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    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).

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    Summary
    EudraCT Number:2009-017454-12
    Sponsor's Protocol Code Number:U01-NS052220
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2011-01-21
    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 number2009-017454-12
    A.3Full title of the trial
    PROTOCOLO DEL ENSAYO CLÍNICO DE TRATAMIENTO INTERVENCIONISTA DEL ICTUS (INTERVENTIONAL MANAGEMENT OF STROKE)

    Ensayo clínico de fase III, aleatorizado, multicéntrico, en abierto, con 900 sujetos, para determinar si una estrategia repermeabilizadora intravenosa e intraarterial combinada es mejor que el tratamiento habitual exclusivamente intravenoso con rt-PA (Activase®/Actilyse®) cuando se instaura en las tres horas siguientes al inicio de un ictus isquémico agudo.
    A.3.2Name or abbreviated title of the trial where available
    IMS III
    A.4.1Sponsor's protocol code numberU01-NS052220
    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 SponsorUniversity of Cincinnati - Academic Medical Center -Department of Neurology
    B.1.3.4CountryUnited States
    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 ACTILYSE polvo y disolvente para solución inyectable y para perfusión
    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 Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarterial use
    Parenteral use (Noncurrent)
    Intravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALTEPLASA
    D.3.9.1CAS number 9001-91-6
    D.3.9.3Other descriptive nameALTEPLASE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeLa alteplasa es producida mediante la técnica de ADN recombinante, utilizando una línea celular ovárica de hamster chino.
    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 ACTILYSE polvo y disolvente para solución inyectable y para perfusión
    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 Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALTEPLASA
    D.3.9.1CAS number 9001-91-6
    D.3.9.3Other descriptive nameALTEPLASE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeLa alteplasa es producida mediante la técnica de ADN recombinante, utilizando una línea celular ovárica de hamster chino.
    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
    Accidente cerebrovascular isquémico
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Accidente cerebrovascular isquémico
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10065528
    E.1.2Term Puntuación en la escala de accidente cerebrovascular de NIH aumentada
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si los sujetos que han sufrido un ictus isquémico y cuya puntuación basal en la escala de ictus de los NIH (apéndice A [NIHSSS]) es 10 (8-9 con angiotomografía positiva) que son tratados con activador recombinante tisular del plasminógeno (rt-PA; [alteplasa recombinante] Activase® de Genentech, Inc., Actilyse® de Boehringer Ingelheim) mediante una estrategia repermeabilizadora combinada de administración intravenosa más administración intraarterial (IV/IA) en las 3 horas posteriores al inicio del ictus tienen más probabilidades de presentar a los 3 meses un resultado favorable (es decir, que el sujeto presente una puntuación de la escala de Rankin modificada (apéndice B [ERm]) de 0 a 2) comparado con los sujetos tratados con el rt-PA intravenoso habitual solo.
    E.2.2Secondary objectives of the trial
    1.Comparar la seguridad de la estrategia combinada IV/IA frente a la del rt-PA por vía IV solo. Las variables principales de seguridad serán la mortalidad a los 3 meses y la aparición de hemorragia intracraneal (HIC) sintomática iatrógena confirmada en un plazo de 24 horas
    2. Comparar mediante diversas variables secundarias la eficacia de la estrategia combinada IV/IA frente al tratamiento habitual con rt-PA IV
    3. Comparar el coste-eficacia de la estrategia combinada IV/IA frente al del rt-PA IV habitual según las diferencias intergrupales en el uso de recursos sanitarios y en la calidad de vida durante 12 meses
    4. Desarrollar y mantener una red de centros intervencionistas para estudiar la seguridad, la viabilidad y la posible eficacia de nuevos dispositivos mecánicos que puedan incorporarse a una estrategia repermeabilizadora combinada IV/IA a medida que vaya avanzando el estudio IMS III.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Edad: entre 18 y 82 años (esto significa que los candidatos deben haber cumplido 18 años pero no 83)
    2. Inicio de administración de rt-PA intravenoso dentro de las 3 horas del inicio de los síntomas del ictus. La hora del comienzo se define como la última vez en que se estableció que el sujeto estaba en estado basal
    3. Un valor en la escala de ictus del NIH > 10 al momento de iniciar la administración intravenosa de rt-PA o un valor en la escala de ictus del NIH >7 y <10 con una oclusión detectada en M1, en la arteria carótida interna o en la arteria basilar al realizar una angiografía por tomografía computarizada en aquellas instituciones donde el diagnóstico por imágenes mediante angiografía basal por tomografía computarizada es la norma de atención médica para pacientes con ictus agudo.
    4. Verificación del investigador que el sujeto ha recibido/está recibiendo la dosis adecuada de rt-PA por vía IV conforme al peso estimado, con anterioridad a la asignación aleatoria
    E.4Principal exclusion criteria
    1. Historia de ictus durante los 3 meses anteriores
    2. Antecedentes de hemorragia intracraneal, neoplasma, hemorragia subaracnoidea o malformación arteriovenosa
    3. Presentación clínica que sugiera hemorragia subaracnoidea, aunque la tomografía computarizada (TC) inicial sea normal
    4. Hipertensión al momento del tratamiento; presión arterial sistólica > 185 o diastólica > 110 mm Hg) o necesidad de medidas agresivas para disminuir la presión arterial por debajo de estos límites
    5. Presunción de émbolo séptico o sospecha de endocarditis bacteriana
    6. Presunción de pericarditis, que incluye pericarditis después de infarto agudo de miocardio
    7. Sospecha de disección aórtica
    8. Cirugía o biopsia de órgano parenquimatoso reciente (dentro de los 30 días previos)
    9. Traumatismo con lesiones internas o con heridas ulcerosas reciente (dentro de los 30 días previos)
    10. Traumatismo craneoencefálico grave o con pérdida de conciencia reciente (dentro de los 90 días previos)
    11. Cualquier hemorragia activa o reciente (dentro de los 30 días previos)
    12. Pacientes con diátesis hemorrágica conocida, tanto hereditaria como adquirida, deficiencia del factor de coagulación o tratamiento anticoagulante por vía oral que requiere resultados de análisis de laboratorio de coagulación antes de la inclusión. Se excluye a los sujetos con IIN > 1.7 o con tiempo de protrombina equivalente a nivel institucional. Para pacientes sin antecedentes o sospecha de coagulopatía no se requiere que haya resultados de laboratorio de tiempo de protrombina o IIN antes de su inclusión
    13. Mujeres en edad reproductiva embarazadas o lactantes o con pruebas de embarazo con resultado positivo
    14. Valores de laboratorio basales: glucosa < 50 mg/dl ó > 400 mg/dl, plaquetas <100,000 ó Hct <25%
    15. Sujeto que requiere hemodiálisis o diálisis peritoneal o con contraindicación para angiograma
    16. Sujetos a quienes se les administró heparina o un inhibidor directo de trombina (Angiomax, argatroban, Refludan) dentro de las 48 horas deben presentar tiempo de tromboplastina parcial (TTP) normal para reunir los requisitos necesarios para participar en el estudio
    17. Sujetos con punción arterial en lugar no accesible a la compresión o punción lumbar dentro de los 7 días previos
    18. Sujetos con crisis comiciales al inicio del ictus
    19. Sujetos con enfermedad neurológica o psiquiátrica preexistente que podría confundir las evaluaciones neurológicas o funcionales; la puntuación basal mRS (escala Rankin) debe ser < 2. Esto excluye a los pacientes que viven en un hogar de ancianos o que no son totalmente independientes para realizar las actividades diarias cotidianas (higienizarse, vestirse, comer, cocinar y preparar comidas, etc.)
    20. Otras enfermedades graves, avanzadas o terminales
    21. Cualquier otra condición que el investigador crea que representaría un peligro considerable para el sujeto en caso de iniciarse un tratamiento con Activase®/Actilyse® (Alteplasa)
    22. Participación actual en otro protocolo para tratamiento con un fármaco en estudio
    23. No se obtiene o no se puede obtener el consentimiento informado escrito de conformidad con los requisitos regulatorios regionales
    24. Lesión de alta densidad consistente con hemorragia de cualquier grado
    25. Efecto de masa significativo con desplazamiento de la línea media
    26. Vastas áreas (>1/3 de la arteria cerebral media) de hipodensidad clara en la tomografía computarizada inicial. (ASPECTOS de < 4 pueden usarse como guía). El borramiento de surcos o la pérdida de la diferenciación entre materia gris y blanca no son contraindicaciones para el tratamiento
    27. Evidencia en la tomografía computarizada de tumor intraparenquimatoso
    E.5 End points
    E.5.1Primary end point(s)
    El indicador principal del resultado en este estudio es un resultado favorable en términos de independencia funcional, según la puntuación obtenida por la medición de la Escala Rankin modificada de 0-2 a los 3 meses.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    igualar Medicamento
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    la última visita del último sujeto incluido en el ensayo
    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 years5
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-01-21. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    El paciente que sufre de ictus puede estar incapaz de frmar el consentimiento informado. Los procedimientos estarán de acuerdo con las normativas aprobadas por el Comité Etico (obtención del CI por representante).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 900
    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 del estudio clínico podrán ser tratados con todos los medicamentos que sean necesarios durante situaciones de ictus rutinaria
    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 Decision2011-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-08
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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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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