Clinical Trials Register

Summary
EudraCT Number:	2013-001657-28
Sponsor's Protocol Code Number:	CTHC002
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-05
Trial results	View 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

2013-001657-28

A.3

Full title of the trial

Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban: Prospective Management Trial (HoT-PE)

Trattamento domiciliare dei pazienti con embolia polmonare a basso rischio con l¿inibitore del fattore Xa orale rivaroxaban: studio prospettico di gestione (Hot-PE)

A.3.1

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

Home Treatment of Patients with Low-Risk Pulmonary Embolism with Rivaroxaban

Trattamento domiciliare dei pazienti con embolia polmonare a basso rischio con rivaroxaban

A.3.2

Name or abbreviated title of the trial where available

HoT-PE

A.4.1

Sponsor's protocol code number

CTHC002

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	UNIVERSITY MEDICAL SCHOOL OF THE JOHANNES GUTENBERG UNIVERSITY MAINZ
B.1.3.4	Country	Germany
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	BAYER PHARMA AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Medical Center of the Johannes Gutenberg University Mainz
B.5.2	Functional name of contact point	Porf. Dr. S. Konstantinides
B.5.3	Address:
B.5.3.1	Street Address	Langenbeckstr. 1
B.5.3.2	Town/ city	Mainz
B.5.3.3	Post code	D-55131
B.5.3.4	Country	Germany
B.5.4	Telephone number	00496131178382
B.5.5	Fax number	00496131178461
B.5.6	E-mail	stavros.konstantidines@unimedizin-mainz.de

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	XARELTO - 15 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER PHARMA AG
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	Xarelto 15 mg compresse rivestite con film
D.3.2	Product code	[Xarelto 15 mg compresse rivestite con film]
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	RIVAROXABAN
D.3.9.1	CAS number	366789-02-8
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB29263
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	15
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	XARELTO - 20 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER PHARMA AG
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	Xarelto 20 mg
D.3.2	Product code	[Xarelto 20mg]
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	RIVAROXABAN
D.3.9.1	CAS number	366789-02-8
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB29263
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.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

Acute low-risk pulmonary embolism (PE)

Embolia polmonare acuta (EP) a basso rischio

E.1.1.1

Medical condition in easily understood language

Acute low-risk pulmonary embolism (PE)

Embolia polmonare acuta (EP) a basso rischio

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	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10037379
E.1.2	Term	Pulmonary embolism and thrombosis
E.1.2	System Organ Class	100000004866

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 early discharge and out-of-hospital treatment of patients with low-risk acute PE (as defined by the inclusion and exclusion criteria) with the new oral factor Xa inhibitor rivaroxaban is feasible, effective, and safe.

Stabilire se la dimissione precoce e il trattamento al di fuori dell¿ambito ospedaliero dei pazienti con EP acuta a basso rischio (secondo quanto definito dai criteri di inclusione ed esclusione) con il nuovo inibitore del fattore Xa orale rivaroxaban siano realizzabili, efficaci e sicuri.

E.2.2

Secondary objectives of the trial

-To determine whether early discharge and out-of-hospital treatment of low-risk acute PE with the new oral factor Xa inhibitor rivaroxaban can result in good quality of life and patient satisfaction
-To obtain valid health economic variables as a basis for description of resource utilization, including validation of a disease-specific quality of life questionnaire, and of existing Markov models.

- Stabilire se la dimissione precoce e il trattamento al di fuori dell¿ambito ospedaliero dei pazienti con EP acuta a basso rischio con il nuovo inibitore del fattore Xa orale rivaroxaban possa determinare una buona qualità di vita e la soddisfazione dei pazienti
- Ottenere valide variabili economiche sanitarie da usare come base per la descrizione dell¿utilizzo delle risorse, inclusa la validazione di un questionario sulla qualità di vita specifico per la malattia e dei modelli di Markov esistenti.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Age =18 years;
2) Ability of subject to understand character and individual consequences of clinical trial;
3) Signed and dated informed consent of the subject available before the start of any specific trial procedures;
4) Women of childbearing potential have to practice a medically accepted contraception (non-hormonal intrauterine device, two independent barriers, female or male surgical sterilization, or two years postmeno-pausal) during the trial, and a negative pregnancy test (serum or urine) should be available before inclusion in the trial;
5) Objectively confirmed diagnosis of acute PE by multidetector computed tomographic (CT) pulmonary angiography, pulmonary angiography, or V/Q lung scan according to established diagnostic criteria, with or without symptomatic deep vein thrombosis;
6) Absence of right ventricular (RV) enlargement or dysfunction, and of free floating thrombi in the right atrium or right ventricle on echocardiography or computed tomography.
On echocardiography, RV enlargement/dysfunction is absent when both criteria listed
below are met:
- Right/left ventricular end-diastolic diameter ratio < 0.9 (apical or subcostal 4-chamber
view)
- No paradoxical motion of the interventricular septum
On CT angiography, RV enlargement/dysfunction is absent when the following criterion is
met:
- Right/left short-axis diameter ratio < 0.9 (transverse plane)

1) Età =18 anni
2) Capacità del soggetto di comprendere le caratteristiche e le conseguenze individuali dello studio clinico
3) Consenso informato firmato e datato da parte del soggetto, disponibile prima dell’inizio di qualsiasi procedura specifica dello studio
4) Le donne in età fertile devono adottare un metodo di contraccezione medicalmente accettato (dispositivo intrauterino non ormonale, due metodi di barriera diversi, sterilizzazione chirurgica femminile o maschile o due anni di post-menopausa) nel corso dello studio e deve essere disponibile un test di gravidanza con esito negativo (su siero o urine) prima dell’inclusione nello studio
5) Diagnosi confermata obiettivamente di EP acuta valutata tramite angiografia polmonare con tomografia computerizzata (TC) multidetettore, angiografia polmonare o scintigrafia polmonare V/Q, in base ai criteri diagnostici stabiliti, con o senza trombosi venosa profonda sintomatica
6) Assenza di dilatazione o disfunzione ventricolare destra (VD) e di trombi liberi nell’atrio destro o nel ventricolo destro all’ecocardiografia o alla tomografia computerizzata.
All’ecocardiografia, la dilatazione/disfunzione VD è assente quando sono soddisfatti entrambi i criteri sotto elencati:
- Rapporto diametro ventricolare telediastolico destro/sinistro <0,9 (proiezione apicale o sottocostale 4 camere)
- Assenza di movimento paradosso nel setto interventricolare
All’angiografia TC, la dilatazione/disfunzione VD è assente quando è soddisfatto il seguente criterio:
- Rapporto diametro dell’asse corto destro/sinistro <0,9 (piano trasversale)

E.4

Principal exclusion criteria

1) Pregnancy or lactation;
2) Historyof hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product;
3) Participation in other clinical trials during the present clinical trial or within the last 6 months;
4) Medical or psychological condition that would not permit completion of the trial or signing of informed consent;
5) Hemodynamic instability at presentation, indicated by at least one of the following; (i) systolic boold pressure (SBP) < 100 mm Hg, or heart rate > 100 beats per minute, or SBP drop by >40 mm Hg, for >15 min; (ii) need for catecholamines to maintain adequate organ perfusion amd a systolic blood pressure of > 100 mm Hg; (iiiù9 need for cardiopulmonary resuscitation;
7) Chronic treatment with a vitamin K antagonist, rivaroxaban or any other ora or parental anticoagulant drug;
8) Use of a fibrinolytic agent, surgical thromectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE;
9) Need for supplemental oxygen asministration to maintain oxygen saturation > 90%;
10) Pain requiring parenteral administration of analgesic agents;
11) Other medical conditions/comorbidities requiring hospitalization;
12) Acute PE diagnosed in a patient already hospitalized for another condition;
13) Active bleeding or known significant bleeding risk;
14) Severe renal insufficiency (estimated GFR < 15 ml/min/1.73m2 by the MDRD formula) or end-stage renal disease;
15) Severe hepatic failure;
16) Concomitant administration of strong inhibitors of P-gp and CYP3A4 such as azole antimycotic agents or HIV protease inhibitors;
17) Need for long-term treatment vitamin K antagonist, or for antiplatelet agents except acetylsalicylic acid at a dosage =100 mg/day;
18) Non-compliance or inability to adhere to treatment or to the follow-up visits; or lack of a family enviroment or support system for home treatment;
19) life expectancy less than 3 months

1) Gravidanza o allattamento
2) Anamnesi di ipersensibilità al prodotto medicinale sperimentale o a qualsiasi farmaco con struttura chimica simile o a qualsiasi eccipiente presente nella forma farmaceutica del prodotto medicinale sperimentale
3) Partecipazione ad altri studi clinici durante lo svolgimento del presente studio o negli ultimi sei mesi
4) Condizione medica o psicologica che non permetta il completamento dello studio o la firma del consenso informato
5) Instabilità emodinamica alla presentazione, indicata dalla presenza di almeno una delle seguenti condizioni: (i) pressione arteriosa sistolica (SBP) <100 mmHg, o frequenza cardiaca >100 battiti al minuto o caduta della SBP di >40 mmHg per >15 min; (ii) necessità di assumere catecolamine per mantenere un’adeguata perfusione d’organo e una pressione arteriosa sistolica >100 mmHg; (iii) necessità di rianimazione cardiopolmonare
6) Trattamento dell’episodio acuto (indice) con eparina non frazionata, eparina a basso peso molecolare, fondaparinux o un nuovo anticoagulante orale per più di 48 ore o con più di una dose singola di un antagonista della vitamina K prima dell’inclusione nello studio
7) Trattamento cronico con un antagonista della vitamina K, rivaroxaban o qualsiasi altro farmaco anticoagulante assunto per via orale o parenterale
8) Ricorso a un agente fibrinolitico, trombectomia chirurgica, procedura interventistica (transcatetere) di aspirazione o di lisi del trombo, oppure uso di un filtro della vena cava per il trattamento dell’episodio indice di EP
9) Necessità di somministrazione supplementare di ossigeno per mantenere una saturazione dell’ossigeno >90%
10) Dolore che richieda la somministrazione di analgesici per via parenterale
11) Altre condizioni mediche/comorbilità che richiedano il ricovero
12) EP acuta diagnosticata in un paziente già ricoverato per un’altra condizione
13) Emorragia in atto o rischio noto di emorragie significative
14) Insufficienza renale grave (GFR stimata <15 mL/min/1,73m2 secondo la formula MDRD) o nefropatia allo stadio terminale
15) Insufficienza epatica grave
16) Somministrazione concomitante di forti inibitori di P-gp e CYP3A4 come gli agenti antimicotici azolici o gli inibitori delle proteasi dell’HIV
17) Necessità di trattamento a lungo termine con antagonisti della vitamina K o di agenti antipiastrinici eccetto l’acido acetilsalicilico a un dosaggio ¿100 mg/die
18) Mancata compliance o incapacità di adesione al trattamento o alle visite di follow-up o mancanza di un contesto familiare o di un sistema di supporto per il trattamento domiciliare
19) Aspettativa di vita inferiore a 3 mesi

E.5 End points

E.5.1

Primary end point(s)

Symptomatic recurrent venous thromboembolism (VTE) or death related to pulmonary embolism

Tromboembolia venosa (VTE) sintomatica ricorrente o decesso correlato a embolia polmonare entro 3 mesi dall’arruolamento.

E.5.1.1

Timepoint(s) of evaluation of this end point

within 3 months from the enrolment

entro 3 mesi dall'arruolamento

E.5.2

Secondary end point(s)

1) All-cause mortality within 7 days;
2) All.cause mortality within 3 weeks;
3) All.cause mortality within 3 months;
4) Overall duration of hospital stay (index event and repeated hospitalizations due to PE [index or recurrent avent] or to a bleeding event) within 3 months;
5) Rehospitalization due to PE (index or recurrent event) or to a bleeding event within 3 months;
6) Generic and disease.specific qulaity of life at baseline, 1 week, 3 weeks and 3 months;
7) Treatment satisfaction at 3 weeks and 3 months;
8) Utilization of health care resources at 3 weeks and 3months;
9) All-cause mortality at one year.
Safety outcomes:
1) Major bleeding, based on the ISTH definition, within 7 days, 3 weeks, and 3 months;
2) Clinically relevant bleeding, defined as a composite of major or clinically relevant non-major bleeding, within 7 days, 3 weeks and 3 months;
3) Serious adverse events (SAE) within 7 days, 3 weeks and 3 months.

1) Mortalit¿ per tutte le cause entro 7 giorni
2) Mortalit¿ per tutte le cause entro 3 settimane
3) Mortalit¿ per tutte le cause entro 3 mesi
4) Durata complessiva della degenza in ospedale (evento indice e ricoveri ripetuti per EP [evento indice o ricorrente] o per un evento emorragico) entro 3 mesi
5) Nuovo ricovero per EP (evento indice o ricorrente) o per un evento emorragico entro 3 mesi
6) Qualit¿ di vita generica e in relazione alla malattia specifica al basale, a 1 settimana, a 3 settimane e a 3 mesi
7) Soddisfazione in merito al trattamento a 3 settimane e a 3 mesi
8) Utilizzo di risorse sanitarie a 3 settimane e a 3 mesi
9) Mortalit¿ per tutte le cause a un anno. Outcome di sicurezza:
1) Emorragia maggiore, secondo la classificazione ISTH, entro 7 giorni, 3 settimane e 3 mesi
2) Emorragia clinicamente rilevante, definita dalla presenza di sanguinamento maggiore o non maggiore clinicamente rilevante, entro 7 giorni, 3 settimane e 3 mesi
3) Eventi avversi (EA) gravi entro 7 giorni, 3 settimane e 3 mesi

E.5.2.1

Timepoint(s) of evaluation of this end point

7 days, 3 weeks and 3 months

7 giorni, 3 settimane e 3 mesi

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

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

E.8.1.1

Randomised

E.8.1.2

Open

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)

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

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

last visit last subject

ultima visita ultimo soggetto

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:

800

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1100

F.4.2.2

In the whole clinical trial

1100

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)

Rivaroxaban as study medication will be taken for a period of 3 months. After that period continuation of anticoagulation and the anticoagulant drug to be used will be at the discretion of the patient¿s physician.

Rivaroxaban verrà assunto per un periodo di 3 mesi. Alla fine di tale periodo la continuazione della terapia anticoagulante e il farmaco anticoagulante da utilizzare saranno a discrezione del medico del paziente.

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

2016-07-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-16

P. End of Trial
P.	End of Trial Status	Completed

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Clinical trials