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    Summary
    EudraCT Number:2010-019764-36
    Sponsor's Protocol Code Number:SAP-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-02
    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.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-019764-36
    A.3Full title of the trial
    RIVAROXABAN VERSUS ACENOCUMAROL EN LA PROFILAXIS SECUNDARIA DEL SÍNDROME ANTIFOSFOLÍPIDO:UN ESTUDIO MULTICÉNTRICO, PROSPECTIVO Y RANDOMIZADO.
    A.4.1Sponsor's protocol code numberSAP-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJOSEP ORDI-ROS
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 10 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER SCHERING 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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.3Other descriptive nameRIVAROXABAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 SINTROM comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMACEUTICA, S.A.
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNACENOCUMAROL
    D.3.9.1CAS number 152-72-7
    D.3.9.3Other descriptive nameACENOCOUMAROL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Sindrome Antifosfolípido
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10002817
    E.1.2Term Síndrome antifosfolípido
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia y seguridad del tratamiento con rivaroxaban en pacientes con síndrome
    antifosfolípido (SAP).

    El objetivo principal de eficacia del estudio es demostrar que la eficacia del rivaroxaban es
    no-inferior a la dosis de acenocumarol ajustada por INR (INR 2.0-3.0 or 2.5-3.5 enaquellos pacientes con episodios tromboembólicos recurrentes a pesar de laanticoagulación) en la prevención de nuevos fenómenos trombóticos (un accidentevascular isquémico o ataque isquémico transitorio, infarto de miocardio, trombosis arterialperiférica, trombosis cerebral, TVP o TEP, o trombosis venosa en cualquier otro territorio)en el SAP durante el período de tratamiento.

    Como objetivo principal de seguridad se evaluará la incidencia de sangrado durante el
    período de tratamiento.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de eficacia y seguridad incluyen:
    -Evaluar la tolerabilidad, seguridad deltratamiento y desarrollo de efectos
    secundarios.
    -Muerte durante el período de seguimiento
    -Evaluar la incidencia de sangrado menor
    -Evaluar los parámetros inmunológicos de laboratorio (aCL, AL) durante el tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.- Edad 18 años (18 65).
    2.- Diagnóstico de un SAP definitivo ya sea primario o secundario definido según los
    criterios clasificatorios de Sidney (3).
    3.- Episodio tromboembólico venoso y/o arterial
    4.- Obtención del consentimiento informado.
    5.- Capacidad de adherirse al esquema de visitas del estudio y a los requerimientos del
    estudio.
    6.- Mujeres no embarazas y que no planeen quedarse embarazadas durante el estudio
    E.4Principal exclusion criteria
    1.- Falta de consentimiento informado.
    2.-Edad <18 años
    3.- Pacientes en edad fértil que no utilicen medidas de contracepción, embarazo o
    lactancia o aquellos pacientes que planeen una gestación durante el estudio.
    4.- Historia conocida de hipersensibilidad a uno de los principios.
    5.- Hemorragia cerebral o gastrointestinal en los 6 meses previos.
    6.- Neurocirugía en las 4 semanas previas a la inclusión u otro tipo de cirugía en los
    últimos 10 días.
    7.- Úlcera péptica activa
    8.-Evidencia de una alteración analítica, en los 30 días antes de la inclusión en el estudio
    . Plaquetas <30x10E9 cells/L
    . GOT o GPT120 ui/mL (>3xULN)
    9.- Enfermedad maligna activa (excluyendo neoplasia cervical intra-epitelial o neoplasia
    dermatológica)
    10- Evidencia de enfermedad renal actual (FGR<30 mL/min) o síntomas de enfermedad
    renal progresiva o poco controlada.
    11.- Cualquier otra condición médica relevante, incluyendo alteraciones analíticas, que
    pudiera poner al paciente en situación de riesgo pudiera dificultar la capacidad de
    interpretar los datos del estudio.
    12.- Severa Hipertensión Arterial no controlada (180/100 mmHg) o Tensión Arterial
    sistólica>180 mmHg o TA diastólica >110 mmHg.
    13. Fase aguda de un evento trombótico (< 6 meses desde el evento trombótico)
    14. Sangrado activo o riesgo elevado de sangrado que contraindique el tratamiento con
    heparina de bajo peso molecular o vitamina K antagonistas.
    15.- La presencia de cualquier otra contraindicación listada en la etiqueta de la warfarina,acenocumarol o rivaroxaban.
    16. Anti-inflamatorios no esteroidos (AINES) con una vida media17 horas, o el uso
    concomitante de fuertes inhibidores de CYP3A4 (por ejemplo inhibidores de las
    proteasas en HIV, ketoconazol sistémico) o inductores del CYP3A4 como la
    rifampicina.
    17.- Infeccion por HIV o virus de la hepatitis B o C
    18.- Hepatopatía crónica (Child Plugh B) con coagulopatía o Child Plugh C .
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es el desarrollo de un nuevo evento trombótico durante el
    período de estudio.
    Definición de eventos trombóticos: 1. Accidente vascular isquémico trombótico: Se definirá
    como la presencia de un evento neurológico clínico confirmado por estudios de neuroimagen
    como la tomografía (TAC) o la Resonancia magnética nuclear (RMN). 2. Trombosis venosa
    profunda: Se definirá por una clínica compatible del evento confirmada por un Eco Doppler o
    una venografía. 3. Tromboembolismo Pulmonar (TEP): Se definirá como un resultado positivo
    de una gammagrafía pulmonar de Ventilación/perfusión o un angio-TAC ante la presencia de
    síntomas típicos como son un dolor pleurítico, disnea o hemoptisis. 4. Infarto Agudo de
    Miocardio (IAM): se definirá como la presencia de cambios electrocardiográficos diagnósticos,
    elevación de los enzimas cardiacos en presencia de unos síntomas típicos o una angiografía
    coronaria. 5. Cualquier otro evento vascular se confirmara por un criterio validado objetivo como
    se requiere por los criterios clasificatorios de Sidney del SAP.
    La variable principal de seguridad es el desarrollo de hemorragia mayor durante el periodode estudio:
    La definición de sangrado mayor según la Sociedad Internacional de Trombosis y
    Hemostasia de sangrado en pacientes no quirúrgicos (33) se definirá como un sangrado
    agudo clínicamente evidente acompañado por uno o más de los siguientes eventos: Un
    descenso en el nivel de hemoglobina de 2 g por decilitro o más dentro de un periodo de 24
    horas; requerimiento de una transfusión de 2 o más concentrados de hematíes; sangrado en
    una localización critica ; sangrado en una articulación intervenida que requiera una reintervención; sangrado intramuscular que conlleve un síndrome compartimental;
    sangrado mortal.
    b) Variables secundarias:
    -Desarrollo de efectos secundarios.
    - Desarrollo de hemorragia menor definida como un sangrado agudo clínicamente
    evidente como un hematoma de la herida, hematomas o equimosis, sangrado
    gastrointestinal, hemoptisis, hematuria, o epistaxis que no cumplan los criterios de
    sangrado mayor.
    -Muerte debida a cualquier causa
    -Valoración de los parámetros inmunológicos (aFL)
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 No
    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 state218
    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 Decision2011-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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