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    The EU Clinical Trials Register currently displays   35512   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-003519-23
    Sponsor's Protocol Code Number:D513BC00001
    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
    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 number2013-003519-23
    A.3Full title of the trial
    A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus.
    Ensayo multinacional, aleatorizado, doble ciego, controlado con placebo, para evaluar el efecto de ticagrelor 90 mg dos veces al día sobre la incidencia de muerte cardiovascular, infarto de miocardio o ictus en pacientes con diabetes mellitus tipo 2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing Cardiovascular Effects of Ticagrelor versus Placebo in Patients with Type 2 Diabetes Mellitus.
    Estudio que compara los efectos cardiovasculares de Ticagrelor en comparación con Placebo en pacientes con diabetes mellitus tipo 2.
    A.3.2Name or abbreviated title of the trial where available
    THEMIS - effect of Ticagrelor on Health outcomes in diabEtes Mellitus patients Intervention Study
    THEMIS-Estudio intervención ticagrelor sobre resultados de salud en pacientes con diabetes mellitus
    A.4.1Sponsor's protocol code numberD513BC00001
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1149-3152
    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, Ed. 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 90mg film-coated tablets
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    major cardiovascular events in type 2 diabetes mellitus patients
    Acontecimientos Cardiovasculares mayores en pacientes con diabetes mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    cardiovascular death, myocardial infarction and stroke
    muerte cardiovascular, infarto de miocardio o ictus
    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 10042244
    E.1.2Term Stroke
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 long-term treatment with ticagrelor 90 mg twice daily (bd) vs. placebo for the prevention of major cardiovascular (CV) events (composite of CV death, myocardial infarction [MI] or stroke) in patients with Type 2 Diabetes Mellitus (T2DM) at high risk for CV events, but without a previous medical history of MI or stroke.
    The primary efficacy variable is time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke (ischaemic, haemorrhagic or unknown etiology).
    El objetivo principal del ensayo es comparar el efecto del tratamiento a largo plazo con ticagrelor 90 mg administrado dos veces al día (BID) en comparación con placebo para la prevención de los acontecimientos cardiovasculares (CV) mayores (combinación de muerte CV, infarto de miocardio [IM] o ictus) en pacientes con diabetes mellitus tipo 2 (DMT2) con alto riesgo de sufrir acontecimientos CV, pero sin antecedentes médicos de IM o ictus previos.
    La variable principal de eficacia es el tiempo transcurrido desde la aleatorización hasta que ocurra por primera vez algún episodio de la combinación de muerte CV, IM o ictus (de etiología isquémica, hemorrágica o desconocida).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study (presented in hierarchical order) are to compare the effect of long-term treatment with ticagrelor vs. placebo for:
    1. Prevention of the composite of all-cause death, MI or stroke. The efficacy variable is time from randomisation to first occurrence of any event from the composite of all-cause death, MI or stroke.
    2. Prevention of CV death. The efficacy variable is time from randomisation to death of CV cause.
    3. Prevention of all-cause death. The efficacy variable is time from randomisation to death of any cause.
    Los objetivos secundarios del ensayo (presentados en orden jerárquico) son comparar el efecto del tratamiento a largo plazo con ticagrelor frente a placebo para:
    1. La prevención de la combinación de muerte por cualquier causa, IM o ictus. La variable de eficacia es el tiempo transcurrido desde la aleatorización hasta que ocurra por primera vez cualquier episodio del criterio de valoración compuesto de muerte por cualquier causa, IM o ictus.
    2. La prevención de la muerte CV. La variable de eficacia es el tiempo transcurrido desde la aleatorización hasta la muerte por causas CV.
    3. La prevención de la muerte por cualquier causa. La variable de eficacia es el tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men or women > or = 50 years of age
    Diagnosed with T2DM defined by ongoing glucose lowering drug treatment prescribed by a physician for treatment of T2DM since at least 6 months prior to Visit 1
    At high risk of CV events, defined as history of percutaneous coronary intervention or coronary artery bypass graft or angiographic evidence of > or = 50% lumen stenosis of at least 1 coronary artery
    Hombres o mujeres > ó = 50 años.
    Diagnóstico de DMT2, definida por el uso actual de un tratamiento farmacológico para la diminución de los niveles de glucosa recetado por un médico para el tratamiento de la DMT2, desde al menos 6 meses antes de la Visita 1.
    Riesgo alto de acontecimientos CV, definido como antecedentes de intervención coronaria percutánea, cirugía de revascularización coronaria o pruebas angiográficas de estenosis del lumen > ó = 50% de 1 arteria coronaria como mínimo.
    E.4Principal exclusion criteria
    1.Previous MI (with the exception of definite secondary MI [e.g., due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anaemia])
    2. Previous stroke (transient ischaemic attacks [TIA] is not included in the stroke definition)
    3. Planned use of ADP receptor antagonists (e.g., clopidogrel, ticlopidine, prasugrel), dipyridamole, or cilostazol. Planned use of ASA treatment at doses >150 mg od.
    4. Planned coronary, cerebrovascular, or peripheral arterial revascularization.
    5. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study:
    - Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir.
    - CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily
    6. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses)
    7. Patients with known bleeding diathesis or coagulation disorder, or with uncontrolled hypertension (defined as a systolic BP > or = 180 mmHg and/or diastolic BP > or = 100 mmHg)
    8. History of previous intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days.
    9. Increased risk of bradycardic events (e.g., known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker.
    10. Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy)
    11. Renal failure requiring dialysis.
    1. IM previo (con excepción de IM secundario evidente [p.ej., debido a un procedimiento de revascularización coronaria, hipotensión intensa, urgencia hipertensiva, taquicardia o anemia grave])
    2. Ictus previo (el ataque isquémico transitorio [AIT] no se incluye dentro de la definición de ictus)
    3. Uso programado de antagonistas del receptor de ADP (p.ej., clopidogrel, ticlopidina, prasugrel), dipiridamol o cilostazol. Uso programado de tratamiento con AAS a dosis >150 mg OD.
    4. Revascularización coronaria, cerebrovascular o arterial periférica programada.
    5. Uso programado de tratamiento concomitante, oral o intravenoso, con inhibidores potentes del citocromo P450 3A4 (CYP3A4) o sustratos del CYP3A4 con índices terapéuticos estrechos, que no se puede suspender durante el transcurso del ensayo:
    - Inhibidores potentes: ketoconazol, itraconazol, voriconazol, telitromicina, claritromicina (pero no eritromicina o azitromicina), nefazadona, ritonavir, saquinavir, nelfinavir, indinavir y atanazavir.
    - Sustratos del CYP3A4 con índice terapéutico estrecho: quinidina y simvastatina a dosis diarias >40 mg o lovastatina a dosis diarias >40 mg.
    6. Necesidad de terapia crónica con anticoagulante oral o con heparina de bajo peso molecular (a dosis no profilácticas para el tratamiento de la trombosis venosa)
    7. Pacientes con diátesis hemorrágica conocida, trastornos de la coagulación o hipertensión no controlada (definida como una PA sistólica > ó = 180 mmHg y/o PA diastólica > ó = 100 mmHg)
    8. Antecedentes de hemorragia intracerebral previa en cualquier momento, hemorragia gastrointestinal (GI) en los 6 meses previos a la aleatorización o cirugía mayor en los 30 días previos a la aleatorización.
    9. Aumento del riesgo de experimentar acontecimientos bradicárdicos (p.ej., síndrome de disfunción sinusal conocido, bloqueo AV de segundo o tercer grado o síncope previo documentado que se sospecha que se debió a la bradicardia), a no ser que esté tratado con un marcapasos.
    10. Enfermedad hepática grave conocida (p. ej., ascitis y/o signos clínicos de coagulopatía)
    11. Insuficiencia renal que precisa diálisis.
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke (ischaemic, haemorrhagic or unknown etiology).
    Tiempo transcurrido desde la aleatorización hasta que ocurra por primera vez algún episodio de la combinación de muerte CV, IM o ictus (de etiología isquémica, hemorrágica o desconocida).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 35 months.
    Hasta aproximadamente 35 meses.
    E.5.2Secondary end point(s)
    Time from randomisation to first occurrence of any event from the composite of all-cause death, MI or stroke.
    Time from randomisation to death of CV cause.
    Time from randomisation to death of any cause.
    Tiempo transcurrido desde la aleatorización hasta que ocurra por primera vez algún episodio de la combinación de todas las causas de muerte, IM o ictus.
    Tiempo transcurrido desde la aleatorización hasta la muerte por causas CV.
    Tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to approximately 35 months.
    Hasta aproximadamente 35 meses.
    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 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) No
    E.8.2.2Placebo Yes
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA300
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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
    Last subject last visit.
    La última visita del último paciente incluido en el ensayo.
    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 months35
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months35
    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: 8500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8500
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state420
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5000
    F.4.2.2In the whole clinical trial 17000
    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
    Práctica Clínica 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 Decision2014-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-25
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