclusion Criteria: 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) Traumatic or aneurysmal cSAH 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 or other creatinine clearance following local product monograph (Canada < 30mL/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 Estimated inability to adhere to study procedures Pregnancy or breastfeeding Estimated life expectancy < 6 months at the time of enrollment 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) 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Reeh, MSc
Phone
905-521-2100
Ext
40665
Email
ENRICH-AF@phri.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Taylor, BSc
Phone
905-521-2100
Ext
40508
Email
ENRICH-AF@phri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashkan Shoamanesh, MD. FRCPC
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franklin Marden, MD
Facility Name
Presence Care Transformation Corporation
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiz Asif, MD
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Salerian, MD
Facility Name
New York Presbyterian - Queens
City
Queens
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feliks Koyfman, MD
Facility Name
The Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristy Yuan, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konark Malhotra, MD
Facility Name
The University of Texas at Austin, Dell Medical School
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Truman Jr Milling, MD
Facility Name
Texas Tech University Health Sciences Center at El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cruz-Flores Salvador, MD
Facility Name
Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chethan P Venkatasubba Rao, MD
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Ween, MD
Facility Name
Stat Research S.A.
City
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conrado Estol, MD, PhD
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1199 CABA
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Balian, MD
Facility Name
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
City
Buenos Aires
ZIP/Postal Code
C1428 CABA
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Ameriso, MD
Facility Name
Hospital Policial Churruca-Visca
City
Buenos Aires
ZIP/Postal Code
C1437 JCP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Povedano, MD
Facility Name
Centro Instituto Neurologico Salta
City
Salta
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Herrera, MD
Facility Name
Medical University of Innsbruck
City
Innsbruck
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronny Beer, MD
Facility Name
Institut für Akutneurologie und Stroke Unit (IANS), Landeskrankenhaus Feldkirch
City
Rankweil
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Werner, MD
Facility Name
Medical University of Vienna, Dept. of Neurology
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Greisnegger, MD
Facility Name
Salzkammergutklinikum Vöcklabruck
City
Vocklabruck
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nenad Mitrovic, MD
Facility Name
Erasme Hospital
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noémie Ligot, MD
Facility Name
UZ Brussel
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie De Raedt, MD
Facility Name
Universitair Ziekenhuis Antwerpen (UZA)
City
Edegem
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Loos, MD
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Bekelaar, MD
Facility Name
Jessa Hospital
City
Hasselt
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina De Klippel, MD
Facility Name
Groeninge Hospital
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Vanacker, MD
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Lemmens, MD
Facility Name
Clinique CHC MontLégia
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Desfontaines, MD
Facility Name
AZ Damiaan
City
Oostende
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adinda De Pauw, MD
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Christine Hasenbroekx, MD
Facility Name
Brandon Regional Health Centre
City
Brandon
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arturo Tamayo, MD
Facility Name
University of Calgary / Foothills Medical Centre
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Smith, MD
Facility Name
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
City
Chicoutimi
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Beaudry, MD
Facility Name
University of Alberta Hospital
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Buck, MD
Facility Name
Nova Scotia Health Authority
City
Halifax
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Phillips, MD
Facility Name
Hamilton Health Sciences
City
Hamilton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelvin Ng, MD
Facility Name
Hamilton Health Sciences
City
Hamilton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Schulman, MD
Facility Name
Kingston General Hospital
City
Kingston
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirin Jalini, MD
Facility Name
London Health Science Centre - University Hospital
City
London
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Khaw, MD
Facility Name
CHUM Centre Hospitalier de l'Université de Montréal
City
Montreal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Gioia, MD
Facility Name
McGill University Health Centre
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimen Moussaddy, MD
Facility Name
The Ottawa Hospital Research Institute
City
Ottawa
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dar Dowlatshahi, MD
Facility Name
The Rhema Research Institute
City
Owen Sound
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Dafe, MD
Facility Name
CHUL Pavillon Enfant-Jésus
City
Québec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Verreault, MD
Facility Name
University of Saskatchewan
City
Saskatoon
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Graham, MD
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayman Hassan, MD
Facility Name
Sunnybrook Health Science Centre
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Gladstone, MD
Facility Name
University Health Network - Toronto Western Hospital
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Pikula, MD
Facility Name
Canadian Cardiac Research Centre
City
Windsor
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wadea Tarhuni, MD
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Du Xin, MD
Facility Name
Punan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhui Wang, MD
Facility Name
Shanghai Blue Cross Brain Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingbo Zhang, MD
Facility Name
Shanghai East Hospital, Tongji University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Li, MD
Facility Name
Shanghai Fengcheng Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Xue, MD
Facility Name
Xinhua Hospital, Chongming Branch
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen'an Wang, MD
Facility Name
Yangpu Hospital, Tongji University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhua Yue, MD
Facility Name
The First People's Hospital of Shenyang
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Li, MD
Facility Name
St. Anne's University Hospital
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Mikulik, MD
Facility Name
Neurological Department, General Hospital of Jihlava
City
Jihlava
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ondrej Skoda, MD
Facility Name
Cerebrovaskularni poradna s.r.o.
City
Ostrava
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Bar, MD
Facility Name
Alexandria University Hospital
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farouk Talaat, MD
Facility Name
Beni Suef University Hospital
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Mabrouk, MD
Facility Name
Ain Shams Specialized Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany Aref, MD
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany Aref, MD
Facility Name
Fayoum General Hospital
City
Fayoum
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa Ahmed, MD
Facility Name
Mansoura University Hospital
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamer Belal, MD
Facility Name
Tanta University Hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sayed Tag, MD
Facility Name
Zagazig University Hospital
City
Zagazig
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy Aidaros, MD
Facility Name
Charité - University Medicine Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Endres, MD
Facility Name
Dresden University Hospital "Carl Gustav Carus"
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Beyer-Westendorf, MD
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Kohrmann, MD
Facility Name
Klinikum Friedrichshafen
City
Friedrichshafen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Huber, MD
Facility Name
University Medicine Goettingen
City
Goettigen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Liman, MD
Facility Name
Martha-Maria Hospital
City
Halle
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Hoffman, MD
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goetz Thomalla, MD
Facility Name
Klinikum Main-Spessart, Krankenhaus Lohr
City
Lohr
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Kraft, MD
Facility Name
Klinik fur Neurologie, UKSH campus Lubeck
City
Lübeck
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Royl, MD
Facility Name
Medical Faculty Mannheim, Heidelberg University
City
Mannheim
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelika Alonso, MD
Facility Name
Westfalische Wilhelms-Universitat Munster
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Minnerup, MD
Facility Name
Klinikum Osnabrück; Neurologie
City
Osnabrück
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Petersen, MD
Facility Name
Department of Neurology, Klinikum Vest
City
Recklinghausen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rudiger Hilker-Roggendorf, MD
Facility Name
Universitätsklinikum Tübingen
City
Tuebingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Poli, MD
Facility Name
Zydus Hospitals & Healthcare Research Pvt. Ltd.
City
Ahmedabad
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arvind Sharma, MD
Facility Name
Shree Krishna Hospital and Pramukhswami Medical College
City
Anand
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soaham Desai, MD
Facility Name
Bangalore Baptist Hospital
City
Bangalore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumanth S., MD
Facility Name
Fortis Hospital Ltd
City
Bangalore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P R Krishnan, MD
Facility Name
Mazumdar Shaw Medical Center - Unit of Narayana Health
City
Bangalore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Huded, MD
Facility Name
St. John's Medical College Hospital
City
Bangalore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Mathew, MD
Facility Name
Post Graduate Institute of Medical Education &Research
City
Chandigarh
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dheeraj Khurana, MD
Facility Name
Sikkim Manipal Institute of Medical Sciences
City
Gangtok
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bidita Khandelwal, MD
Facility Name
GNRC Hospitals
City
Guwahati
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nomal Chandra Borah, MD
Facility Name
Bangur Institute of Neurosciences
City
Kolkata
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biman Kanti Ray, MD
Facility Name
Caritas Hospital
City
Kottayam
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Sebastian, MD
Facility Name
Christian Medical College & Hospital
City
Ludhiāna
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeyaraj D Pandian, MD
Facility Name
Dhadiwal Hospital in coalition with Shreeji Healthcare
City
Nashik
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Yeole, MD
Facility Name
Bharati Vidyapeeth (DTU) Medical College & Hospital
City
Pune
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sankar Prasad Gorthi, MD
Facility Name
Nanjappa Hospital
City
Shimoga
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D K Prashantha, MD
Facility Name
Sree Chitra Tirunal Institute for Medical Sciences and Technology
City
Thiruvananthapuram
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Padmavathy Narayanan Sylaja, MD
Facility Name
Rhythm Heart Institute
City
Vadodara
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaushik Rana, MD
Facility Name
Chitwan Everest Asptalal Private limited
City
Bharatpur
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shankar Laudari, MD
Facility Name
Chitwan Medical College Teaching Hospital
City
Bharatpur
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudhir Regmi, MD
Facility Name
Nobel Medical College & Teaching Hospital
City
Biratnagar
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prakash Kafle, MD
Facility Name
B P Koirala Institute of Health Sciences
City
Dharān Bāzār
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alok Dahal, MD
Facility Name
B & C Medical College Teaching Hospital & Research Centre Pvt. Ltd.
City
Jhapa
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karuna Tamrakar, MD
Facility Name
Annapurna Neurological institute and allied sciences
City
Kathmandu
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pravesh Rajbhandari, MD
Facility Name
Grande International Hospital
City
Kathmandu
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raju Paudel, MD
Facility Name
Kathmandu Medical College
City
Kathmandu
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Thapa, MD
Facility Name
Upendra Devkota Memorial-National Institute of Neurological and Allied Sciences (UDMNINAS)
City
Kathmandu
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lekh Jung Thapa, MD
Facility Name
CHULN-Hospital Santa Maria
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Canhão, MD
Facility Name
Coruña University Hospital
City
A Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mar Castellanos, MD
Facility Name
University Hospital of Albacete
City
Albacete
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Segura Martin, MD
Facility Name
Instituto de Investigacion Sanitaria Biocruces
City
Barakaldo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Mar Freijo, MD
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Llull Estrany, MD
Facility Name
Hospital de La Santa Creu Isant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Marti-Fabregas, MD
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Rodriguez-Campello, MD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Molina, MD
Facility Name
Complejo Hospitalario Universitario de Cáceres
City
Cáceres
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Casado-Naranjo, MD
Facility Name
Hospital Donostia - Osidonostialdea
City
Donostia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Maria De Arce Borda, MD
Facility Name
Hospital u Arnau de Vilanova de Lleida
City
Lleida
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Purroy Garcia, MD
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Gil-Núñez, MD
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Masjuan, MD
Facility Name
La Paz Univerity Hospital
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Exuperio Díez Tejedor, MD
Facility Name
Hospital Universitario Central de Asturias-Finba
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena López Cancio, MD
Facility Name
Hospital Universitario son Espases
City
Palma De Mallorca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Díaz Navarro, MD
Facility Name
Hospital Universitari i Politécnic La Fe.
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Tembl, MD
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Eckstein, MD
Facility Name
Inselspital, University Hospital Bern
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Seiffge, MD
Facility Name
Aberdeen Royal Infirmary, NHS Grampian
City
Aberdeen
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Joan Macleod, MD
Facility Name
Nevill Hall Hospital
City
Abergavenny
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bella Richard, MD
Facility Name
NHS Lanarkshire Health Board - Monklands Hospital
City
Airdrie
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Barber, MD
Facility Name
Arrowe Park Hospital
City
Birkenhead
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Menezes, MD
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamy Thavanesan, MD
Facility Name
Bradford Teaching Hospitals NHS Foundation Trust, at Bradford Royal Infirmary
City
Bradford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hawraman Ramadan, MD
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eoin OBrien, MD
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Hughes, MD
Facility Name
East Suffolk and North Essex NHS Foundation Trust, at Colchester Hospital
City
Colchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Ngeh, MD
Facility Name
Edinburgh Royal Infirmary
City
Edinburgh
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rustam Al-Shahi Salman, MD
Facility Name
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust
City
Gateshead
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Southern, MD
Facility Name
Glasgow Royal Infirmary
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Quinn, MD
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Muir, MD
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gopinath Ramadurai, MD
Facility Name
LNWUH - Northwick Park Hospital
City
Harrow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Bathula, MD
Facility Name
Calderdale and Huddersfield NHS Foundation Trust
City
Huddersfield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pratap Rana, MD
Facility Name
Victoria Hospital Kirkcaldy
City
Kirkcaldy
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Cvoro, MD
Facility Name
Homerton University Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Harrison, MD
Facility Name
King's Mill Hospital
City
Mansfield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Cooper, MD
Facility Name
The South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samer Al-Hyssayni, MD
Facility Name
Morriston Hospital
City
Morriston
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tal Anjum, MD
Facility Name
Royal Preston Hospital
City
Preston
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cosmas Anazodo, MD
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirubananthan Nagaratnam, MD
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Adie, MD
Facility Name
Hillingdon Hospital
City
Uxbridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evangelos Vasileiadis, MD
Facility Name
Southend University Hospital Southend University Hospital NHS Foundation Trust
City
Westcliff-on-Sea
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Guyler, MD
Facility Name
Yeovil District Hospital
City
Yeovil
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Rashed, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34022170
Citation
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. Erratum In: Lancet Neurol. 2021 Jun 9;:
Results Reference
derived

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EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

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