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    Summary
    EudraCT Number:2012-000791-42
    Sponsor's Protocol Code Number:JVM-GLU-12
    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:2012-05-29
    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 number2012-000791-42
    A.3Full title of the trial
    OPEN, RANDOMIZED AND CONTROLLED STUDY OF SAFETY AND VIABILITY, TO EVALUATE THE NEUROPROTECTIVE EFFECT OF PLASMA GLUTAMATE DIALYSIS IN ACUTE ISCHEMIC STROKE.
    ESTUDIO DE VIABILIDAD Y SEGURIDAD, ABIERTO, ALEATORIZADO Y CONTROLADO, PARA EVALUAR EL EFECTO NEUROPROTECTOR DE LA DIÁLISIS DE GLUTAMATO PLASMÁTICO EN LA FASE AGUDA DEL INFARTO CEREBRAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF SAFETY AND VIABILITY TO EVALUATE THE POTENTIAL NEUROPROTECTIVE EFFECT OF PERITONEAL DYALISIS IN THE STROKE
    ESTUDIO DE SEGURIDAD Y VIABILIDAD PARA VALORAR EL POTENCIAL EFECTO NEUROPROTECTOR DE LA DIÁLISIS PERITONEAL EN EL INFARTO CEREBRAL
    A.3.2Name or abbreviated title of the trial where available
    SAFETY OF PERITONEAL DYALISIS IN STROKE
    SEGURIDAD DE LA DIALISIS PERITONEAL EN EL INFARTO CEREBRAL AGUDO
    A.4.1Sponsor's protocol code numberJVM-GLU-12
    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 SponsorFUNDACION INVESTIGACION BIOMEDICA HOSPITAL UNIVERSITARIO LA PRINCESA
    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 supportFUNDACION INVESTIGACION SANITARIA, HOSPITAL LA PRINCESA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION INVESTIGACION BIOMEDICA
    B.5.2Functional name of contact pointMONICA SOBRADO
    B.5.3 Address:
    B.5.3.1Street AddressDIEGO DE LEON 62
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+34915202416
    B.5.5Fax number+34915202416
    B.5.6E-mailsobrado.m@med.ucm.es
    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 PHYSIONEAL 35 GLUCOSE 1,36% P/V (DYALISIS PERITONEAL SOLUTION).
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER
    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.3.1Product namePhysioneal 35 Solution for Peritoneal Dialysis
    D.3.2Product code B05DB00
    D.3.4Pharmaceutical form Solution for peritoneal dialysis
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 01/10/5996
    D.3.9.3Other descriptive nameGLUCOSE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB13983MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.67
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 10035-04-8
    D.3.9.3Other descriptive nameCALCIUM CHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.257
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.051
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 144-55-8
    D.3.9.3Other descriptive nameSODIUM BICARBONATE
    D.3.9.4EV Substance CodeSUB12643MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameSODIUM LACTATE SOLUTION
    D.3.9.4EV Substance CodeSUB12297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namephosphate monosodium
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    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
    BRAIN ISCHEMIC STROKE IN ACUTE PHASE
    INFARTO CEREBRAL ISQUÉMICO EN FASE AGUDA
    E.1.1.1Medical condition in easily understood language
    BRAIN STROKE
    INFARTO CEREBRAL O ICTUS
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    To establish the viability and safety of this clinical-stage study in patients with cerebral infarction who underwent a peritoneal dialysis procedure in the acute phase (a conventional dialysis fluid enriched with phosphate will be used). This study is established as a preliminary step for a more extensive clinical trial that has as main objective efficacy parameters.
    Establecer la viabilidad y seguridad de este estudio en su fase clínica en pacientes con un infarto cerebral a los que se les realizará un procedimiento de diálisis peritoneal en la fase aguda (se utilizará un líquido de diálisis convencional enriquecido con fosfato). Se establece este estudio como etapa preliminar para un ensayo clínico de mayor extensión que tenga como objetivo principal parámetros de eficacia.
    E.2.2Secondary objectives of the trial
    To determine the potential efficacy and clinical benefit as estimated by infarct volume, mortality and functional status of patients at 90 days by applying mRS scale.

    To research the evolution of Glu levels in serum and peritoneal dialysis in patients with cerebral infarction in the acute phase.
    Determinar el beneficio clínico estimado por el volumen del infarto, la mortalidad y situación funcional de los pacientes a los 90 días, mediante la aplicación escala modificada de Rankin (mRS)

    Investigar la evolución los niveles de glutamato, en suero y dializado peritoneal, en pacientes con infarto cerebral en la fase aguda
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients 18 to 80 years-old with acute ischemic stroke in the territory of the middle cerebral artery, which can not be applied pharmacological thrombolysis or mechanical thrombectomy, with less than 12h duration and have given consent.
    pacientes de 18 a 80 años con ictus isquémico agudo del territorio de la arteria cerebral media, en los que no se pueda aplicar tratamiento trombolítico farmacológico o trombectomía mecánica, de menos de 12 h de evolución y que hayan otorgado su consentimiento.
    E.4Principal exclusion criteria
    -Patients with previous functional dependency (mRS>2),
    -presence of minor neurological deficit (NIHSS scale < 4 at the time of randomization) or rapid improvement during the process of inclusion,
    -very severe neurological deficit (NIHSS>20),
    -state of coma,
    - posterior territory stroke;
    - lacunar stroke with symptoms (pure hemiparesis, pure hemihypoestesia, dysarthria, clumsy hand, ataxia, hemiparesis),
    -haematological diseases, infectious, inflammatory or neoplastic known at the time of treatment,
    -pregnancy or lactation (urine analysis be performed prior to randomization in women of childbearing age),
    -renal impairment (CLcr < 40 ml/h o Creat > 1.5 mg/dl) previously known;
    - severe liver disease, any comorbility status at the discretion of the investigator may prevent the patient complete the study;
    -hours of stroke onset unknown (in stroke upon awakening is taken as the start time of the last time the patient was seen asymptomatic);
    -contraindication to standard procedure of peritoneal dialysis,
    -haemorrhagic stroke in the imaging scan performed at baseline,
    -stroke or myocardial infarction within the previous 90days,
    -platelet count<100.000/mm3,
    -treatment with anticoagulants
    - INR < 1.4 or Time cephalin > 1.3 times the control group,
    -participation in another clinical trial within the previous 90 days.
    -Pacientes con dependencia funcional previa (mRS>2);
    -presencia de un déficit neurológico menor (escala NIHSS<4 en el momento de la aleatorización) o rápida mejoría durante el proceso de inclusión;
    -déficit neurológico muy grave (NIHSS>20),
    -estado de coma;
    - ictus de territorio posterior ;
    -ictus con sintomatología lacunar (hemiparesia pura, hemihipoestesia pura, hemiparesia hemihipoestesia, disartria mano torpe, ataxia hemiparesia);
    -enfermedades hematológicas, infecciosas, inflamatorias o neoplásicas conocidas en el momento del tratamiento;
    -embarazo o lactancia (se realizará análisis en orina previo a la aleatorización en mujeres en edad fértil);
    - insuficiencia renal (Clcr < 40 ml/h o Creat > 1,5 mg/dl) previa conocida;
    enfermedad hepática grave;
    - cualquier situación de comorbilidad que a criterio del investigador pueda impedir que el paciente complete el estudio;
    - hora de comienzo del ictus desconocida (en el ictus al despertar se tomará como hora de inicio la de la última vez que el paciente fue visto asintomático);
    - contraindicación para realizar un procedimiento estándar de diálisis peritoneal;
    - ictus hemorrágico en la prueba de neuroimagen realizada al inicio;
    - ictus o infarto de miocardio en los 90 días previos;
    - recuento plaquetar <100.000/mm3;
    - tratamiento con anticoagulantes
    - INR > 1,4 ó Tiempo de cefalina > 1,3 veces el control;
    - participación en otro ensayo clínico en los 90 días previos.
    E.5 End points
    E.5.1Primary end point(s)
    SAFETY AND VIABILITY
    SEGURIDAD Y VIABILIDAD
    E.5.1.1Timepoint(s) of evaluation of this end point
    CLINICAL PRESENCE OF SIDE EFFECTS (HYPOTENSION, CARDIOVASCULAR AND HEMODYNAMIC, DIGESTIVE, ABDOMINAL-SPECIAL WATCH OR INCIDENTS OF BLEEDING-VISCERA PERFORATION, INFECTION, NEUROLOGICAL DETERIORATION DUE TO INTRACRANIAL HYPERTENSION OR HEMORRHAGIC TRANSFORMATION.


    ANALYTICAL CONTROLS OF HEMATOCRIT, HEMOGLOBIN, LEUKOCYTES, ESR, PLATELETS, FIBRINOGEN, T.QUICK, APTT, ION, BLOOD GLUCOSE, LIVER FUNCTION AND RENAL FUNCTION AT BASELINE AND 24 AND 72H AND 7 DAYS.


    VOLUME OF HYPODENSITY, HEMORRHAGIC TRANSFORMATION ON CT 24H AND 72H, EARLY NEUROLOGICAL DETERIORATION (INCREASE OF 4 OR MORE POINTS IN THE NIHSS SCALE FOR THE FIRST 24H) AND MORTALITY TO 3 MONTHS.


    MEDICAL COMPLICATIONS AND SERIOUS ADVERSE EVENTS
    PRESENCIA DE EFECTOS ADVERSOS CLÍNICOS (HIPOTENSIÓN, COMPLICACIONES CARDIOVASCULARES Y HEMODINÁMICAS, DIGESTIVAS, ABDOMINALES -ESPECIAL VIGILANCIA DE INCIDENCIAS DE SANGRADO O PERFORACIÓN DE VÍSCERA HUECA-, INFECCIONES, DETERIORO NEUROLÓGICO POR HIPERTENSIÓN INTRACRANEAL O TRANSFORMACIÓN HEMORRÁGICA SINTOMÁTICA.

    CONTROLES ANALÍTICOS SERIADOS DE HEMATOCRITO, HEMOGLOBINA, LEUCOCITOS, VSG, PLAQUETAS, FIBRINÓGENO, T.QUICK, TTPA, IONES, GLUCEMIA, FUNCIÓN HEPÁTICA Y FUNCIÓN RENAL BASALES Y A LAS 24 Y 72H Y 7 DÍAS.

    VOLUMEN DE HIPODENSIDAD, LA TRANSFORMACIÓN HEMORRÁGICA EN LA TC A 24H Y 72H, EL DETERIORO NEUROLÓGICO PRECOZ (INCREMENTO DE 4 O MÁS PUNTOS EN LA ESCALA NIHSS DURANTE LAS PRIMERAS 24H) Y LA MORTALIDAD A 3 MESES.

    COMPLICACIONES MÉDICAS Y ACONTECIMIENTOS ADVERSOS GRAVES
    E.5.2Secondary end point(s)
    efficacy (potential efficacy and clinical benefit)
    EFICACIA (EFICACIA POTENCIAL Y BENEFICIO CLÍNICO)
    E.5.2.1Timepoint(s) of evaluation of this end point
    THE POTENTIAL EFFICACY AND CLINICAL BENEFIT WILL BE ESTIMATED A) QUANTIFYING THE VOLUME OF INFARCTED TISSUE (CONSIDER A REDUCTION IN INFARCTED TISSUE 20% VS CONTROL) AND B) NEUROLOGICAL STATUS-A FAVORABLE OUTCOME IN NEUROLOGICAL DEFICIT (NIHSS 0.1 OR IMPROVEMENT ? 10 POINTS) AND FUNCTIONAL STATUS (MODIFIED RANKIN SCALE (MRS) ? 2, ASSESSED WITH STRUCTURED INTERVIEW) TO 7 DAYS, OR AT THE TIME OF HIGH IF BEFORE, AND 3 MONTHS.

    DETERMINATION OF THE CONCENTRATION OF GLUTAMATE IN THE SERUM AND LIQUID DIALYSATE OF PATIENTS AND THEIR CORRELATION WITH INFARCT SIZE AND NEUROLOGICAL DEFICITS.
    LA EFICACIA POTENCIAL Y BENEFICIO CLÍNICO SE ESTIMARÁN A) CUANTIFICANDO EL VOLUMEN DE TEJIDO INFARTADO (ESTIMAMOS UNA REDUCCIÓN DEL TEJIDO INFARTADO EN UN 20% VS CONTROL) Y B) EL STATUS NEUROLÓGICO -UNA EVOLUCIÓN FAVORABLE EN EL DÉFICIT NEUROLÓGICO (NIHSS 0,1 O MEJORÍA ? 10 PUNTOS) Y EN EL ESTADO FUNCIONAL (ESCALA MODIFICADA DE RANKIN (MRS) ? 2, EVALUADA CON UNA ENTREVISTA ESTRUCTURADA) A LOS 7 DÍAS, O EN EL MOMENTO DEL ALTA SI ES ANTES, Y A LOS 3 MESES-.

    DETERMINACIÓN DE LA CONCENTRACIÓN DE GLUTAMATO EN EL SUERO Y LÍQUIDO DE DIALIZADO DE LOS PACIENTES Y SU CORRELACIÓN CON EL TAMAÑO DEL INFARTO Y LOS DÉFICITS NEUROLÓGICOS.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    PACIENTES CON ICTUS SOMETIDOS A TRATAMIENTO CONVENCIONAL EN UNA UNIDAD DE ICTUS
    PATIENTS WITH ACUTE ISCHEMIC STROKE SUBJECTED TO CONVENTIONAL TREATMENT IN AN STROKE UNIT
    E.8.2.4Number of treatment arms in the trial1
    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 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
    ON WHICH THE LAST SUBJECT COMPLETED THE STUDY FOLLOW-UP VISITBJECT COMPLETED
    FECHA EN LA QUE EL ÚLTIMO SUJETO COMPLETA LA VISITA DE SEGUIMIENTO DEL ESTUDIO
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    if the patient is incapable of giving consent, the patient may give consent verbally or gesture to a tutor or legal representative in order to participate in the study
    si el pacientes es incapaz de dar su consentimiento, el paciente podrá otorgar su consentimiento de forma verbal o gestual a un tutor o representante legal para así poder participar en el estudio
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    WE MUST MAKE A VISIT IN PERSON AT THE HOSPITAL AT 90 DAYS IN ALL PATIENTS IN THE CLINICAL TRIAL, DESIGNED TO SHOW SAFETY AND EFFICACY VARIABLES PREDETERMINED.

    SUBSEQUENTLY, THE PATIENT COMPLETES THE STUDY AND FOLLOW THE USUAL PROTOCOL FOR MONITORING PATIENTS WITH STROKE (NEUROLOGY, PRIMARY CARE OR BOTH)
    HAY QUE HACER UNA VISITA PRESENCIAL EN EL HOSPITAL A LOS 90 DÍAS A TODOS LOS PACIENTES INCLUIDOS EN EL ENSAYO, DONDE SE RECOGEN VARIABLES DE SEGURIDAD Y EFICACIA PREESTABLECIDAS.

    POSTERIORMENTE, EL PACIENTE TERMINA EL ESTUDIO Y SEGUIRÁ EL PROTOOCLO HABITUAL DE SEGUIMIENTO DE LOS PACIENTES CON INFARTO CEREBRAL (NEUROLOGÍA, ATENCIÓN PRIMARIA O AMBOS).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
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