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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2009-011964-12
    Sponsor's Protocol Code Number:PROFACE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-07
    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 number2009-011964-12
    A.3Full title of the trial
    Uso de atorvastatina como profilaxis de la fibrilación auricular en el postoperatorio de la cirugía cardiaca
    A.3.2Name or abbreviated title of the trial where available
    PROFACE
    A.4.1Sponsor's protocol code numberPROFACE
    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 SponsorFundación General de la Universidad de Valladolid
    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 CARDYL 40 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, 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 INNATORVASTATINA CALCICA TRIHIDRATO
    D.3.9.3Other descriptive nameATORVASTATINA CALCICA TRIHIDRATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Fibrilación Auricular
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de la administración de atorvastatina durante el preoperatorio y el postoperatorio inmediatos como profilaxis de la Fibrilación Auricular en el postoperatorio de la cirugía cardiaca en una población de pacientes valvulares (con o sin patología coronaria asociada), en ritmo sinusal, sin antecedentes de FA y que no estén previamente en tratamiento con beta-bloqueantes ni estatinas.
    E.2.2Secondary objectives of the trial
    1. Evaluar existencia de correlación entre marcadores inflamación alterados durante CEC y predisposición a FA en postoperatorio.
    2. Determinar marcadores bioquímicos modificados por administración de estatinas, para conocer mecanismo(s) de acción de las mismas sobre proceso de remodelado atrial inductor de FA.
    3. Identificar si administración preoperatoria de estatinas produce modificaciones en parámetros ecocardiográficos identificados como predisponentes para aparición de FA postoperatoria.
    4. Determinar frecuencia, duración, características y factores de riesgo de FA en postoperatorio de pacientes valvulares (sin antecedentes de arritmia) sometidos a cirugía cardiaca.
    5. Evaluar consecuencias clínicas y hemodinámicas secundarias a episodios de FA en postoperatorio de cirugía cardiaca.
    6. Cuantificar repercusión económica de FA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres y mujeres mayores de edad.
    2. En ritmo sinusal.
    3. Afectados por patología valvular aislada o asociada a enfermedad coronaria con criterios para intervención con CEC.
    4. Las mujeres en edad fértil deben emplear un método anticonceptivo eficaz y deben comprometerse a mantenerlo a lo largo de todo el estudio
    E.4Principal exclusion criteria
    1. Cirugía urgente.
    2. Cirugía por endocarditis.
    3. Pacientes con episodios previos de FA, aunque se encuentren en ritmo sinusal en el momento del ingreso.
    4. Tratamiento preoperatorio con beta-bloqueantes en el momento de la aleatorización
    5. Disfunción severa ventricular izquierda con fracción de eyección ventricular inferior al 30%.
    6. Toma crónica de antiinflamatorios no esteroideos y/o corticoides en el momento de la aleatorización
    7. Enfermedad tiroidea no controlada.
    8. Enfermedad hepática activa y/o antecedente de hepatopatía crónica previa.
    9. Alcoholismo.
    10. En función de posibilidad de efectos adversos de las estatinas:
    a. Elevación de cifras basales de transaminasas (x3 respecto al valor normal).
    b. Insuficiencia renal con creatinina superior a 2 mg/dl.
    c. Diagnóstico previo de miopatía de cualquier etiología.
    11. No firmar el consentimiento informado.
    12. Incapacidad de comprensión de los objetivos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Aparición durante la estancia hospitalaria de episodios de FA de duración igual o superior a 5 minutos, o aquellos de duración inferior pero con repercusión hemodinámica o clínica. Para su identificación, los pacientes estarán monitorizados mediante telemetría durante el postoperatorio tanto en Unidad de Reanimación como en planta de hospitalización.
    2. Factores de riesgo para la aparición de FA en el postoperatorio de nuestros pacientes valvulares.
    3. Tiempo (en horas) desde la intervención quirúrgica hasta la aparición de FA.
    4. Duración del (los) episodio(s) de FA (en minutos u horas).
    5. Eventos mayores cardiológicos asociados a su aparición: bajo gasto cardiaco, hipotensión arterial? durante el postoperatorio intrahospitalario.
    6. Eventos mayores de tipo neurológico: accidente isquémico transitorio, accidente cerebrovascular postoperatorio, crisis convulsiva y/o coma.
    7. Fenómenos embólicos de otras localizaciones.
    8. Duración (en días) de estancia en Unidad de Reanimación y en planta de hospitalización.
    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 No
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Grupo sin tratamiento
    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
    Alta del último paciente reclutado
    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) Yes
    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 state246
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 246
    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 Decision2010-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 01 23:44:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA