Clinical Trials Register

Summary
EudraCT Number:	2019-002075-33
Sponsor's Protocol Code Number:	ENRICH-AF
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-002075-33

A.3

Full title of the trial

Edoxaban for intracranial hemorrhage survivors with atrial fibrillation

EDOXABAN IN PAZIENTI CON FIBRILLAZIONE ATRIALE SOPRAVVISSUTI AD EMORRAGIA INTRACRANICA

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

Riduzione nel rischio di ictus in persone che hanno avuto sia pregressa emorragia intracranica che fibrillazione atriale

A.3.2

Name or abbreviated title of the trial where available

ENRICH-AF

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	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	0019055274322
B.5.5	Fax number	0019052973786
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	Germany
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.3.2	Product code	[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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Edoxaban
D.3.9.1	CAS number	480449-71-6
D.3.9.2	Current sponsor code	Edoxaban
D.3.9.4	EV Substance Code	SUB35059
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Germany
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.3.2	Product code	[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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Edoxaban
D.3.9.1	CAS number	480449-71-6
D.3.9.2	Current sponsor code	Edoxaban
D.3.9.4	EV Substance Code	SUB35059
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

pazienti ad alto rischio di fibrillazione atriale con pregressa emorragia intracranica.

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

Anomalia del ritmo cardiaco con rischio di formazione di coaguli di sangue e ictus in pazienti con precedente sanguinamento alla testa

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 nonanticoagulant 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.

Valutare se l’Edoxaban (60/30 mg/die), rispetto alla terapia medica senza anticoagulante (nessuna terapia antitrombotica o monoterapia antipiastrinica), riduce il rischio di ictus (composto da ictus ischemico, emorragico e non specificato) nei pazienti ad alto rischio di fibrillazione atriale (punteggio CHA2DS2-VASc =2) con pregressa emorragia intracranica.

E.2.2

Secondary objectives of the trial

i) To assess whether edoxaban (60/30 mg daily) compared to nonanticoagulant 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) Valutare se l’Edoxaban (60/30 mg/die), rispetto alla terapia medica senza anticoagulante (nessuna terapia antitrombotica o monoterapia antipiastrinica), riduce il rischio di morte cardiovascolare nei pazienti ad alto rischio di fibrillazione atriale con pregressa emorragia intracranica.

ii) Valutare se edoxaban (60/30 mg al giorno) sia associato ad un aumento del rischio di emorragia maggiore rispetto allo standard di cura (senza terapia antitrombotica o monoterapia antiaggregante piastrinica).

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

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Title: MRI Substudy (please refer to Appendix 2 of the ENRICH-AF protocol 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, diffusionweighted 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.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Titolo: MRI Substudy (please refer to Appendix 2 of the ENRICH-AF protocol for further details)
Data: 2019August19
Versione: 1.0

Il sottostudio ha lo scopo di indagare se specifici marcatori di malattie dei piccoli vasi in stadio avanzato e inclini ad emorragia (ad es. micro-sanguinamenti cerebrali e siderosi superficiale corticale) evidenziati con la Risonanza Magnetica interferiscono con l’effetto del trattamento dello studio assegnato rispetto alle ricadute di ictus e rispetto alla sicurezza dell'emorragia intracranica ricorrente. Questo sottostudio sarà effettuato in selezionati centri partecipanti a livello globale e continuerà in parallelo fino alla conclusione dello studio principale ENRICH-AF. Si stima che circa 600-800 partecipanti saranno arruolati in questo sottostudio.
Nei centri partecipanti al sottostudio MRI, sarà ottenuta una risonanza magnetica per ogni partecipante prima della randomizzazione, a meno che non esistano controindicazioni (ad esempio pacemaker, corpi estranei metallici non idonei o hardware impiantabile, claustrofobia estrema non attenuata da leggera sedazione, ecc.). Sequenze di risonanza magnetica obbligatorie sono: T2*-gradient echo o susceptibility weighted (SWI), diffusion weighted imaging (DWI), Pesatura in T1, Pesatura in T2 e FLAIR. Le risonanze magnetiche correlate allo studio devono essere ottenute previo consenso informato e prima della randomizzazione. Il T2*-gradient echo o le sequenze susceptibility weighted devono avere la priorità come sequenza iniziale durante l'acquisizione, seguite da FLAIR, Pesatura in T1, diffusion weighted imaging e Pesatura in T2

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 nonpenetrating traumatic subdural hemorrhages) on or off antithrombotic therapy (Table 2)
4. Documented atrial fibrillation (paroxysmal, persistent, permanent)
5. CHA2DS2-VASc score =2

o Consenso informato scritto.
o Età =45 anni, alla firma del consenso.
o Pregressa emorragia intracranica (sintomatica, spontanea e non traumatica intraparenchimale, intraventricolare e/o emorragia subaracnoidea della convessità (cSAH) e sintomatica spontanea o traumatica subdurale non penetrante) che si verifica in corso o meno di terapia antitrombotica;
o Fibrillazione atriale documentata (parossistica, persistente, permanente).
o Punteggio CHA2DS2-VASc =2

E.4

Principal 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)
o *Post menopausal female subjects must be amenorrheic for =12 months prior to screening or =6 weeks

o Emorragia intracranica recente (entro 14 giorni).
o Cause secondarie macrovascolari, neoplastiche o infettive (con l’eccezione del trattamento antitrombotico o emorragie subdurali traumatiche non penetranti).
o cSAH da trauma o aneurisma.
o Indicazione per terapia anticoagulante diversa dalla fibrillazione atriale (es. valvola cardiaca meccanica, malattia tromboembolica venosa).
o Indicazione per terapia antiaggregante per condizioni in cui l’Edoxaban potrebbe non essere un’alternativa adeguata.
o Previsioni di intervento chirurgico di chiusura dell’auricola.
o Valore stimato di Clearance della creatinina < 15 ml/min o in accordo al valore approvato per Edoxaban a livello locale
o Conta piastrinica < 100000/mm3 all’arruolamento o altre condizioni di diatesi emorragica.
o Ipertensione persistente e non controllata (PAS media > 150 mmHg)
o Impiego cronico di FANS
o Sanguinamento attivo clinicamente significativo, incluso sanguinamento gastrointestinale
o Lesioni o condizioni di aumentato rischio di sanguinamento clinicamente significativo (es. ulcera peptica attiva con sanguinamento recente, pazienti con alterazioni coagulative spontanee o acquisite)
o Sindrome da anticorpi anti-fosfolipidi
o Malattia epatica associata a coagulopatia e a rischio di sanguinamento clinicamente significativo
o Ipersensibilità nota ad Edoxaban
o Impossibilità, secondo giudizio dello sperimentatore, a seguire le procedure di studio
o Gravidanza e allattamento
o Aspettativa di vita, secondo giudizio dello sperimentatore, < 6 mesi al momento dell’arruolamento
o Condizioni di possibile conflitto di interessi con il centro sperimentale (es. parentela con lo sperimentatore, condizione di dipendenza lavorativa)

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

L’endpoint primario di efficacia è ictus (composito di ischemico, emorragico e non specificato)
L’endpoint primario di sicurezza è la grave emorragia come definito dai criteri della International Society on Thrombosis and Haemostasis (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).

I partecipanti saranno seguiti ogni 6 mesi fino alla data di conclusione dello studio comune. Questa sperimentazione è event-driven ed è finalizzata ad acquisire 123 eventi primari. Si prevede che ciò si verifichi un anno dopo la fine del reclutamento. La durata del follow-up per partecipante varia da 1 a 3 anni con una media di 24 mesi.

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

Gli endpoint secondari di efficacia sono:
1. Ictus ischemico
2. Morte cardiovascolare
3. Ictus emorragico
4. ictus invalidante / fatale
5. Composito di tutti gli ictus, infarto miocardico, tromboembolia sistemica o morte per tutte le cause
6. Beneficio clinico netto (composto da ictus, infarto miocardico, morte cardiovascolare, sanguinamento fatale e sanguinamento sintomatico in un organo o un'area critica)
7. Scala di Rankin modificata (mRS) a 12 mesi.

Gli end point secondari di sicurezza sono:
1. Tutte le emorragie intracraniche (emorragia intracerebrale, emorragia intraventricolare, ematoma subdurale, emorragia subaracnoidea)
2. Emorragia intracranica fatale
3. Emorragia subdurale
4. Ricovero per qualsiasi 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).

I tempi di valutazione saranno ogni 6 mesi fino alla data di fine comune dello studio. Si prevede che il follow-up sarà in media di 24 mesi per partecipante (range da 1 a 3 anni).

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

Yes

E.8.2.3.1

Comparator description

Terapia Standard o nessun trattamento

Standard therapy or no treatment

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

Information not present in EudraCT

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

Canada

Egypt

India

Nepal

Taiwan

United States

Austria

Belgium

Germany

Greece

Italy

Norway

Poland

Portugal

Slovakia

Spain

Switzerland

United Kingdom

Czechia

Argentina

E.8.7

Trial has a data monitoring committee

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

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

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.

poiché edoxaban è approvato per l'uso in questa popolazione di pazienti, i risultati di questo studio potrebbero essere implementati immediatamente dopo il completamento della sperimentazione e della sua reportistica

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

2021-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-09

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

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IMP with orphan designation in the indication
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