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    Summary
    EudraCT Number:2017-003342-25
    Sponsor's Protocol Code Number:P170604J
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-05-08
    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 number2017-003342-25
    A.3Full title of the trial
    Long-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis
    Tratamiento a largo plazo del TEV asociado al cáncer: dosis reducida respecto a dosis completa de apixaban: Estudio API-CAT con apixaban en la trombosis asociada al cáncer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis
    Tratamiento a largo plazo del TEV asociado al cáncer: dosis reducida respecto a dosis completa de apixaban: Estudio API-CAT con apixaban en la trombosis asociada al cáncer
    A.3.2Name or abbreviated title of the trial where available
    API-CAT
    A.4.1Sponsor's protocol code numberP170604J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 supportBristol Myers Squibb SARL
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailaurelie.zindjirdjian@aphp.fr
    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 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 5mg
    D.3.4Pharmaceutical form 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.3.9.1CAS number 503612-47-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 ELIQUIS 2,5mg
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 2,5mg
    D.3.4Pharmaceutical form 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.3.9.1CAS number 503612-47-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis) with objectively documented index event of symptomatic or incidental proximal DVT or symptomatic or incidental PE, after at least 6 months of anticoagulant therapy for the treatment of the index event, with no objectively documented symptomatic recurrence of VTE between the index event and randomization.
    Cualquier cáncer diagnosticado histológicamente (que no sea un carcinoma de células basales o de células escamosas de la piel, un tumor cerebral primario o metástasis intra-cerebrales) con un evento índice documentado objetivamente de TVP sintomática o incidental proximal o EP sintomática o incidental, después de al menos 6 meses de terapia anticoagulante para el tratamiento del evento índice, sinrecurrencia sintomática documentada objetivamente de TEV entre el evento índice y la aleatorización.
    E.1.1.1Medical condition in easily understood language
    Venous thrombosis or pulmonary embolism, with cancer
    Trombosis venosa o embolia pulmonar, con cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076654
    E.1.2Term Cancer-associated thrombosis
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether a low-dose regimen of apixaban (2.5 mg bid) is non-inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (PE) (symptomatic or incidental).
    Para determinar si un régimen de dosis baja de apixaban (2,5 mg dos veces al día) es no inferior a un régimen de dosis completa de apixaban (5 mg dos veces al día) para la prevención del TEV en pacientes con cáncer que hayan completado al menos durante 6 meses un tratamiento anticoagulante para el tratamiento de un evento índice documentado de trombosis venosa profunda proximal (TVP) (sintomática o incidental) o embolia pulmonar (EP) (sintomática o incidental).
    E.2.2Secondary objectives of the trial
    The key secondary objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is safer than a full dose regimen of apixaban (5 mg bid) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal DVT (symptomatic or incidental) or PE (symptomatic or incidental).

    Other secondary objectives
    To compare treatment effects of the reduced apixaban doses relative to full dose for the following:
    - recurrent symptomatic VTE ;
    - VTE-related death ;
    - all-cause death ;
    - major bleeding.
    El objetivo secundario clave es determinar si un régimen de dosis baja de apixaban (2,5 mg dos veces al día) es más seguro que un régimen de dosis completa de apixaban (5 mg dos veces al día) en pacientes con cáncer activo que hayan completado al menos 6 meses de tratamiento anticoagulante para el tratamiento de un evento índice documentado de TVP proximal (sintomática o incidental) o EP (sintomática o incidental).

    Otros objetivos secundarios
    Comparar los efectos del tratamiento de la dosis reducida de apixaban con la dosis completa para:
    - TEV sintomático recurrente;
    - Muerte relacionada con TEV;
    - Muerte por todas las causas;
    - Hemorragia grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Written Informed Consent

    - Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis

    - Active cancer defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy, hormonotherapy, targeted therapy, immunotherapy at inclusion.

    - Objectively documented index event of :
    symptomatic or incidental proximal lower-limb, iliac, inferior cava vena DVT or symptomatic or incidental PE in a segmental or larger pulmonary artery
    (1) Proximal DVT is defined as DVT that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography or contrast enhanced computed tomography or magnetic resonance imaging.
    (2) PE has to be demonstrated by imaging as follows:
    an intraluminal filling defect in segmental or more proximal branches on contrast enhanced chest computed tomography or on computed tomography pulmonary angiography ; or
    an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or
    a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
    (3) Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of his or her malignancy or other reasons but not for a VTE suspicion(e.g. cancer diagnosis or staging).

    - At least 6 months of anticoagulant therapy at therapeutic dosage (whatever the drug and the dosing), or completed assigned a clinical trial study treatment, for the treatment of the index event; and patient still receiving anticoagulant treatment after occurrence or the VTE index event.

    - No objectively documented symptomatic recurrence of VTE between the index event and randomization.

    - Anticipated duration of anticoagulant treatment of at least 12 months at the time of randomization.

    - Patient affiliated to social security for French centers.
    - Consentimiento informado escrito y firmado

    - Cualquier cáncer diagnosticado histológicamente (que no sea un carcinoma de células basales o de células escamosas de la piel, un tumor cerebral primario o metástasis intra-cerebrales)

    - Cáncer activo definido como la presencia de enfermedad medible o quimioterapia, radioterapia, hormonoterapia, terapia dirigida o inmunoterapia en curso (o planificada) en el momento de la inclusión.

    - Evento índice documentado objetivamente de:
    TVP sintomática o incidental proximal de miembro inferior, ilíaco, vena cava inferior o EP sintomática o incidental en una arteria pulmonar segmentaria o más grande
    (1) La TVP proximal se define como una TVP que implica al menos la vena poplítea o una vena más proximal, demostrada por imágenes mediante ultrasonidos por compresión (CUS), incluido Doppler en escala de grises o codificado por color, o venografía ascendente con contraste o tomografía computarizada mejorada del tórax o imágenes de resonancia magnética.
    (2) La EP debe demostrarse mediante imágenes de la siguiente forma:
    -defecto de relleno intraluminal en las ramas segmentarias o más proximales en tomografía computarizada mejorada del tórax con contraste o en la angiografía pulmonar por tomografía computarizada; o
    -defecto de llenado intraluminal o corte repentino de vasos de más de 2,5 mm de diámetro en el angiograma pulmonar; o
    - defecto de perfusión de al menos el 75% de un segmento con un resultado de ventilación local normal (alta probabilidad) en la gammagrafía pulmonar de ventilación/perfusión (VPLS)
    (3) El TEV incidental se define como TVP o EP proximal detectado por imágenes de forma incidental cuando un paciente se somete a estudios por imágenes como norma de atención para el tratamiento de su neoplasia o por otras razones, pero no por una sospecha de TEV (por ej., diagnóstico o estadificación del cáncer).

    - Al menos 6 meses de terapia anticoagulante a la dosificación terapéutica (cualquiera que sea el medicamento y la dosificación), o un tratamiento de estudio de ensayo clínico asignado completo, para el tratamiento del evento índice; y el paciente que sigue recibiendo tratamiento anticoagulante después de la ocurrencia o el evento índice de TEV.

    - Ninguna recurrencia sintomática documentada objetivamente de TEV entre el evento índice y la aleatorización.

    - Duración prevista del tratamiento anticoagulante de al menos 12 meses en el momento de la aleatorización.

    - Paciente afiliado a la seguridad social para centros franceses.
    E.4Principal exclusion criteria
    - WOCBP who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study

    - Women who are pregnant or breastfeeding

    - Women with a positive pregnancy test on enrollment or prior to investigational product administration

    - Isolated sub-segmental incidental or symptomatic PE without associated DVT

    - Isolated distal DVT of the legs

    - Isolated upper-extremity DVT or superior vena cava thrombosis

    - Isolated visceral thrombosis

    - Isolated catheter thrombosis

    - Objectively documented symptomatic recurrence of VTE after the index event under anticoagulant treatment

    - VTE during anticoagulant treatment given at therapeutic dosage

    - Subjects with indications for long-term treatment with a VKA, such as:
    -Mechanical heart valve
    -Antiphospholipid syndrome

    - Subjects with indication for long-term anticoagulation with a VKA or a DOAC at therapeutic dosage

    - Conditions increasing the risk of serious bleeding
    -intracranial or intraocular bleeding within the 6 months ;
    -major surgery within 2 weeks prior to randomization;
    -overt major bleeding at time of randomization.

    - Life expectancy < 12 months

    - Eastern Cooperative Oncology Group (ECOG) level 3 or 4

    - Bacterial endocarditis

    - Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg

    - Platelet count <75,000/mm3;

    - Hemoglobin < 8g /dl

    - Creatinine clearance < 30 ml /min based on the Cockcroft Gault equation; (see Section 5.9.2);

    - Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range

    - Subjects requiring ASA >165 mg/day at randomization or thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor).

    - Subjects requiring dual anti-platelet therapy (such as ASA plus clopidogrel or ASA plus ticlopidine) at randomization. Subjects who transition from dual antiplatelet therapy to monotherapy prior to randomization will be eligible for the trial.

    - Concomitant use of strong inhibitors of both cytochrome P-450 3A4 and P Glycoprotein (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole) or strong inducers of both cytochrome P-450 3A4 and P Glycoprotein (e.g., rifampicin, carbamazepine, or phenytoin).

    - Prisoners or subjects who are involuntarily incarcerated

    - Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

    - Hypersensitivity to apixaban

    - Subjects participating in another pharmaco therapeutic program with an experimental therapy that is known to affect the coagulation system

    - Under 18 years old ;

    - Patients under legal protection (guardianship)
    - Las mujeres en edad fértil que no quieren o no pueden utilizar un método anticonceptivo aceptable [como anticonceptivos orales, otros anticonceptivos hormonales (productos vaginales, parches cutáneos o productos implantados o inyectables), o productos mecánicos como un dispositivo intrauterino o métodos de barrera (condones)] para evitar el embarazo durante todo el estudio.

    - Mujeres embarazadas o en período de lactancia

    - Mujeres con una prueba de embarazo positiva en el momento de la inscripción o antes de la administración del producto investigado

    - EP con subsegmentos aislados (incidentales o sintomáticos) sin TVP asociada

    - TVP distal aislada de las piernas

    - TVP de los miembros superiores aislada o trombosis de la vena cava superior

    - Trombosis visceral aislada

    - Trombosis aislada del catéter

    - Recurrencia sintomática objetivamente documentada de TEV después de evento índice bajo tratamiento anticoagulante

    - TEV durante el tratamiento anticoagulante administrado en dosis terapéuticas

    - Sujetos con indicaciones para un tratamiento a largo plazo con VKA, como:
    -Válvula cardíaca mecánica
    -Síndrome antifosfolípido

    - Sujetos con indicación de anticoagulación a largo plazo con antagonistas de la vitamina K (VKA) o anticoagulantes orales directos (DOAC) en dosificación terapéutica

    - Condiciones que aumentan el riesgo de hemorragia grave
    -sangrado intracraneal o intraocular durante los 6 meses
    -cirugía principal en las 2 semanas previas a la aleatorización
    -hemorragia grave manifiesta en el momento de la aleatorización

    - Esperanza de vida < 12 meses

    - Nivel 3 o 4 de la escala ECOG (Eastern Cooperative Oncology Group)

    - Endocarditis bacteriana

    - Hipertensión no controlada: presión arterial sistólica >180 mm Hg o presión arterial diastólica >110 mm Hg

    - Recuento de plaquetas < 75.000/mm3

    - Hemoglobina < 8g /dl

    - Aclaramiento de creatinina < 30 ml /min basado en la ecuación de Cockcroft Gault (ver Apartado 5.7.4)

    - Hepatitis aguda, hepatitis activa crónica, cirrosis hepática; o un nivel de alanina aminotransferasa 3 veces o más y/o un nivel de bilirrubina 2 veces o más, superior al límite máximo del rango normal

    - Sujetos que requieren ASA >165 mg/día en la asignación al azar o terapia con tienopiridina (clopidogrel, prasugrel o ticagrelor)

    - Sujetos que requieren terapia antiplaquetaria dual (como ácido acetilsalicílico más clopidogrel o ácido acetilsalicílico más ticlopidina) en la asignación al azar. Los sujetos que hagan la transición del tratamiento antiplaquetario dual a la monoterapia antes de la asignación al azar serán elegibles para el ensayo.

    - Uso concomitante de inhibidores fuertes de citocromo P-450 3A4 y Glicoproteína P por ej., inhibidores de la proteasa del virus de la inmunodeficiencia humana o ketoconazol sistémico) o inductores fuertes tanto de citocromo P-450 3A4 como de glicoproteína P (por ej., rifampicina, carbamazepina o fenitoína).

    - Presos o sujetos que están encarcelados involuntariamente

    - Sujetos detenidos obligatoriamente para el tratamiento de una enfermedad psiquiátrica o física (por ej., enfermedad infecciosa)

    - Hipersensibilidad al apixaban

    - Sujetos que participen en otro programa farmacoterapéutico con una terapia experimental de la que se conoce que afecta al sistema de coagulación

    - Menores de 18 años

    - Pacientes bajo protección legal (tutela)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the incidence of an adjudicated composite of recurrent symptomatic VTE (proximal and/or distal DVT and/or symptomatic PE and/or upper limb or CVC thrombosis) or incidental VTE (proximal DVT or PE), or death due to PE during the treatment period.
    El criterio primario de valoración de la eficacia es la incidencia de un compuesto evaluado de un TEV sintomático recurrente (TVP proximal y/o distal y/o EP sintomática y/o trombosis de miembro superior o de CVC) o TEV incidental (TVP proximal o EP), o muerte por EP durante el período de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    The key secondary outcome is the incidence of adjudicated major and clinically relevant non-major bleeding during the treatment period.

    Other secondary endpoints:
    Adjudicated composite of :
    - Recurrent symptomatic VTE ;
    - VTE related-death ;
    - All-cause death: all deaths will be adjudicated by the ICAC and classified as either VTE-related, cancer death (including all deaths due to the underlying cancer), bleeding-related or others, including all deaths due to a clearly documented other cause, such as for example respiratory failure (e.g., terminal emphysema), infections/sepsis, etc. ;
    - Adjudicated major bleeding.
    El resultado secundario clave es la incidencia de hemorragias mayores y no mayores clínicamente relevantes observadas durante el período de tratamiento.

    Otros criterios secundarios de valoración:
    Compuesto evaluado de:
    - TEV sintomático recurrente;
    - Muerte relacionada con TEV;
    - Muerte por todas las causas;todas las muertes clasificadas como relacionadas con TEV, muerte por cáncer (incluidas todas las muertes debidas al cáncer subyacente), relacionadas con hemorragias u otras, incluidas todas las muertes debidas a otra causa claramente documentada, como por ejemplo insuficiencia respiratoria (por ej., enfisema terminal), infecciones/septicemia, etc. ;
    - Hemorragia mayor adjudicada.
    E.5.2.1Timepoint(s) of evaluation of this end point
    13 months
    13 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA155
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Greece
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial 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
    Última Visita Último Sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 1722
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-05-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1680
    F.4.2.2In the whole clinical trial 1722
    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)
    Anticoagulant treatment, at the investigator's discretion
    Tratamiento anticoagulante, a criterio del investigador.
    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 Decision2019-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-27
    P. End of Trial
    P.End of Trial StatusRestarted
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