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    Summary
    EudraCT Number:2010-023395-61
    Sponsor's Protocol Code Number:2010-ECOFA-01
    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:2010-11-29
    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 number2010-023395-61
    A.3Full title of the trial
    Estudio de la eficacia de los corticoides en la prevención de la fibrilación auricular tras cirugía cardiaca

    Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio de la eficacia de los corticoides en la prevención de la fibrilación auricular tras cirugía cardiaca
    A.4.1Sponsor's protocol code number2010-ECOFA-01
    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 SponsorIsidre Vilacosta
    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 supportFundación para la Investigación Biomédica del Hospital Clínico San Carlos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica del Hospital Clínico San Carlos
    B.5.2Functional name of contact pointSaioa Alonso
    B.5.3 Address:
    B.5.3.1Street AddressProfesor Martín Lagos S/N
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 913303413
    B.5.5Fax number+34 913303299
    B.5.6E-mailsalonsom.hcsc@salud.madrid.org
    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.2.5The 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 namemetilprednisolona
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE SODIUM SUCCINATE
    D.3.9.1CAS number 03/03/2375
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM SUCCINATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.2.5The 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 namedexametasona
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE SODIUM PHOSPHATE
    D.3.9.1CAS number 2392-39-4
    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) 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.2.5The 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 namecarvedilol
    D.3.4Pharmaceutical form Gastro-resistant 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 INNCARVEDILOL
    D.3.9.1CAS number 72956-09-3
    D.3.9.3Other descriptive nameCARVEDILOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3.125 to 12.5
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevención de la fibrilación auricular tras cirugía cardica de revascularización coronaria, valvular o ambas

    Prevention of atrial fibrillation after cardiac surgery in patients undergoing coronary artery by-pass surgery, valvular surgery or both
    E.1.1.1Medical condition in easily understood language
    Prevention of an altered type of heart rhythm (atrial fibrillation) after surgery to repair heart valves or a heart attack.
    Prevención de un tipo de ritmo alterado del corazón (fibrilación auricular) tras una operación para reparar las válvulas del corazón o por un infarto.
    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
    Evaluar la eficacia del empleo perioperatorio de corticoides intravenosos (metilprednisolona y dexametasona), añadidos al tratamiento estándar con betabloqueantes (carvedilol), para la reducción del riesgo de la fibrilación auricular postoperatoria durante los primeros 7 días en los pacientes sometidos a cirugía cardiaca (revascularización coronaria, valvular o ambas).
    E.2.2Secondary objectives of the trial
    Evaluar si el empleo perioperatorio de corticoides intravenosos (metilprednisolona y dexamtesona), añadidos al tratamiento estándar con betabloqueantes (carvedilol), en los pacientes sometidos a cirugía cardiaca de revascularización coronaria, valvular o ambas, produce una reducción de la estancia hospitalaria (calculada desde el día de la intervención hasta el alta).

    Evaluar si el empleo perioperatorio de corticoides intravenosos (metilprednisolona y dexamtesona), añadidos al tratamiento estándar con betabloqueantes (carvedilol), en los pacientes sometidos a cirugía cardiaca de revascularización coronaria, valvular o ambas, produce una reducción del riesgo de accidente cerebrovascular sintomático.

    Evaluar la seguridad del tratamiento corticoideo (metilprednisolona y dexamtesona intravenosas) en los pacientes sometidos a cirugía cardiaca de revascularización coronaria, valvular o ambas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sujetos mayores de 18 años.
    Candidato a cirugía de revascularización coronaria, cirugía valvular o la combinación de ambas.
    Estar en ritmo sinusal durante las 72 horas previas a la cirugía.
    E.4Principal exclusion criteria
    Fibrilación auricular en el momento de la inclusión o durante las 72 horas previas.
    Diabetes mellitus con mal control.
    Cualquier tipo de infección activa (urinaria, gastrointestinal, cutánea, respiratoria, etc).
    Antecedentes de tuberculosis.
    Historia de ulcus gastroduodenal activo.
    Síndrome de Cushing.
    Historia de bloqueo A-V de 2º o 3º grado.
    Portador de marcapasos o DAI.
    Alergia a corticoides.
    Tratamiento con corticoides.
    Tratamiento con fármacos antiarrítmicos con gran capacidad para prevenir la fibrilación auricular.
    E.5 End points
    E.5.1Primary end point(s)
    Como variable principal se ha elegido una variable objetiva: la aparición de fibrilación auricular, definida ésta como un ritmo en el ECG irregular, con ausencia de ondas P que son sustituidas por ondas f, y con una respuesta ventricular irregular, y frecuentemente rápida. Se reconoce como un episodio de fibrilación auricular aquél que dura al menos 30 segundos. Se ha seleccionado como medida principal de eficacia la reducción del riesgo de fibrilación auricular durante los primeros 7 días tras la cirugía.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluación a los 7 días tras la cirugía
    E.5.2Secondary end point(s)
    Evaluar si el empleo perioperatorio de corticoides intravenosos (metilprednisolona y dexamtesona), añadidos al tratamiento estándar con betabloqueantes (carvedilol), en los pacientes sometidos a cirugía cardiaca de revascularización coronaria, valvular o ambas, produce una reducción de la estancia hospitalaria (calculada desde el día de la intervención hasta el alta).
    Evaluar si el empleo perioperatorio de corticoides intravenosos (metilprednisolona y dexamtesona), añadidos al tratamiento estándar con betabloqueantes (carvedilol), en los pacientes sometidos a cirugía cardiaca de revascularización coronaria, valvular o ambas, produce una reducción del riesgo de accidente cerebrovascular sintomático.
    Evaluar la seguridad del tratamiento corticoideo (metilprednisolona y dexamtesona intravenosas) en los pacientes sometidos a cirugía cardiaca de revascularización coronaria, valvular o ambas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluación a los 7 días, al mes y a los 3 y 6 meses tras la cirugía
    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 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 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
    El final del estudio está establecido con la última visita del último paciente incluido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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)
    Los pacientes seguirán su tratamiento habitual tras el fin de su participación en el estudio
    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 Decision2011-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
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