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    Summary
    EudraCT Number:2009-018173-31
    Sponsor's Protocol Code Number:POISE-2
    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:2010-01-08
    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 number2009-018173-31
    A.3Full title of the trial
    Ensayo clínico factorial de clonidina y aspirina en pacientes que van a ser sometidos a cirugía no cardiaca y que estén en riesgo moderado o alto de sufrir eventos cardíacos perioperatorios (Estudio POISE-2)
    A.3.2Name or abbreviated title of the trial where available
    POISE-2
    A.4.1Sponsor's protocol code numberPOISE-2
    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 Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    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 ADIRO 100 mg comprimidos recubiertos
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HISPANIA, S.L.
    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 Coated 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 INNACETILSALICILICO ACIDO
    D.3.9.1CAS number 50-78-2
    D.3.9.3Other descriptive nameACETILSALICILICO ACIDO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 CATAPRESAN comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNCLONIDINA HIDROCLORURO
    D.3.9.1CAS number 4205-91-8
    D.3.9.3Other descriptive nameCLONIDINE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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: 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.2.1.1.1Trade name CATAPRES Transdermal
    D.2.1.1.2Name of the Marketing Authorisation holderBOHERINGER INGELHEIM
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINA HIDROCLORURO
    D.3.9.1CAS number 4205-91-8
    D.3.9.3Other descriptive nameCLONIDINE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevención de episodios cardiovasculares en pacientes de moderado a alto riesgo cardiovascular que son sometidos a una cirugía no cardiaca.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10007649
    E.1.2Term Cardiovascular disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar el impacto de la administración perioperatoria de aspirina y/o clonidina sobre los eventos cardiovasculares (definidos como muerte cardiovascular, infarto del miocardio no fatal y parada cardiaca no fatal) en los primeros 30 días postquirúrgicos en pacientes con moderado o alto riesgo cardiovascular que son sometidos a cirugía no cardiaca.
    E.2.2Secondary objectives of the trial
    De forma adicional, también se evaluará el efecto a largo plazo (1 año) sobre el riesgo de eventos cardiovasculares, así como la estancia hospitalaria o en cuidados intensivos, entre otras, y la seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Todos los pacientes sometidos a cirugía no cardiaca son elegibles si:
    1) Tienen &#8805; 45 años.
    2) Tienen una expectativa de estancia postoperatoria &#8805; 24 horas por causas quirúrgicas.
    3) Cumplen cualquiera de los siguientes 6 criterios:
    A.- Antecedentes de enfermedad coronaria definida por uno o más de los siguientes 6 criterios: i) Antecedentes de angina; ii) Antecedente de infarto de miocardio; iii) Prueba de esfuerzo positiva previa; iv) Isquemia cardiaca documentada por pruebas de estrés nuclear o ecografía de estrés previa; v) Angiografía coronaria previa que evidencie estenosis por ateroesclerosis mayor del 50% del diámetro arterial; vi) Ondas Q patológicas en ECG en dos derivaciones continuas.
    B.- Enfermedad vascular arterial definida con uno o más de los siguientes tres criterios: i) Claudicación intermitente (dolor en las piernas al caminar que desaparece dentro de los primeros 10 minutos del reposo), probablemente secundaria a enfermedad ateroesclerótica; ii) Índice tobillo/brazo mayor de 0,90 en cualquiera de las piernas en reposo; iii) Angiografía o estudio doppler que demuestre una estenosis mayor de 70%.
    C.- Antecedentes de accidente cerebrovascular (déficit neurológico focal que persiste por al menos 1 semana) debido a enfermedad aterotrombótica (No un infarto lacunar, hemorrágico, ni tromboembólico secundaria a fibrilación auricular)
    D.- Hospitalización por insuficiencia cardiaca congestiva dentro de los 3 años anteriores a la aleatorización (no de etiología Chagásica o de origen valvular por fiebre reumática)
    E.- Pacientes que van a ser sometidos a cirugía vascular (excluyendo cirugía por fístula arteriovenosa para diálisis, varicectomias, y endarterectomías carotídeas)
    F.- Pacientes con 3 de cualquiera de los siguientes 7 factores de riesgo: i) Cirugía de alto riesgo ( intratorácica o intraperitoneal); ii) Cualquier antecedente de insuficiencia cardiaca; iii) Diabetes en tratamiento con terapia oral o insulina; iv) Creatinina perioperatoria >2.0 mg/dl; v) Edad mayor de 70 años; vi) Antecedentes de accidente isquémico transitorio (déficit focal pasajero que perdura menos de 24 horas y de probable origen vascular); vii) Cirugía de urgencia (cirugía que debe ser llevada a cabo dentro de las primeras 24 horas del comienzo del cuadro agudo en el hospital).
    E.4Principal exclusion criteria
    1. Consumo de ASA en las 72 horas previas a la cirugía;
    2. Hipersensibilidad o alergia conocida al ASA o clonidina;
    3. Presión arterial sistólica < 105 mm Hg;
    4. Frecuencia cardiaca < 55 latidos por minuto en un paciente que no es portador de un marcapasos;
    5. Bloqueo cardíaco de segundo o tercer grado en un paciente que no es portador de un marcapasos;
    6. Úlcera péptica activa;
    7. Colocación de un stent coronario liberador de fármacos en el año previo a la aleatorización;
    8. Colocación de un stent metálico en las 6 semanas previas a la aleatorización;
    9. Consumo actual de un agonista-alfa 2, alfa metildopa, reserpina, clopidogrel, o ticlopidina;
    10. Paciente que va a ser sometido a cirugía intracraneal, endarterectomía carotídea o cirugía de retina;
    11. Paciente que no otorga el consentimiento informado previamente a la cirugía; O
    12. Paciente ya reclutado con anterioridad en el estudio POISE-2.
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de eventos cardiovasculares (definidos como muerte cardiovascular, infarto del miocardio no fatal y parada cardiaca no fatal) en los primeros 30 días después de 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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Factorial
    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 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 No
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El estudio finalizará al completarse 1 año de seguimiento 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
    E.8.9.2In all countries concerned by the trial years4
    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.1.3Elderly (>=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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10000
    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)
    Se proporcionarán los cuidados habituales según criterio médico y las pautas establecidas en cada centro.
    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 Decision2011-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
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