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    Summary
    EudraCT Number:2017-002760-41
    Sponsor's Protocol Code Number:CL2-RTCCAR-001
    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:2017-08-10
    Trial results View 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 number2017-002760-41
    A.3Full title of the trial
    Assessment of Active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) plasma kinetics in Patients at acute stage of Ischemic Stroke: Prospective, Multicentre, Open, Non-randomised, Biomarker Study
    Evaluación de la cinética plasmática del inhibidor activo de la fibrinolisis activable por trombina (TAFIa) en pacientes con ictus isquémico en fase aguda: Estudio prospectivo de biomarcadores, multicéntrico, abierto, no aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of blood concentration of an enzyme named Active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) in Patients at acute stage of Stroke
    Evaluación de la concentración en la sangre de una enzima llamada inhibidor activo de la fibrinólisis activable por trombina (TAFIa) en pacientes con ictus isquémico en fase aguda
    A.3.2Name or abbreviated title of the trial where available
    TAFIa levels in Acute Stroke
    NIveles de TAFIa en ictus agudo
    A.4.1Sponsor's protocol code numberCL2-RTCCAR-001
    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 Sponsorinstitute de Recherches Internacionales Servier (promotor internacional)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratorios Servier S.L. (promotor local)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier S.L
    B.5.2Functional name of contact pointDpto. de Investigacion y Desarrollo
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Madroños 33
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917489014
    B.5.5Fax number+34913003249
    B.5.6E-mailitziar.fernandezgonzalez@servier.com
    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 No
    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 nameNA
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number 123
    D.3.9.2Current sponsor code123
    D.3.9.3Other descriptive nameHYDROCHLORIC ACID, CONCENTRATED
    D.3.9.4EV Substance CodeSUB12050MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Ischemic Stroke
    Ictus Isquémico Agudo
    E.1.1.1Medical condition in easily understood language
    Stroke
    Ictus
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000013700
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary exploratory objective is to assess the systemic plasma kinetics of the active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) during the acute stage of ischemic stroke in patients eligible for recombinant tissue Plasminogen Activator (rtPA) thrombolysis alone or rtPA thrombolysis followed by endovascular thrombectomy (EVT).
    El objetivo exploratorio principal es evaluar la cinética plasmática sistémica del inhibidor activo de la fibrinolisis activable por trombina (TAFIa) durante la fase aguda de un ictus isquémico en pacientes que cumplen los requisitos para someterse a una trombolisis con activador tisular del plasminógeno recombinante (rtPA) solo o trombolisis con rtPA seguida de trombectomía endovascular (ETV).
    E.2.2Secondary objectives of the trial
    Other exploratory objectives are:
    - To assess systemic TAFIa levels according to cerebral arteries occlusion site in anterior circulation (proximal or distal artery),
    - To assess systemic TAFIa levels in ischemic stroke patients treated by rtPA thrombolysis ± EVT,
    - To assess TAFIa levels according to the stroke clinical severity (National Institute of Health Stroke Score (NIHSS)) at baseline and 24h,
    - To assess tissue plasminogen activator (tPA) plasma kinetic during acute stage of ischemic stroke in patients eligible for rtPA-thrombolysis alone or followed by EVT,
    - To assess several haemostasis parameters according to systemic TAFIa levels,
    - To assess in situ peri-thrombus TAFIa level in EVT eligible patients via blood sampling collected upstream to proximal part of the thrombus through intra-arterial catheter used for EVT,
    - To assess TAFIa levels according to the characteristics of the clot retrieved during EVT (clot composition, clot weight).
    Otros objetivos exploratorios son:
    -Evaluar niveles TAFIa sistémicos de acuerdo con el lugar de oclusión de las arterias cerebrales en la circulación anterior (arteria proximal o distal)
    -Evaluar niveles TAFIa sistémicos en pacientes con ictus isquémico tratados con trombolisis con rtPA ± ETV
    -Evaluar niveles TAFIa de acuerdo con la gravedad clínica del ictus (NIHSS) en la visita inicial y a las 24 h
    -Evaluar cinética plasmática del tPA durante la fase aguda del ictus isquémico en pctes que cumplen requisitos para someterse a trombolisis con rtPA sola o seguida de ETV.
    -Evaluar varios parámetros de hemostasis de acuerdo con los niveles sistémicos de TAFIa.
    -Evaluar nivel de TAFIa peritrombo in situ en pctes que cumplen los requisitos para someterse a ETV en muestras de sangre recogidas antes de la parte proximal del trombo mediante un catéter intraarterial usado para ETV.
    -Evaluar niveles de TAFIa de acuerdo con las características del coágulo recuperado durante la ETV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (≥ 18 years old) within 4.5 hours after ischemic stroke symptoms onset (or last time known normal),
    - Imaging evidence of cerebral artery occlusion in anterior circulation: proximal (internal carotid artery (ICA), middle cerebral artery M1 (MCA-M1) or distal (MCA-M2, MCA-M3) arteries,
    - Eligible for pharmacological thrombolysis alone or followed by EVT according to current clinical guidelines,
    - Complete informed consent signed (by the patient or an authorized representative according to local regulation) prior to participation in the trial or within 12 hours if an abbreviated informed consent has been signed prior to the participation in the trial (by the patient or an authorized representative according to local regulation) or orally agreed by the patient and witnessed by a person according to local regulation.
    - Pacientes adultos (≥ 18 años) dentro de las 4,5 horas posteriores al comienzo de los síntomas del ictus isquémico (o al último momento conocido en el que estaba normal elpaciente),
    - Evidencia por imagen de la oclusión de una arteria cerebral en la circulación anterior: proximal (arteria carótida interna (ICA), arteria cerebral media M1 (MCA-M1) o arteria distal (MCA-M2, MCA-M3),
    - Candidato a trombolisis farmacológica sola o seguida de ETV según las guías de práctica clínica actuales,
    - Consentimiento informado completo firmado (por un paciente o un representante autorizado según la normativa local) antes de la entrada en el estudio o en el plazo de las 12 horas siguientes en el caso de que un consentimiento informado abreviado haya sido firmado antes de la entrada en el estudio (por un paciente o un representante autorizado según la normativa local) o verbalmente acordado por el paciente y presenciado por una persona según la normativa local,
    E.4Principal exclusion criteria
    - Any known serious disease (including active malignancy, active infection) likely to interfere with the conduct of the study, according to investigator’s judgment,
    - Known pregnant or breastfeeding woman,
    - Patients unlikely to cooperate in the study,
    - Participation in another interventional study at the same time or within the past 3 months (participation in non-interventional registries or epidemiological studies is allowed).
    - Enfermedad grave conocida (incluyendo malignidad activa, infección activa) que pueda interferir con la realización del estudio, según el criterio del investigador,
    - Embarazo conocido o mujer en periodo de lactancia,
    - Pacientes cuya cooperación en el estudio se considera poco probable,
    - Participación en otro estudio de intervención al mismo tiempo o en los últimos 3 meses (se permite la participación en registros de no intervención o estudios epidemiológicos).
    E.5 End points
    E.5.1Primary end point(s)
    Biomarker TAFIa: Systemic TAFIa plasma level assessment in patients receiving rtPA treatment (group A) or rtPA + EVT treatment (group B).
    Biomarcador TAFIa: Mediciones niveles plasmáticos de TAFIa en pacientes tratados con rtPA (grupo A) o trPA +ETV (grupo B)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Groups A and B: intravenous blood samples over 24h after rtPA administration
    - Group B only: one arterial blood sample through the EVT catheter immediately before first pass
    Grupos A y B: muestras de sangre intravenosa en las 24 horas tras la administración de rtPA.
    Solo grupo B: una muestra de sangre arterial a través del catéter ETV justo antes del primer pase.
    E.5.2Secondary end point(s)
    - Biomarker tPA: tPA kinetic measurements in groups A and B
    - Hemostasis parameters: D-Dimers, Fibrinogen, Fibrin Degradation Products, plasminogen, plasmin-anti-plasmin complexes assessment in groups A and B
    - Main clinical assessment and collected data
    Groups A and B: NIHSS score assessment, imaging thrombus characteristics and infarct volume, etiology of the stroke according to TOAST classification, early ischemic change in Middle Cerebral Artery territory and platelet count
    Group B only if performed in the hospital common practice, collection of thrombolysis in Cerebral Infarction (TICI) score and characteristics of the clot retrieved during EVT.
    - Safety measurements: all adverse events and other situations relevant to the safety of the participants
    Biomarcador tPA: mediciones cinéticas en los grupos A y B
    -Parámetros de hemostasia: D-dimeros, fibrinógeno, productos de degradación de la fibrina, plasminogeno, evaluación complejos plasmina-anti-plasmina en los grupos A y B
    Principal evaluación clínica y datos recopilados:
    Evaluación de la puntuación NIHSS en la visita inicial y a las 24 h, características de imagen del trombo y volumen del infarto, etiología del ictus acorde a la clasificación TOAST , cambio isquémico precoz en la región de la arteria cerebral media y recuento de plaquetas.
    En el grupo B solo si se realiza en la práctica habitual del hospital :Puntuación de Trombolisis en Infarto Cerebral (TICI) y características del coágulo recuperado durante la ETV
    Evaluaciones de seguridad:todos los acontecimientos adversos y otras situaciones relevantes para la seguridad de los participantes
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Biomarker tPA: IV blood samples over 24h after rtPA administration
    - Hemostasis parameters: IV blood samples over 24h after rtPA administration
    - Main clinical assessment and collected data:
    NIHSS score assessment at baseline and at 24h, imaging thrombus characteristics and infarct volume at inclusion and 24±4h, etiology of the stroke according to TOAST classification, early ischemic change in Middle Cerebral Artery territory and platelet count at baseline.
    TICI score at baseline (before thrombolysis), after EVT in case of follow-up imaging and at 24 ± 4 hours.
    Characteristics of the clot: after EVT
    - Safety measurements: all over the study
    Biomarcador tPA y parámetros de hemostasia: muestras de sangre IV en las 24 horas tras la administración de rtPA..
    Principal evaluación clínica y datos recopilados:
    Evaluación de la puntuación NIHSS en la visita de inicio y a las 24 h., características de imagen del trombo y volumen del infarto,en la visita de inicio y a las 24 h.±4h, etiología del ictus acorde a la clasificación TOAST , cambio isquémico precoz en la región de la arteria cerebral media y recuento de plaquetas en la visita de inicio.
    Puntuación TICI en la visita de inicio (antes de ETV)y después de ETV si seguimeinto por imagen a 24h±4h y características del coágulo después de la ETV
    Evaluaciones de seguridad: a lo largo de todo el estudio
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker study
    Estudio de biomarcadors
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA7
    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 No
    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
    End of Trial is defined as the date of the P001 (up to 28h) of the last participant, or the date of the last contact attempt if the last patient is declared lost to follow-up.
    El fin del estudio se define como la fecha de P001 (hasta 28 horas) del ultimo participante, o la fecha del ultimo intento de contacto si el paciente está declarado como perdido de vista.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 2017-08-10. 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
    Patients included in this study are at acute stage of ischemic s troke and can therefore be in aphasia or unconscious. In this case, the investigator or a person designated by him/her is to collect written consent from an authorized representative.
    Son pacientes con ictus isquémico en fase aguda que pueden estar afásicos o incosncientes. En este caso el IP ó persona designada por él recogerá el CI por escrito de un representante legal o persona con relación familiar o de hecho con el paciente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    No investigational medicinal product will be provided to the patients. The patients will receive the standard-of-care treatment, including rtPA thrombolysis or rtPA and EVT if indicated according to current clinical guidelines.
    No se dará ningún medicamento en investigación a los pacientes. Los pacientes serán tratados con los estándares de la práctica clínica, incluyendo trombolisis con rtPA o rtPA y EVT si está indicando según las guías clínicas actuales.
    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 Decision2017-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-05
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