Clinical Trials Register

Summary
EudraCT Number:	2019-002075-33
Sponsor's Protocol Code Number:	ENRICH-AF
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-01-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-002075-33

A.3

Full title of the trial

Edoxaban for intracranial hemorrhage survivors with atrial fibrillation

Edoxabán para supervivientes de hemorragia intracraneal con fibrilación auricular

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Reduction in the risk of stroke in people who have both a previous intracranial bleed and atrial fibrillation

Reducción del riesgo de apoplejía en personas que tienen hemorragia intracraneal previa y fibrilación auricular

A.3.2

Name or abbreviated title of the trial where available

ENRICH-AF: EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation

A.4.1

Sponsor's protocol code number

ENRICH-AF

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03950076

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Hamilton Health Sciences, through its Population Health Research Institute
B.1.3.4	Country	Canada
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Daiichi Sankyo
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hamilton Health Sciences, through its Population Health Research Institute
B.5.2	Functional name of contact point	ENRICH-AF Research Coordinator
B.5.3	Address:
B.5.3.1	Street Address	237 Barton Street East
B.5.3.2	Town/ city	Hamilton
B.5.3.3	Post code	L8L 2X2
B.5.3.4	Country	Canada
B.5.4	Telephone number	1905527-4322
B.5.5	Fax number	1905297-3786
B.5.6	E-mail	ENRICH-AF@phri.ca

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Lixiana
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sankyo Europe GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Edoxaban
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Lixiana
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sankyo Europe GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Edoxaban
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

High risk atrial fibrillation patients with previous intracranial hemorrhage

Pacientes de alto riesgo de fibrilación auricular con hemorragia intracraneal previa

E.1.1.1

Medical condition in easily understood language

Abnormal heart rhythm with a risk of blood clot formation and stroke in patients with previous bleeding in the head.

Ritmo cardíaco anormal con riesgo de formación de coágulos sanguíneos y accidente cerebrovascular en pacientes con sangrado previo en la cabeza.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10018985
E.1.2	Term	Haemorrhage intracranial
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10003658
E.1.2	Term	Atrial fibrillation
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine whether edoxaban (60/30 mg daily) compared to non-anticoagulant 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 score ≥2) patients with previous intracranial hemorrhage.

Determinar si edoxaban (60/30 mg al día) en comparación con el tratamiento médico no anticoagulante (sin terapia antitrombótica o monoterapia antiplaquetaria) reduce el riesgo de accidente cerebrovascular (compuesto de accidente cerebrovascular isquémico, hemorrágico y no especificado) en pacientes con fibrilación auricular de alto riesgo (puntuación CHA2DS2-Vasc 2) con hemorragia intracraneal previa.

E.2.2

Secondary objectives of the trial

i) To assess whether edoxaban (60/30 mg daily) compared to non-anticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of cardiovascular death in high-risk atrial fibrillation participants with previous intracranial hemorrhage.

ii) To assess whether edoxaban (60/30 mg daily) is associated with increased risk of major hemorrhage compared to standard of care (either no antithrombotic therapy or antiplatelet monotherapy).

i) Para evaluar si edoxaban (60/30 mg al día) en comparación con el tratamiento médico no anticoagulante (sin terapia antitrombótica o monoterapia antiplaquetaria) reduce el riesgo de muerte cardiovascular en pacientes deriesgo de fibrilación auricular participantes con hemorragia intracraneal previa.

ii) Evaluar si edoxaban (60/30 mg diarios) está asociado con un mayor riesgo de hemorragia grave en comparación con la atención estándar (o bien no hay terapia antitrombótica o monoterapia antiplaquetaria).

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Title: MRI Substudy (please refer to Appendix 2 of the ENRICH-AF protocol (global) for further details)
Date: 2019August19
Version: 1.0

The substudy aims to investigate the potential for treatment effect modification with baseline MRI markers of advanced cerebral small vessel disease, including cerebral microbleeds and cortical superficial siderosis, for the primary outcome of stroke and safety outcome of recurrent intracranial hemorrhage. This substudy will be launched at select global participating centers by the end of 1st quarter of 2020 and will continue in unison until study termination of the broader ENRICH-AF trial. An estimated 600-800 participants will be enrolled in this substudy.

An MRI will be obtained for each participant before randomization, unless contraindications exist (i.e. pacemakers, ineligible metallic foreign bodies or implantable hardware, extreme claustrophobia unmitigated by light sedation, etc.). Mandated MRI sequences including T2*-gradient echo or susceptibility weighted sequences, diffusion-weighted imaging, T1-weighted, T2-weighted, and FLAIR. Study-related MRIs must be obtained following informed consent and prior to randomization. T2*-gradient echo or susceptibility weighted sequences should be prioritized as the initial sequence during acquisition, followed by FLAIR, T1-weighted, diffusion-weighted imaging and T2-weighted sequences.

Título: Subestudio de resonancia magnética (consulte el Apéndice 2 del protocolo ENRICH-AF (global) para obtener más detalles)
Fecha: 2019 agosto19
Versión: 1.0

El subestudio tiene como objetivo investigar el potencial de modificación del efecto del tratamiento con marcadores basales de resonancia magnética de la enfermedad cerebral avanzada de los vasos pequeños, incluidas las micro hemorragias cerebrales y la siderosis superficial cortical, para el resultado primario del accidente cerebrovascular y el resultado de seguridad de la hemorragia intracraneal recurrente. Este subestudio se lanzará en centros selectos de participantes mundiales a fines del primer trimestre de 2020 y continuará al unísono hasta la finalización del estudio del ensayo ENRICH-AF más amplio. Se estima que entre 600 y 800 participantes se inscribirán en este subestudio.

Se obtendrá una resonancia magnética para cada participante antes de la aleatorización, a menos que existan contraindicaciones (es decir, marcapasos, cuerpos extraños metálicos no elegibles o hardware implantable, claustrofobia extrema no mitigada por sedación ligera, etc.).

Las imágenes relacionadas con el estudio deben obtenerse luego del consentimiento informado y antes de la aleatorización.

E.3

Principal 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 (Table 2)
4. Documented atrial fibrillation (paroxysmal, persistent, permanent)
5. CHA2DS2-VASc score ≥2

1. Consentimiento informado por escrito proporcionado
2. Edad ≥45 años, en el momento de la firma del consentimiento informado
3. Hemorragia intracraneal previa (intraparenquimatosa, intraventricular y/o HSAc sintomática, espontánea y no traumática y hemorragias subdurales sintomáticas espontáneas o traumáticas no penetrantes) con o sin tratamiento antitrombótico (Tabla 2)
4. Fibrilación auricular documentada (paroxística, persistente, permanente)
5. Puntuación CHA2DS2-VASc ≥2

E.4

Principal exclusion criteria

1. Recent intracraneal 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).

1. Hemorragia intracraneal reciente (en los últimos 14 días)
2. Causas secundarias macrovasculares, neoplásicas o infecciosas de hemorragia endocraneal (excepto para tratamiento antitrombótico o hemorragias subdurales traumáticas no penetrantes)
3. HSAc traumática o aneurismática
4. Necesidad de un tratamiento anticoagulante oral continuo para otra indicación distinta de la FA (p. ej., válvula cardíaca mecánica, enfermedad tromboembólica venosa)
5. Necesidad de un tratamiento antiplaquetario continuo para otra indicación en la que edoxabán no sea un sustituto adecuado
6. Planes de oclusión del apéndice auricular izquierdo
7. Aclaramiento de creatinina (ACr) estimado < 15 mL/min u otro aclaramiento de creatinina según la monografía local del producto (Canadá < 30 mL/min)
8. Numero de trombocitos inferior a 100 000 mm3 en el momento del reclutamiento u otra diátesis hemorrágica
9. Hipertensión persistente no controlada (PA sistólica promedio > 150 mmHg)
10. Uso crónico de AINE
11. Hemorragia activa clínicamente significativa, incluida la hemorragia gastrointestinal
12. Lesiones o enfermedades con un mayor riesgo de hemorragia clínicamente significativa, como p. ej., úlcera péptica activa con hemorragia reciente, pacientes con alteración de la hemostasia espontánea o adquirida.
13. Síndrome del anticuerpo antifosfolipídico
14. Enfermedad hepática asociada con coagulopatía y riesgo de hemorragia clínicamente significativo
15. Hipersensibilidad conocida a edoxabán
16. Incapacidad prevista para observar los procedimientos del estudio
17. Embarazo o lactancia
18. Esperanza de vida estimada < 6 meses en el momento del reclutamiento
19. Vinculación estrecha con el centro de investigación, p. ej., un familiar cercano al investigador, una persona dependiente (p. ej., empleado o estudiante del centro de investigación)

* Los sujetos mujeres posmenopáusicas deben presentar amenorrea durante ≥12 meses antes de la selección o ≥6 semanas tras una ovariectomía bilateral posquirúrgica (con o sin histerectomía) antes de la selección. Las mujeres en edad fértil deben presentar una prueba de embarazo de suero negativa dentro de los 7 días anteriores a la aleatorización o una prueba de embarazo de orina dentro de las 24 horas anteriores a la aleatorización. Las mujeres heterosexualmente activas en edad fértil deben utilizar métodos anticonceptivos altamente eficaces durante 32 días tras la interrupción (duración del fármaco del estudio más la duración de 30 días de un ciclo ovulatorio).

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy end point is stroke (composite of ischemic, hemorrhagic and unspecified).

The primary safety endpoint is major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria

El principal punto final de eficacia es el accidente cerebrovascular (compuesto de isquémico, hemorrágico y no especificado).

El criterio principal de valoración de la seguridad es la hemorragia grave, tal como se define en los criterios de la Sociedad Internacional de Trombosis y Hemostasia (ISTH)

E.5.1.1

Timepoint(s) of evaluation of this end point

Participants will be followed every 6 months until the common study end date. This trial is event driven to accrue 123 primary events, anticipated one year after the end of the recruitment. Follow up is anticipated to be an average of 24 months per participant (range 1 to 3 years).

Los participantes serán seguidos cada 6 meses hasta la fecha final del estudio común. Este juicio está dirigido a la acumulación de 123 eventos principales, previstos un año después de la finalización de la contratación. Se prevé que el seguimiento sea de una media de 24 meses por participante (intervalo de 1 a 3 años).

E.5.2

Secondary end point(s)

The secondary efficacy end points are:
1. Ischemic stroke
2. Cardiovascular death
3. Hemorrhagic stroke
4. Disabling/fatal stroke
5. Composite of all stroke, myocardial infarction, systemic thromboembolism or all-cause death
6. Net clinical benefit (composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area)
7. Modified Rankin scale (mRS) at 12 months

The secondary safety end point(s) are:
1. All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage)
2. Fatal intracranial hemorrhage
3. Subdural hemorrhage
4. Hospitalization for any cause

Los puntos finales secundarios de eficacia son:
Ictus isquémico
• Muerte cardiovascular
• Ictus hemorrágico
• Ictus discapacitante/mortal
• Compuesto por todos los ictus, infarto de miocardio, tromboembolia sistémica o mortalidad general
• Beneficio clínico neto (compuesto por ictus, infarto de miocardio, muerte cardiovascular, hemorragia mortal y hemorragia sintomática en un órgano o zona crítica)
• Escala de Rankin modificada (ERm) a 12 meses

Los puntos finales de seguridad secundarios son:
Todas las hemorragias endocraneales (hemorragia cerebral, hemorragia intraventricular, hematoma subdural, hemorragia subaracnoidea)
• Hemorragia endocraneal mortal
• Hemorragia subdural
• Hospitalización por cualquier causa

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoints of evaluation will be every 6 months until the common study end date. Follow up is anticipated to be an average of 24 months per participant (range 1 to 3 years).

Los plazos de evaluación serán cada 6 meses hasta la fecha final del estudio común. Se prevé que el seguimiento sea de una media de 24 meses por participante (intervalo de 1 a 3 años).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

159

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Austria

Belgium

Canada

Chile

China

Czech Republic

Egypt

Germany

Greece

India

Italy

Korea, Republic of

Nepal

Norway

Poland

Portugal

Spain

Sweden

Switzerland

Taiwan

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Última visita, Último sujeto

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

240

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

960

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

125

F.4.2

For a multinational trial

F.4.2.1

In the EEA

720

F.4.2.2

In the whole clinical trial

1200

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

As edoxaban is approved for use in this patient population, results of this study could be implemented immediately upon completion/reporting of the trial.

Dado que se ha aprobado el uso de edoxaban en esta población de pacientes, los resultados de este estudio podrían aplicarse inmediatamente después de la finalización/notificación del ensayo.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-03-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-26

P. End of Trial
P.	End of Trial Status	Ongoing

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Clinical trials