Clinical Trials Register

Summary
EudraCT Number:	2020-001817-20
Sponsor's Protocol Code Number:	NL73805.100.20
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:	2022-11-25
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-001817-20

A.3

Full title of the trial

Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation

Continuazione o interruzione periprocedurale della terapia anticogulante orale durante sostituzione valvolare aortica transcatetere

A.3.1

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

Periprocedural continuation versus interruption of blood thinners during transcatheter aortic valve implantation

Continuazione o interruzione periprocedurale della terapia anticoagulante orale in pazienti che vanno incontro a sostituzione valvolare aortica percutanea

A.3.2

Name or abbreviated title of the trial where available

POPULAR PAUSE TAVI trial

A.4.1

Sponsor's protocol code number

NL73805.100.20

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04437303

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	ST. ANTONIUS HOSPITAL
B.1.3.4	Country	Netherlands
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	St. Antonius Onderzoeksfonds
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	ZonMw
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	St. Antonius Hospital
B.5.2	Functional name of contact point	St Antonius Hospital Cardiology R&D
B.5.3	Address:
B.5.3.1	Street Address	Koekoekslaan 1
B.5.3.2	Town/ city	Nieuwegein
B.5.3.3	Post code	3435CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	3201286
B.5.6	E-mail	w.bor@antoniusziekenhuis.nl

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.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	Dabigatran
D.3.9.3	Other descriptive name	Dabigatran
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	150
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Warfarin
D.3.2	Product code	[Warfarin]
D.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	warfarin
D.3.9.3	Other descriptive name	warfarin
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	5
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: 3
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Acenocumarolo
D.3.2	Product code	[Acenocumarolo]
D.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	Acenocumarolo
D.3.9.3	Other descriptive name	Acenocumarol
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	4
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: 4
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	Edoxaban
D.3.9.3	Other descriptive name	Edoxaban
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.IMP: 5
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	Rivaroxaban
D.3.9.3	Other descriptive name	Rivaroxaban
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	20
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: 6
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Apixaban
D.3.2	Product code	[Apixaban]
D.3.4	Pharmaceutical form	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.3.9.2	Current sponsor code	Apixaban
D.3.9.3	Other descriptive name	apixaban
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	5
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

Thromboembolic, bleeding and vascular complications after transcatheter aortic valve implantation in patients using oral anticoagulants

complicanze tromboemoliche, sanguinamenti e complicanze vascolari dopo impianto percutano di protesi valvolare aortica in pazienti che assumono anticoagulanti orali

E.1.1.1

Medical condition in easily understood language

Blood clot, bleeding and vascular complications after transcatheter aortic valve implantation in patients using blood thinners

complicanze tromboemoliche, sanguinamenti e complicanze vascolari dopo impianto percutano di protesi valvolare aortica in pazienti che assumono anticoagulanti orali

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

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 evaluate the efficacy and safety of peri-procedurally continued versus interrupted oral anticoagulants in patients undergoing transcatheter aortic valve implantations

Valutare la sicurezza e l'efficacia dell'interruzione periprocedurale rispetto alla prosecuzione di anticoagulanti orali in pazienti sottoposti a TAVI, tramite la valutazione di un endpoint composito di mortalità cardiovascolare, ictus, infarto del miocardio, complicanze vascolari maggiori e complicanze emorragiche di tipo 2-4 a 30 giorni dopo TAVI come definito dai criteri VARC-3.

E.2.2

Secondary objectives of the trial

Evaluate quality of life
Evaluate cost-effectiveness

Valuta la qualità della vita
Valutare il rapporto costo-efficacia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Planned percutaneous transcatheter aortic valve implantation procedure
Uses oral anti-coagulation at screening
Written informed consent

Programma di procedura di impianto di protesi valvolare aortica percutanea transcatetere
Utilizzo di anticoagulanti orali allo screening
Consenso informato scritto

E.4

Principal exclusion criteria

Patients at high risk for thromboembolism for who interruption of oral anticoagulants is no option, i.e.:
- Mechanical heart valve
- Intracardiac thrombus
- < 3 months after venous thromboembolism
- < 6 months after TIA/stroke in patients with atrial fibrillation

Pazienti ad alto rischio di tromboembolismo per i quali l'interruzione degli anticoagulanti orali non è un'opzione, ovvero:
- Valvola cardiaca meccanica
- Trombo intracardiaco
- < 3 mesi da una tromboembolia venosa
- < 6 mesi da un TIA/ictus in pazienti con fibrillazione atriale

E.5 End points

E.5.1

Primary end point(s)

A composite of cardiovascular mortality, all stroke, myocardial
infarction, major vascular complications and type 2-4 bleeding
complications at 30 days after TAVI as defined by the VARC-3 criteria.

Endpoint composito di mortalità cardiovascolare, ictus, infarto del miocardio, complicanze vascolari maggiore e complicanze emorragiche di tipo 2-4 a 30 giorni dopo la TAVI come definito da i criteri VARC-3.

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days post procedure

30 giorni dopo la procedura di TAVI

E.5.2

Secondary end point(s)

- Procedure related primary endpoints at 30 days.
- Procedure related bleeding complications (type 1–4 bleeding ) at 30
days as defined by the VARC-3 criteria.
- Procedure related thromboembolic complications (all stroke (except
haemorrhagic), TIA, myocardial infarction, systemic embolism (vascular
complications: distal embolization (non-cerebral) from a vascular
source)) at 30 days as defined by the VARC-3 criteria.
- Thromboembolic complications (all stroke (except haemorrhagic), TIA,
myocardial infarction and systemic embolism (vascular complications:
distal embolization (non-cerebral) from a vascular source)) at discharge
and 30 days as defined by the VARC-3 criteria.
- Neurologic events (overt CNS injury, covert CNS injury, neurologic
dysfunction (acutely symptomatic) without CNS injury) at discharge and
30 days as defined by the VARC-3 criteria.
- Cerebrovascular events (all stroke, TIA) at discharge and 30 days as
defined by the VARC-3 criteria.
- All stroke at discharge and 30 days as defined by the VARC-3 criteria.
- Bleeding complications (type 1–4 bleeding) at discharge and 30 days
as defined by the VARC-3 criteria.
- Early safety at 30 days as defined by VARC-3 criteria, freedom from:
all-cause mortality, all stroke, VARC type 2–4 bleeding, major vascular,
access-related, or cardiac structural complication, acute kidney injury
stage 3 or 4, moderate or severe aortic regurgitation, new permanent
pacemaker due to procedure related conduction abnormalities, surgery
or intervention related to the device.
Clinical efficacy at 30 days as defined by VARC-3 criteria, freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve
related causes, KCCQ Overall Summary Score <45 or decline from
baseline of >10 point.
- All-cause death at discharge and 30 days.
- Cardiovascular death at discharge and 30 days.
- Quality of life (assessed by SF-12, KCCQ, and TASQ) at 30 days and 90
days.

- Componenti dell’Endpoint primario relativi alla procedura a 30 giorni.
- Complicanze emorragiche correlate alla procedura (sanguinamento di tipo 1–4) a 30 giorni come definito dai criteri VARC-3.
- Complicanze tromboemboliche correlate alla procedura (tutti gli ictus (tranne quelli emorragici), TIA, infarto del miocardio, embolia sistemica (complicazioni vascolari: embolizzazione distale (non cerebrale) da una fonte vascolare) a 30 giorni come definito dai criteri VARC-3.
- Complicanze tromboemboliche (tutti gli ictus (tranne emorragico), TIA, infarto miocardico
ed embolia sistemica (complicazioni vascolari: embolizzazione distale (non cerebrale)
da una sorgente vascolare)) alla dimissione e 30 giorni come definito dal VARC-3 criteri.
- Eventi neurologici (lesione manifesta del SNC, lesione nascosta del SNC, disfunzione neurologica (acutamente sintomatica) senza danno al SNC) alla dimissione e 30 giorni come definito dal VARC-3 criteri.
- Eventi cerebrovascolari (tutti gli ictus, TIA) alla dimissione ea 30 giorni come definiti dall'art
Criteri VARC-3.
- Tutti gli ictus alla dimissione e 30 giorni come definito dai criteri VARC-3.
- Complicanze emorragiche (emorragia di tipo 1–4) alla dimissione e a 30 giorni come definito dall'art Criteri VARC-3.
- Sicurezza precoce a 30 giorni come definito dai criteri VARC-3:
- Mortalità per tutte le cause
- Tutti gli ictus
- Sanguinamento VARC tipo 2–4
- Complicanza vascolare maggiore, correlata all'accesso, o cardiaca
- Danno renale acuto stadio 3 o 4
- Rigurgito aortico moderato o grave
- Nuovo pacemaker permanente per anomalie di conduzione correlate alla procedura
- Chirurgia o intervento relato all’impianto di protesi valvolare
Efficacia clinica a 30 giorni come definita dai criteri VARC-3:
- Mortalità per tutte le cause
- Tutti gli ictus
- Ricovero per cause relata alla procedura o alla valvola
- Punteggio generale KCCQ <45 o calo rispetto al basale di >10 punti
- Morte per tutte le cause alla dimissione e a 30 giorni.
- Morte cardiovascolare alla dimissione e a 30 giorni.
- Qualità della vita (valutata da SF-12, KCCQ e TASQ) a 30 giorni e 90 giorni.

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days post-procedure

30 giorni dopo la procedura

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

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

Yes

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

Yes

E.8.1.7.1

Other trial design description

Valutazione dell'endpoint in cieco

Blinded endpoint assessment

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Continuazione rispetto all'interruzione degli anticoagulanti orali durante la procedura

Continuation versus interruption of oral anticoagulants during procedure

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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 of 858 patients

LVLS di 858 pazienti.

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

858

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

858

F.4.2.2

In the whole clinical trial

858

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)

None

Nessuna

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

2023-03-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-04-18

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials