Clinical trial • Phase III | Phase IV • Cardiology|Neurology

Edoxaban for Atrial fibrillation | Intracranial hemorrhage

Phase III | Phase IV trial of Edoxaban for Atrial fibrillation | Intracranial hemorrhage.

Overview

Trial Therapeutic Area
Cardiology|Neurology
Trial Disease
Atrial fibrillation | Intracranial hemorrhage
Trial Stage
Phase III | Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
01-11-2024
First CTIS Authorization Date
09-12-2024

Trial design

Randomised, open-label, edoxaban 60/30 mg daily (investigational arm) versus non-anticoagulant medical therapy (comparator: either no antithrombotic therapy or antiplatelet monotherapy). no specific antiplatelet drug, dose or schedule specified for the comparator in the available data.-controlled Phase III | Phase IV trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Edoxaban 60/30 mg daily (investigational arm) versus non-anticoagulant medical therapy (comparator: either no antithrombotic therapy or antiplatelet monotherapy). No specific antiplatelet drug, dose or schedule specified for the comparator in the available data.
Target Sample Size
570
Trial Duration For Participant
365

Eligibility

Recruits 570 Vulnerable population is selected. The trial includes provisions for participants with impaired capacity: written informed consent is required from participants; country-specific informed consent forms and separate information/consent materials for adult representatives (e.g. documents titled "Patinfo Erwachsenenvertreter" and similar) and procedures for regained capacity (documents titled "wiedererlangte Einwilligungsfahigkeit" / "Patinfo wiedererlangte Einwilligungsfahigkeit") are provided. Multiple country-specific ICFs (English, French, Czech, Greek, Spanish, Portuguese, German, Slovak and others) are included, indicating local-language informed consent and use of legal/ adult representatives where applicable..

Pregnancy Exclusion
Pregnancy or breastfeeding
Vulnerable Population
Vulnerable population is selected. The trial includes provisions for participants with impaired capacity: written informed consent is required from participants; country-specific informed consent forms and separate information/consent materials for adult representatives (e.g. documents titled "Patinfo Erwachsenenvertreter" and similar) and procedures for regained capacity (documents titled "wiedererlangte Einwilligungsfahigkeit" / "Patinfo wiedererlangte Einwilligungsfahigkeit") are provided. Multiple country-specific ICFs (English, French, Czech, Greek, Spanish, Portuguese, German, Slovak and others) are included, indicating local-language informed consent and use of legal/ adult representatives where applicable.

Inclusion criteria

  • {"criterion_text":"- 1.Written informed consent provided\n- 2. Age ≥45 years, at the time of signing the informed consent\n- 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 (Table 2)\n- 4.Documented atrial fibrillation (paroxysmal, persistent, permanent)\n- 5.CHA2DS2-VASc score ≥2"}

Exclusion criteria

  • {"criterion_text":"- Recent intracranial hemorrhage (within 14 days)\n- Chronic use of NSAID\n- Clinically significant active bleeding, including gastrointestinal bleeding\n- 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\n- Antiphospholipid antibody syndrome\n- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk\n- Known hypersensitivity to edoxaban\n- Estimated inability to adhere to study procedures\n- Pregnancy or breastfeeding\n- Estimated life expectancy < 6 months at the time of enrollment\n- 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)\n- Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non- penetrating traumatic subdural hemorrhages)\n- Lobar intraparenchymal hemorrhages\n- * 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).\n- 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\n- Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)\n- Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute\n- Plans for left atrial appendage occlusion\n- Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min)\n- Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis\n- Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary efficacy end point is composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism.","definition_or_measurement_approach":"Composite of stroke (ischemic, hemorrhagic and unspecified) or systemic embolism assessed as the primary efficacy endpoint (event-driven composite)."}
  • {"endpoint_text":"- The primary safety endpoint is major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria","definition_or_measurement_approach":"Major hemorrhage will be defined and measured according to ISTH criteria."}

Secondary endpoints

  • {"endpoint_text":"- Ischemic stroke","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Cardiovascular death","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hemorrhagic stroke","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Disabling/fatal stroke","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Systemic embolism","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Composite of all stroke, myocardial infarction, systemic embolism or all cause death","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Net clinical benefit (composite of stroke, systemic embolism, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Modified Rankin scale (mRS) at 12 months","definition_or_measurement_approach":"mRS assessed at 12 months"}
  • {"endpoint_text":"- The secondary safety end point(s) are: All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Fatal intracranial hemorrhage","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Subdural hemorrhage","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hospitalization for any cause","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
570
Recruitment Window Months
68
Consent Approach
Written informed consent is required (criterion: "1.Written informed consent provided"). Country-specific subject information and informed consent forms are provided for each participating country and in multiple languages (English, French, Czech, Greek, Spanish, Portuguese, German, Slovak, etc.). Documents also include information for adult representatives and procedures for regained capacity, indicating that consent may be provided by a legal/adult representative where necessary, with subsequent consent from the participant if capacity is regained.

Geography

Total Number Of Sites
60
Total Number Of Participants
570

Austria

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
15-12-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
40

Sites

Site Name
Medical University of Vienna, Dept. of Neurology
Department Name
Neurology
Principal Investigator Name
Stefan Greisnegger
Principal Investigator Email
stefan.greisenegger@meduniwien.ac.at
Contact Person Name
Stefan Greisnegger
Site Name
Medical University of Innsbruck (Department of Neurology, Neuro-ICU)
Department Name
Neurology
Principal Investigator Name
Ronny Beer
Principal Investigator Email
ronny.beer@tirol-kliniken.at
Contact Person Name
Ronny Beer
Contact Person Email
ronny.beer@tirol-kliniken.at

Belgium

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
15
Number Of Sites
9
Number Of Participants
40

Sites

Site Name
AZ Damiaan
Department Name
Neurology
Principal Investigator Name
Adinda De Pauw
Principal Investigator Email
adepauw@azdamiaan.be
Contact Person Name
Adinda De Pauw
Contact Person Email
adepauw@azdamiaan.be
Site Name
Jessa Hospital
Department Name
Neurology
Principal Investigator Name
Nina De Klippel
Principal Investigator Email
nina.deklippel@jessazh.be
Contact Person Name
Nina De Klippel
Contact Person Email
nina.deklippel@jessazh.be
Site Name
Universitair Ziekenhuis Antwerpen (UZA)
Department Name
Neurology
Principal Investigator Name
Caroline Loos
Principal Investigator Email
caroline.loos@uza.be
Contact Person Name
Caroline Loos
Contact Person Email
caroline.loos@uza.be
Site Name
UZ Brussel
Department Name
Neurology
Principal Investigator Name
Sylvie De Raedt
Principal Investigator Email
sylvie.deraedt@uzbrussel.be
Contact Person Name
Sylvie De Raedt
Contact Person Email
sylvie.deraedt@uzbrussel.be
Site Name
Ziekenhuis Oost-Limburg
Department Name
Neurology
Principal Investigator Name
Kim Bekelaar
Principal Investigator Email
Kim.Bekelaar@zol.be
Contact Person Name
Kim Bekelaar
Contact Person Email
Kim.Bekelaar@zol.be
Site Name
Erasme Hospital
Department Name
Neurology
Principal Investigator Name
Noemie Ligot
Principal Investigator Email
noemie.ligot@erasme.ulb.ac.be
Contact Person Name
Noemie Ligot
Contact Person Email
noemie.ligot@erasme.ulb.ac.be
Site Name
Groeninge Hospital
Department Name
Neurology
Principal Investigator Name
Peter Vanacker
Principal Investigator Email
peter.vanacker@azgroeninge.be
Contact Person Name
Peter Vanacker
Contact Person Email
peter.vanacker@azgroeninge.be
Site Name
UZ Leuven
Department Name
Neurology
Principal Investigator Name
Robin Lemmens
Principal Investigator Email
robin.lemmens@uzleuven.be
Contact Person Name
Robin Lemmens
Contact Person Email
robin.lemmens@uzleuven.be
Site Name
Clinique CHC MontLégia
Department Name
Neurology
Principal Investigator Name
Philippe Desfontaines
Principal Investigator Email
philippe.desfontaines@chc.be
Contact Person Name
Philippe Desfontaines
Contact Person Email
philippe.desfontaines@chc.be

Czechia

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
15
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Cerebrovaskularni poradna s.r.o.
Department Name
Neurology
Principal Investigator Name
Michal Bar
Principal Investigator Email
michal.bar@tiscali.cz
Contact Person Name
Michal Bar
Contact Person Email
michal.bar@tiscali.cz
Site Name
Cerebrovascular outpatient clinic (Dpt. of Neurology)
Department Name
Neurology
Principal Investigator Name
Daniel Vaclavik
Principal Investigator Email
daniel.vaclavik@vtn.agel.cz
Contact Person Name
Daniel Vaclavik
Contact Person Email
daniel.vaclavik@vtn.agel.cz
Site Name
Thomayer University Hospital
Department Name
Neurology
Principal Investigator Name
David Hlinovský
Principal Investigator Email
david.hlinovsky@ftn.cz
Contact Person Name
David Hlinovský
Contact Person Email
david.hlinovsky@ftn.cz
Site Name
Neurological dept., General Hospital of Jihlava
Department Name
Neurology
Principal Investigator Name
Ondrej Skoda
Principal Investigator Email
osk@seznam.cz
Contact Person Name
Ondrej Skoda
Contact Person Email
osk@seznam.cz
Site Name
Karviná Miners Hospital Inc. (Karvinská hornická nemocnice a.s.)
Department Name
Neurology
Principal Investigator Name
Hana Palousková
Principal Investigator Email
palouskova@email.cz
Contact Person Name
Hana Palousková
Contact Person Email
palouskova@email.cz

Denmark

Earliest CTIS Part Ii Submission Date
06-12-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
4
Number Of Sites
2
Number Of Participants
32

Sites

Site Name
Bispebjerg og Frederiksberg Hospital
Department Name
Neurology
Principal Investigator Name
Hanne Christensen
Principal Investigator Email
Hanne.Krarup.Christensen@regionh.dk
Contact Person Name
Hanne Christensen
Site Name
Stroke Center Rigshospitalet
Department Name
Neurology
Principal Investigator Name
Helle Iversen
Principal Investigator Email
helle.klingenberg.iversen@regionh.dk
Contact Person Name
Helle Iversen

Greece

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
23-01-2025
Processing Time Days
58
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
Second Department of Neurology, "Attikon" University Hospital
Department Name
Neurology
Principal Investigator Name
Georgios Tsivgoulis
Principal Investigator Email
tsivgoulisgiorg@yahoo.gr
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr
Site Name
Democritus Univeristy of Thrace
Department Name
Neurology
Principal Investigator Name
Konstantinos Vadikolias
Principal Investigator Email
vadikosm@yahoo.com
Contact Person Name
Konstantinos Vadikolias
Contact Person Email
vadikosm@yahoo.com
Site Name
Ahepa University Hospital, Aristotle University of Thessaloniki
Department Name
Neurology
Principal Investigator Name
Theodoros Karapanayiotides
Principal Investigator Email
tkarapanayiotides@yahoo.gr
Contact Person Name
Theodoros Karapanayiotides
Contact Person Email
tkarapanayiotides@yahoo.gr
Site Name
University General Hospital of Patras, Department of Neurology
Department Name
Neurology
Principal Investigator Name
ioannis Ellul
Principal Investigator Email
ellul@upatras.gr
Contact Person Name
ioannis Ellul
Contact Person Email
ellul@upatras.gr

Italy

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
20
Number Of Sites
8
Number Of Participants
34

Sites

Site Name
University of I'Aquila
Department Name
Neurology
Principal Investigator Name
Simona Sacco
Principal Investigator Email
simona.sacco@univaq.it
Contact Person Name
Simona Sacco
Contact Person Email
simona.sacco@univaq.it
Site Name
Stroke Center, IRCCS Sacro Cuore Don Calabria
Department Name
Neurology
Principal Investigator Name
Alessandro Adami
Principal Investigator Email
alessandro.adami@sacrocuore.it
Contact Person Name
Alessandro Adami
Contact Person Email
alessandro.adami@sacrocuore.it
Site Name
Ospedale San Raffaele Dipartimento Neurologico - Stroke Unit
Department Name
Neurology
Principal Investigator Name
Luisa Roveri
Principal Investigator Email
roveri.luisa@hsr.it
Contact Person Name
Luisa Roveri
Contact Person Email
roveri.luisa@hsr.it
Site Name
University La Sapienza - Policlinico Umberto I
Department Name
Neurology
Principal Investigator Name
Danilo Toni
Principal Investigator Email
danilo.toni@uniroma1.it
Contact Person Name
Danilo Toni
Contact Person Email
danilo.toni@uniroma1.it
Site Name
U.O.C Neurologia / Stroke Unit
Department Name
Neurology
Principal Investigator Name
Cristina Paci
Principal Investigator Email
cristina.paci@sanita.marche.it
Contact Person Name
Cristina Paci
Contact Person Email
cristina.paci@sanita.marche.it
Site Name
IRCSS Istituto di Scienze Neurologiche di Bologna
Department Name
Neurology
Principal Investigator Name
Andrea Zini
Principal Investigator Email
a.zini@ausl.bologna.it
Contact Person Name
Andrea Zini
Contact Person Email
a.zini@ausl.bologna.it
Site Name
AOU di Modena - Stroke Unit (Clin. Neurologica - OCSAE Baggiovara-Modena)
Department Name
Neurology
Principal Investigator Name
Guido Bigliardi
Principal Investigator Email
bigliardi.guido@aou.mo.it
Contact Person Name
Guido Bigliardi
Contact Person Email
bigliardi.guido@aou.mo.it
Site Name
L'Azienda Unita Sanitaria Locale della Romagna
Department Name
Neurology
Principal Investigator Name
Michele Romoli
Principal Investigator Email
michele.romoli@auslromagna.it
Contact Person Name
Michele Romoli
Contact Person Email
michele.romoli@auslromagna.it

Portugal

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
10-12-2024
Processing Time Days
14
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
CHULN-Hospital Santa Maria
Department Name
Neurology
Principal Investigator Name
Patrica Canhao
Principal Investigator Email
pcanhao@phri.ca
Contact Person Name
Patrica Canhao
Contact Person Email
pcanhao@phri.ca
Site Name
Centro Hospitalar Universitario de Lisbona Central
Department Name
Neurology
Principal Investigator Name
Ana Paiva-Nunes
Principal Investigator Email
anapaivanunes@ulssjose.min-saude.pt
Contact Person Name
Ana Paiva-Nunes
Site Name
Centro Hospitalar de Lisoba Ocidental, E.P.E.
Department Name
Neurology
Principal Investigator Name
Miguel Viana-Baptista
Principal Investigator Email
mvianabaptista@nms.unl.pt
Contact Person Name
Miguel Viana-Baptista
Contact Person Email
mvianabaptista@nms.unl.pt
Site Name
Serviço de Neurologia, Hospital de Santo António, Centro Hospitalar do Porto
Department Name
Neurology
Principal Investigator Name
Luis Maia
Principal Investigator Email
luis.filipe.maia@chporto.min-saude.pt
Contact Person Name
Luis Maia

Slovakia

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
09-12-2024
Processing Time Days
13
Number Of Sites
2
Number Of Participants
32

Sites

Site Name
Liptov Regional Hospital
Department Name
Neurology
Principal Investigator Name
David Seiffge
Principal Investigator Email
david.seiffge@insel.ch
Contact Person Name
David Seiffge
Contact Person Email
david.seiffge@insel.ch
Site Name
University Hospital
Department Name
Neurology
Principal Investigator Name
Jens Eckstein
Principal Investigator Email
jens.eckstein@usb.ch
Contact Person Name
Jens Eckstein
Contact Person Email
jens.eckstein@usb.ch

Germany

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
15
Number Of Sites
11
Number Of Participants
80

Sites

Site Name
Innklinikum, Krankenhaus für Geriatrie & Curiositas-ad-sanum Studien
Department Name
Neurology
Principal Investigator Name
Johannes Schwarz
Principal Investigator Email
johannes.schwarz@Innklinikum.de
Contact Person Name
Johannes Schwarz
Site Name
Universitätsklinikum Tübingen
Department Name
Neurology
Principal Investigator Name
Sven Poli
Principal Investigator Email
sven.poli@uni-tuebingen.de
Contact Person Name
Sven Poli
Contact Person Email
sven.poli@uni-tuebingen.de
Site Name
Klinikum Friedrichshafen GmbH
Department Name
Neurology
Principal Investigator Name
Roman Huber
Principal Investigator Email
R.Huber@klinikum-fn.de
Contact Person Name
Roman Huber
Contact Person Email
R.Huber@klinikum-fn.de
Site Name
Department of Neurology, Medical Faculty Mannheim, Heidelberg University
Department Name
Neurology
Principal Investigator Name
Angelika Alonso
Principal Investigator Email
angelika.alonso@umm.de
Contact Person Name
Angelika Alonso
Contact Person Email
angelika.alonso@umm.de
Site Name
LMU Klinikum Institut für Schlaganfall und Demezforschung
Department Name
Neurology
Principal Investigator Name
Martin Dichgans
Principal Investigator Email
Martin.Dichgans@med.uni-muenchen.de
Contact Person Name
Martin Dichgans
Site Name
Klinikum Main-Spessart
Department Name
Neurology
Principal Investigator Name
Martin Berghoff
Principal Investigator Email
martin.berghoff@klinikum-msp.de
Contact Person Name
Martin Berghoff
Site Name
Klinik fur Neurologie, UKSH campus Lubeck
Department Name
Neurology
Principal Investigator Name
Georg Royl
Principal Investigator Email
georg.royl@neuro.uni-luebeck.de
Contact Person Name
Georg Royl
Site Name
Universitätsklinikum Hamburg-Eppendorf
Department Name
Neurology
Principal Investigator Name
Goetz Thomalla
Principal Investigator Email
thomalla@uke.de
Contact Person Name
Goetz Thomalla
Contact Person Email
thomalla@uke.de
Site Name
Charité - University Medicine Berlin
Department Name
Neurology
Principal Investigator Name
Matthias Endres
Principal Investigator Email
matthias.endres@charite.de
Contact Person Name
Matthias Endres
Contact Person Email
matthias.endres@charite.de
Site Name
Universitätsklinikum Essen
Department Name
Neurology
Principal Investigator Name
Martin Koehrmann
Principal Investigator Email
martin.koehrmann@uk-essen.de
Contact Person Name
Martin Koehrmann
Contact Person Email
martin.koehrmann@uk-essen.de
Site Name
University Medicine Goettingen
Department Name
Neurology
Principal Investigator Name
Iko Maier
Principal Investigator Email
Ilko.Maier@med.uni-goettingen.de
Contact Person Name
Iko Maier

Spain

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
12-12-2024
Processing Time Days
16
Number Of Sites
13
Number Of Participants
34

Sites

Site Name
Hospital Donostia- Osidonostialdea
Department Name
Neurology
Principal Investigator Name
Ana Maria De Arce Borda
Principal Investigator Email
anamaria.dearceborda@osakidetza.eus
Contact Person Name
Ana Maria De Arce Borda
Site Name
Hospital Universitari Joan XXIII
Department Name
Neurology
Principal Investigator Name
Laia Sero Ballesteros
Principal Investigator Email
lsero.hj23.ics@gencat.cat
Contact Person Name
Laia Sero Ballesteros
Contact Person Email
lsero.hj23.ics@gencat.cat
Site Name
University Hospital of Albacete
Department Name
Neurology
Principal Investigator Name
Tomas Segura Martin
Principal Investigator Email
tseguram@gmail.com
Contact Person Name
Tomas Segura Martin
Contact Person Email
tseguram@gmail.com
Site Name
Hospital Universitari Vall d’Hebron
Department Name
Neurology
Principal Investigator Name
Carlos Molina
Principal Investigator Email
cmolina@vhebron.net
Contact Person Name
Carlos Molina
Contact Person Email
cmolina@vhebron.net
Site Name
CORUÑA UNIVERSITY HOSPITAL
Department Name
Neurology
Principal Investigator Name
Maria Castellanos
Contact Person Name
Maria Castellanos
Site Name
LA PAZ UNIVERITY HOSPITAL
Department Name
Neurology
Principal Investigator Name
Exuperio Díez Tejedor
Principal Investigator Email
exuperio.diez@salud.madrid.org
Contact Person Name
Exuperio Díez Tejedor
Contact Person Email
exuperio.diez@salud.madrid.org
Site Name
Hospital Universitari i Politécnic La Fe.
Department Name
Neurology
Principal Investigator Name
Jose Tembl
Principal Investigator Email
jtembl@gmail.com
Contact Person Name
Jose Tembl
Contact Person Email
jtembl@gmail.com
Site Name
Hospital Del Mar
Department Name
Neurology
Principal Investigator Name
Ana Rodriguez-Campello
Principal Investigator Email
Arodriguezc@parcdesalutmar.cat
Contact Person Name
Ana Rodriguez-Campello
Contact Person Email
Arodriguezc@parcdesalutmar.cat
Site Name
COMPLEJO HOSPITALARIO UNIVERSITARIO DE CÁCERES
Department Name
Neurology
Principal Investigator Name
Ignacio Casado Naranjo
Principal Investigator Email
icasadon@gmail.com
Contact Person Name
Ignacio Casado Naranjo
Contact Person Email
icasadon@gmail.com
Site Name
Hospital General Universitario Gregorio Marañon
Department Name
Neurology
Principal Investigator Name
Antonio Gil-Núñez
Principal Investigator Email
gilnuneza@gmail.com
Contact Person Name
Antonio Gil-Núñez
Contact Person Email
gilnuneza@gmail.com
Site Name
HOSPITAL CLINICO UNIVERSITARIO VIRGEN DE LA ARRIXACA
Department Name
Neurology
Principal Investigator Name
Ana Morales Ortiz
Principal Investigator Email
amoralesortiz@gmail.com
Contact Person Name
Ana Morales Ortiz
Contact Person Email
amoralesortiz@gmail.com
Site Name
Hospital Ramón y Cajal
Department Name
Neurology
Principal Investigator Name
Jaime Masjuan
Principal Investigator Email
jaime.masjuan@gmail.com
Contact Person Name
Jaime Masjuan
Contact Person Email
jaime.masjuan@gmail.com
Site Name
Hospital Clínic Barcelona
Department Name
Neurology
Principal Investigator Name
Laura Llull Estrany
Principal Investigator Email
blllull@clinic.cat
Contact Person Name
Laura Llull Estrany
Contact Person Email
blllull@clinic.cat

Sponsor

Primary sponsor

Full Name
Hamilton Health Sciences Corporation
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Canada

Contract research organisations

Name
PHAZE Clinical Research & Pharma Consulting S.A
Responsibilities
[{"id":989676,"code":"12"},{"id":989677,"code":"5"}]

Third parties

  • {"country":"Greece","full_name":"PHAZE Clinical Research & Pharma Consulting S.A","duties_or_roles":"[{\"id\":989676,\"code\":\"12\"},{\"id\":989677,\"code\":\"5\"}]","organisation_type":"Health care"}
  • {"country":"Denmark","full_name":"Bispebjerg Hospital","duties_or_roles":"[{\"id\":989678,\"code\":\"1\"}]","organisation_type":"Health care"}

Co-sponsors

  • PHRI Population Health Research Institute International

Investigational products

Investigational Product Name
Lixiana 60 mg film-coated tablets
Active Substance
Edoxaban
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/15/993/024)
Starting Dose
60 mg daily
Dose Levels
60 mg (also available 30 mg formulation)
Frequency
Daily
Maximum Dose
60 mg
Investigational Product Name
Lixiana 30 mg film-coated tablets
Active Substance
Edoxaban
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/15/993/011)
Starting Dose
30 mg daily
Dose Levels
30 mg (also available 60 mg formulation)
Frequency
Daily
Maximum Dose
30 mg

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