Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39361   clinical trials with a EudraCT protocol, of which   6446   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-002176-41
    Sponsor's Protocol Code Number:17HH4268
    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:2019-04-12
    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.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-002176-41
    A.3Full title of the trial
    PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF)
    Prevención del ICTUS en supervivientes de hemorragia intracerebral con fibrilación auricular (PRESTIGE-AF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of Stroke in Survivors of Brain Bleeding with Atrial Fibrillation
    Prevención de ICTUS en supervivientes de hemorragia cerebral con fibrilación auricular
    A.3.2Name or abbreviated title of the trial where available
    PRESTIGE-AF
    PRESTIGE-AF
    A.4.1Sponsor's protocol code number17HH4268
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImperial College of Science, Technology and Medicine
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Union
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College of Science, Technology and Medicine
    B.5.2Functional name of contact pointGisela Pereira Barreto
    B.5.3 Address:
    B.5.3.1Street AddressJoint Research Compliance Office, Room 221, Level 2
    B.5.3.2Town/ cityMedical School Building, Norfolk Place, London
    B.5.3.3Post codeW2 1PG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02075949480
    B.5.6E-mailg.pereira-barreto@imperial.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Eliquis
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb / Pfizer EEIG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEliquis
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPIXABAN
    D.3.9.3Other descriptive nameApixaban
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 5.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Pradaxa
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePradaxa
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDABIGATRAN ETEXILATE
    D.3.9.1CAS number 211915-06-9
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number110 to 150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lixiana
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo , Inc.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLixiana
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEdoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.3Other descriptive nameEDOXABAN
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXarelto
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Ischaemic stroke prevention in patients with atrial fibrillation and previous intracerebral haemorrhage
    Prevención del ictus isquémico en pacientes con fibrilación auricular y hemorragia intracerebral previa
    E.1.1.1Medical condition in easily understood language
    Prevention of stroke (caused by a blood clot) in patients with a heart arrhythmia (atrial fibrillation) who have had a
    previous brain bleed (intracerebral haemorrhage)
    Prevención del accidente cerebrovascular (debido a un coágulo de sangre) en pacientes con arritmia cardíaca (fibrilación auricular) que han tenido hemorragia cerebral previa (hemorragia intracerebral)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to perform a RCT to resolve the long-standing management dilemma of antithrombotic stroke prevention in intracerebral haemorrhage (ICH) survivors with comorbid atrial fibrillation (AF). Specifically, it will address the question whether direct oral anticoagulants (DOACs, intervention) provide a more effective option for prevention of ischaemic stroke (IS) and an equally safe option in terms of recurrence of ICH for antithrombotic stroke prevention in survivors of recent ICH compared to no anticoagulation (i.e. no antithrombotic therapy (noAT) or antiplatelet therapy (APA) at Principal Investigator´s discretion).
    El objetivo principal es realizar un ensayo clínico aleatorizado para resolver el dilema en el manejo de la prevención antitrombótica en pacientes que han presentado una hemorragia intracerebral (HIC) afectos de fibrilación auricular (FA) comórbida. Específicamente, se va a dar respuestas a la pregunta de si los anticoagulantes orales directos (ACOD) pueden ser una opción más efectiva en la prevención de ictus isquémico en pacientes supervivientes de una HIC, comparado con no recibir tratamiento anticoagulante (no tratamiento antitrombótico (noAT) o tratamiento antiagregante, según criterio del Investigador Principal).
    E.2.2Secondary objectives of the trial
    1. To examine the effect of anticoagulation with DOAC versus no anticoagulation on major cardiovascular outcomes and mortality in ICH patient with AF
    2. To compare the effect of DOACs versus no anticoagulation on major systemic and intracranial bleeding in this Study population (safety)
    3. To examine the net clinical benefit of DOACs vs no anticoagulation in ICH patients with AF
    4. To explore the impact of antithrombotic therapy on quality of life, development of cognitive deficits and psychological morbidity in patients with ICH and AF over time
    1. Examinar el efecto de la anticoagulación con ACOD versus no anticoagulación sobre los resultados cardiovasculares y de mortalidad en pacientes con HIC y FA.
    2. Comparar el efecto de los ACOD versus no anticoagulación sobre el sangrado sistémico e intracraneal en la población del estudio (seguridad).
    3. Examinar el beneficio clínico neto de los ACOD versus no anticoagulación en pacientes con HIC y FA.
    4. Explorar el impacto de la terapia antitrombótica sobre la calidad de vida, desarrollo de déficits cognitivos y morbilidad psicológica en pacientes con HIC y FA a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Ability to provide informed consent
    3. Recent history of a non-traumatic spontaneous ICH within 15 days to 6 months before enrolment
    4. Presence of AF (paroxysmal, persistent, permanent)
    5. CHA2DS2-VASc score ≥2 for male and CHA2DS2-VASc score ≥3 for female patients [15].
    6. Availability of a brain scan performed after the ICH and before enrolment
    1. Edad ≥ 18 años.
    2. Habilidad para dar el consentimiento informado.
    3. Historia reciente de HIC espontánea, no traumática, des de 15 días hasta 6 meses antes de la inclusión al estudio.
    4. Presencia de FA (paroxística, persistente o permanente).
    5. Resultado en la escala CHA2DS2-VASc ≥2 en hombres y CHA2DS2-VASc ≥3 en mujeres.
    • Disponibilidad de una tomografía axial computarizada (TAC) de cráneo realizada tras la HIC y antes de la inclusión en el estudio.
    E.4Principal exclusion criteria
    1. Patient lacks the capacity to consent
    2. Fully dependent (modified Rankin scale >4)
    3. Women who are pregnant, breastfeeding or planning on becoming pregnant
    4. Women of childbearing potential (WOCBP 12.1) who are unable or unwilling to take measures for effective contraception (4.8)
    5. ICH occurring within the last 14 days before enrolment
    6. ICH occurring longer than 6 months before enrolment
    7. ICH resulting from trauma or vascular malformation
    8. Indication for long-term anticoagulation other than AF
    9. Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication
    10. Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per Summary of Product Charasteristics (SmPC)
    11. Absolute need for antiplatelet therapy at enrolment
    12. Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO
    13. Presence of any medical, psychological, or psychiatric condition which in the opinion of the Principal or Co-Investigator would cause participation in the Study to be unwise
    14. Participation in any clinical study with an Investigational Medicinal Product within the past 30 days (observational studies are permitted)
    1. Incapacidad para dar el Consentimiento Informado.
    2. Dependencia total (escala de Rankin modificada >4).
    3. Mujeres embarazadas, en período de lactancia o con intención de quedarse embarazadas.
    4. Mujeres con potencial de quedarse embarazadas que no pueden o no quieren adoptar medidas anticonceptivas efectivas.
    5. HIC durante los últimos 14 días antes de la inclusión en el estudio.
    6. HIC hace más de 6 meses des de la fecha de inclusión en el estudio.
    7. HIC secundaria a traumatismo o malformación vascular.
    8. Pacientes con indicación para anticoagulación a largo plazo que no sea FA.
    9. Pacientes con hipertensión que, según la opinión del investigador, no se pueda controlar con medicación.
    10. Cualquier contraindicación (excepto HIC) para el tratamiento con apixaban, dabigatran, edoxaban, rivaroxaban, según la Ficha Técnica.
    11. Necesidad absoluta de recibir tratamiento antiagregante en el momento de la inclusión.
    12. Presencia de un dispositivo de cierre de la orejuela auricular izquierda (LAAO; Left Atrial Appendage Occlusion device), o intención de implantarlo.
    13. Presencia de cualquier enfermedad médica, psicológica o psiquiátrica que, según la opinión del investigador, pueda alterar la participación en el estudio.
    14. Haber participado en un ensayo clínico con un producto medicinal en investigación durante los últimos 30 días (los estudios observacionales están permitidos).
    E.5 End points
    E.5.1Primary end point(s)
    There are two co-primary binary endpoints in the Study (evaluated by time-to-event analysis): IS and recurrent ICH. The Study will perform hierarchical testing of the two co-primary endpoints in a parallel group design
    Este ensayo clínico tiene dos variables binarias co-primarias (evaluadas mediante análisis de supervivencia): ictus isquémico y HIC recurrente. Se realizará un análisis jerárquico de las dos variables co-primarias mediante un diseño paralelo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Anytime during follow-up period the end points will be evaluated and adjudicated
    En cualquier momento durante el período de seguimiento, las variables serán evaluados
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are
    1. all stroke and systemic embolism
    2. all-cause mortality
    3. cardiovascular mortality
    4. major adverse cardiac events
    5. net clinical benefit defined as composite endpoint of all stroke, systemic embolic event, myocardial infarction, cardiovascular mortality, and major bleeding [14].
    Secondary safety endpoints comprise of
    1. any major haemorrhage according to International Society of Thrombosis and Hemostasis (ISTH) bleeding assessment tool
    2. any intracranial haemorrhage
    Las variables secundarias de eficacia son
    1. Todos los ictus y eventos embólicos sistémicos.
    2. Mortalidad por todas las causas.
    3. Mortalidad cardiovascular.
    4. Eventos adversos cardíacos mayores.
    5. Beneficio clínico neto definido como una variable compuesta de: ictus, eventos embólicos sistémicos, infarto de miocardio, mortalidad cardiovascular y hemorragia mayor.

    Las variables secundarias de seguridad son:
    1. Cualquier hemorragia mayor, definida según la escala de hemorragia de la International Society of Thrombosis and Hemostasis (ISTH).
    2. Cualquier hemorragia intracraneal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Anytime during follow-up period the end points will be evaluated and adjudicated
    En cualquier momento durante el período de seguimiento, las variables serán evaluados
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sin anticoagulación
    No anticoagulation
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 554
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 654
    F.4.2.2In the whole clinical trial 654
    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)
    The investigational medicinal products (IMPs) used in this study are marketed for stroke prevention in patients with
    atrial fibrillation. Each participant will have a final consultation with a study doctor (PI or CO-I) to discuss whether they wish to continue on their current course of treatment.
    Los medicamentos en investigación (PIM) utilizados en este estudio se comercializan para la prevención de accidentes cerebrovasculares en pacientes con fibrilación auricular. Cada participante tendrá una consulta final con un estudio médico (PI o CO-I) para discutir si desean continuar con su tratamiento actual.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA