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    Summary
    EudraCT Number:2010-022985-29
    Sponsor's Protocol Code Number:REVANT
    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:2011-02-28
    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 number2010-022985-29
    A.3Full title of the trial
    EVALUACIÓN DEL POTENCIAL DE LOS CONCENTRADOS DE FACTORES DE LA COAGULACIÓN ACTIVADOS EN LA REVERSIÓN DE LA ACCIÓN ANTICOAGULANTE DE LOS NUEVOS AGENTES ANTITROMBÓTICOS ORALES: ESTUDIOS EX VIVO EN SANGRE DE VOLUNTARIOS SANOS.
    A.4.1Sponsor's protocol code numberREVANT
    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 SponsorFundació Privada Clinic per la Recerca Biomèdica
    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 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 75 mg cápsulas duras
    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.3.4Pharmaceutical form Capsule*
    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 INNDABIGATRAN ETEXILATO MESILATO
    D.3.9.3Other descriptive nameDABIGATRAN ETEXILATO MESILATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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 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 Capsule*
    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.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
    Reversión del efecto anticoagulante de pacientes, que por su patología de base están tratados con los nuevos anticoagulantes orales: Dabigatrán y Rivaroxabán.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10019010
    E.1.2Term Trastorno hemorrágico por anticoagulantes circulantes
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo final es mejorar la seguridad y eficiencia de la práctica clínica con la nueva generación de anticoagulantes orales (Dabigatran y Rivaroxaban).
    E.2.2Secondary objectives of the trial
    1. Determinar el efecto de los nuevos anticoagulantes orales (Dabigatran y Rivaroxaban) en la hemostasia con una atención específica en las posibles interferencias con la interacción plaquetaria y los mecanismos de la coagulación bajo condiciones de flujo.
    2. Evaluar comparativamente la actividad de los concentrados conteniendo factores de la coagulación de eficacia conocida (concentrados de protrombina y FVIIar) para revertir las alteraciones de los parámetros de la hemostasia inducidas por los nuevos anticoagulantes.
    Estos últimos estudios se llevarán a cabo ex vivo en muestras de sangre obtenidas de voluntarios sanos sometidos a tratamiento anticoagulante oral a dosis de reconocida eficacia y seguridad empleadas en ensayos clínicos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Previa a la inclusión del sujeto en el estudio, el individuo debe someterse a una exploración física que será realizada por un médico del Servicio de Hemoterapia-Hemostasia en el que se valorará el estado de salud general y se descartarán la existencia de patologías que puedan afectar al estudio.
    Siempre que la exploración física esté dentro de la normalidad, el médico responsable podrá dar su aprobación para la inclusión del sujeto den el estudio.
    La inclusión del sujeto requiere el cumplimiento de los siguientes puntos:

    Edad comprendida entre 21 y 60 años
    Lectura y firma del consentimiento informado
    No existencia de historia personal de enfermedad hepática o renal
    No existencia de historia personal de diátesis hemorrágica o trombótica
    E.4Principal exclusion criteria
    Edad no comprendida entre 21 y 60 años
    Historia personal de enfermedad hepática o renal
    Historia personal de diátesis hemorrágica o trombótica
    Mujer gestante o lactante
    Mujer en edad de concebir que no utilice un método anticonceptivo eficaz
    Uso de ácido acetilsalicílico, AINES, antiagregantes o antitrombóticos (2 semanas antes del inicio del estudio)
    Uso de quinidina, ritonavir, verapamilo, claritromicina, rifampicina, fenitoína, carbamazepina, fenobarbital, amiodarona, itraconazol, voriconazol, posaconazol, ketoconazol o productos de herboristería
    Practica deporte de riesgo o contacto, viaja en bicicleta o en moto
    Donación sanguínea en los 3 meses anteriores al inicio del estudio
    El incumplimiento de alguno de los puntos anteriores o la no firma del consentimiento escrito es motivo de exclusión del sujeto. Igualmente, la apreciación por parte del médico de comportamientos que indiquen la no colaboración en el ensayo, o que el individuo presente efectos psicológicos por su participación en el ensayo como por ejemplo: miedo a los pinchazos, rechazo a medicarse, ect son también motivo de exclusión del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    -Valoración morfométrica de la interacción plaquetaria y la formación de fibrina sobre una superficie trombogénica.
    -Determinación de los niveles del fragmento F1+2 de la protrombina antes y después de la perfusión.
    -Capacidad de generación de trombina (GT).
    -Pruebas de coagulación: tiempo de protrombina y tiempo de ecarina.

    Se valorará: 1) Los decrementos en los parámetros analíticos estudiados tras el tratamiento con dabigatran o rivaroxaban; y 2) Los incrementos/mejoras en los parámetros analíticos tras la adición de concentrados de factores.
    Variables secundarias del estudio se relacionan con aspectos de seguridad como son molestias o efectos secundarios que los participantes en el estudio puedan reportar.
    Experiencia previa del equipo investigador permite anticipar que un n=10 por grupo permite un poder estadístico suficiente para establecer comparaciones entre datos apareados pre y post tratamiento para las variables primarias. Nuestro estudio no tiene potencia estadística suficiente para analizar las variables secundarias que simplemente se referirán como observaciones.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 Yes
    F.3.2Patients No
    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 state10
    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)
    Tal y como queda indicado en el protocolo después de haber finalizado el tratamiento se realiza una visita médica a los 5 días de haber finalizado el tratamiento para comprobar el estado general de salud.
    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 Decision2011-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    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
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