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    Summary
    EudraCT Number:2012-003895-38
    Sponsor's Protocol Code Number:D5134C00001
    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:2014-01-10
    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 number2012-003895-38
    A.3Full title of the trial
    A randomised, double-blind, multinational study to prevent major vascular events with Ticagrelor compared to Aspirin(ASA) in patients with acute ischaemic stroke or Transient Ischemic Attack (TIA). [SOCRATES - Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patients OutcomeS].
    Ensayo aleatorizado, doble ciego, multinacional, para la prevención de episodios vasculares mayores con ticagrelor comparado con aspirina (AAS) en pacientes con infarto cerebral agudo o AIT. [SOCRATES: Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to prevent major vascular events with Ticagrelor compared to Aspirin in patients with Acute Ischaemic Stroke or TIA
    Estudio para la prevención de episodios vasculares mayores con ticagrelor comparado con aspirina en pacientes con ictus isquémico agudo o AIT
    A.3.2Name or abbreviated title of the trial where available
    SOCRATES
    SOCRATES
    A.4.1Sponsor's protocol code numberD5134C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Roble
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 Yes
    D.2.1.1.1Trade name BRILIQUE
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTicagrelor
    D.3.4Pharmaceutical form Film-coated 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 INNticagrelor
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeAZD6140
    D.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 ASPIRIN protect
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAspirin protect tablets 100mg
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor codeACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    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) 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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ischaemic stroke
    ictus isquémico
    E.1.1.1Medical condition in easily understood language
    Brain damage caused by deprivation of blood.
    Daño cerebral causado por falta de riego sanguíneo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000004852
    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 objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs. acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).
    El objetivo principal del ensayo es comparar el efecto de 90 días de tratamiento con ticagrelor (dosis de carga de 180 mg [dos comprimidos de 90 mg] el Día 1, seguida de una dosis de mantenimiento de 90 mg dos veces al día durante el resto del ensayo) con el de aspirinaTM (ácido acetilsalicílico, AAS) (una dosis de carga de 300 mg [tres comprimidos de 100 mg] el Día 1 seguida de una dosis de mantenimiento de 100 mg una vez al día durante el resto del ensayo) para la prevención de episodios vasculares mayores (compuesto de ictus, IM y muerte) en pacientes con ictus isquémico agudo o AIT.
    E.2.2Secondary objectives of the trial
    Compare the effects of treatment with ticagrelor vs. ASA
    on:
    1) prevention of subsequent ischaemic stroke.
    2) net clinical outcome (stroke + MI + death + life threatening bleeding).
    3) prevention of composite of ischaemic stroke, MI and cardiovascular [CV] death.
    4) prevention of all-cause death, CV death and MI, individually
    5) severity of stroke and overall disability of patients using modified Rankin Scale
    6) prevention of all stroke (including haemorrhagic stroke), fatal stroke and disabling stroke, individually.
    7) health care resource and utilities assessed by Euro Quality of Life-5 Dimensions to support health technology assessment and health economic modelling.
    comparar los efectos del tratamiento con ticagrelor con los del AAS en cuanto a:
    1)Prevención de ictus isquémico posterior
    2)Resultado clínico neto (ictus + IM + muerte + hemorragia potencialmente mortal)
    3)Prevención individualmente de la mortalidad por cualquier causa, la mortalidad cardiovascular y el IM, individualmente
    4)Prevención individualmente de la mortalidad por cualquier causa, la mortalidad cardiovascular y el IM, individualmente
    5)Severidad del ictus y discapacidad general de los pacientes evaluada mediante la Escala de Rankin modificada
    6)Prevención individualmente de todos los ictus (incluido el ictus hemorrágico), ictus mortal e ictus incapacitante, individualmente
    7)Tasa de empeoramiento, es decir, progresión del ictus inicial (evento índice), evaluada mediante el empeoramiento de los síntomas clínicos y/o por un aumento en la puntuación en la Escala NIH del ictus
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men or women equal or elder 40 years of age - Either acute ischaemic stroke not eligible for thrombolysis or mechanical thrombectomy or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms.
    Hombres o mujeres de 40 años o menores con ictus isquémico agudo no elegible para trombolisis o trombectomía mecánica, o AIT de alto riesgo como se define a continuación y ser aleatorizado en las 24 horas siguientes al inicio de los síntomas
    E.4Principal exclusion criteria
    Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins). - Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke. - Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation. - Receipt of any intravenous or intra-arterial thrombolysis
    or mechanical thrombectomy within 24 hours prior to randomisation - History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days.
    Se prevé el uso de tratamiento antitrombótico añadido a la medicación del ensayo, como los antiagregantes (p. ej., AAS sin enmascarar, inhibidores de GPIIb/IIIa, clopidogrel, ticlopidina, prasugrel, dipiridamol, ozagrel, cilostazol) y los anticoagulantes (p. ej., warfarina, inhibidores orales de la trombina y del factor Xa, bivalirudina, hirudina, argatrobán, heparinas no fraccionadas y de bajo peso molecular)
    Algún antecedente de fibrilación auricular, aneurisma ventricular o sospecha de patología cardioembólica como causa del AIT o ictus
    Revascularización carotídea, cerebrovascular o coronaria programada que exija suspender la medicación del ensayo en los 7 primeros días después de la aleatorización
    Haber recibido cualquier forma de trombólisis intravenosa o intrarterial o trombectomía mecánica en las 24 horas previas a la aleatorización
    Antecedentes de hemorragia intracerebral no traumática, sintomática, en algún momento anterior (no cuentan las microhemorragias asintomáticas), hemorragia gastrointestinal (GI) en los últimos 6 meses o cirugía mayor en los 30 días previos
    E.5 End points
    E.5.1Primary end point(s)
    Composite of stroke, MI and death.
    compuesto de ictus, IM y muerte
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization for 2.5 year (min.treatment duration)
    Desde la aleatorización hasta 2.5 años (duración mínima del tratamiento)
    E.5.2Secondary end point(s)
    Composite of ischaemic stroke, MI and CV death.
    Net clinical outcome.
    Time to discontinuation of study medication due to any bleeding event.
    Compuesto de ictus, IM y muerte CV
    Resultado clínico neto
    Tiempo de interrupción de la medicación del estudio debido a un acontecimiento hemorrágico
    E.5.2.1Timepoint(s) of evaluation of this end point
    From randomization for 2.5 year (min.treatment duration)
    Desde la aleatorización hasta 2.5 años (duración mínima del tratamiento)
    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 Yes
    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) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA165
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    China
    France
    Italy
    Japan
    Romania
    Slovakia
    Sweden
    Argentina
    Australia
    Brazil
    Chile
    Czech Republic
    Germany
    Hong Kong
    Korea, Republic of
    Spain
    Thailand
    Mexico
    Peru
    Philippines
    Poland
    Russian Federation
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United States
    Vietnam
    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
    LVLS
    La última visita del último sujeto que participe 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 years3
    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: 6800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2800
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3060
    F.4.2.2In the whole clinical trial 9600
    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)
    standard of care
    Tratamiento habitual
    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 Decision2014-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-02
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