Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-017242-30
    Sponsor's Protocol Code Number:D5132C00001
    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:2010-11-26
    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 number2009-017242-30
    A.3Full title of the trial
    Ensayo multinacional, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la prevención de episodios tromboticos con Ticagrelor comparado con placebo sobre una base terapéutica de Acido Acetilsalicilico (ASA) en pacientes con historia de Infarto de Miocardio. A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction
    A.3.2Name or abbreviated title of the trial where available
    PEGASUS - TIMI 54
    A.4.1Sponsor's protocol code numberD5132C00001
    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 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 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 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 nameticagrelor
    D.3.2Product code AZD6140
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 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) 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 No
    D.IMP: 2
    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 nameticagrelor
    D.3.2Product code AZD6140
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) 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 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
    Scientific Terminology: Myocardial Infarction, Cardiovascular Death, Atherothombosis, Stroke

    Terminología científica: Infarto de miocardio, Muerte Cardiovascular, Aterotrombosis, Accidente isquémico transitorio

    Laymen Terminology: Heart Attack, Death from Heart Disease, Condition that leads to heart attack, and strok

    Terminología Laica: Infarto de miocardio, muerte debida a infarto de miocardio agudo, condiciones que conducen a un ataque al corazón y accidente isquémico transitorio
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10007648
    E.1.2Term Cardiovascular disease, unspecified
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del ensayo es comparar el efecto del tratamiento a largo plazo con
    ticagrelor frente a placebo en pacientes con antecedentes de IM y con alto riesgo de
    desarrollar acontecimientos aterotrombóticos y que reciben un tratamiento de base de ácido
    acetilsalicílico (AAS) sobre la tasa de acontecimientos del criterio de valoración compuesto de
    muerte cardiovascular, infarto de miocardio (IM) no mortal o ictus no mortal.
    La variable principal de eficacia es el tiempo hasta el primer episodio de cualquier
    acontecimiento tras la aleatorización del criterio de valoración compuesto de muerte
    cardiovascular, IM no mortal o ictus no mortal.
    E.2.2Secondary objectives of the trial
    El primer objetivo secundario es comparar el efecto del tratamiento a largo plazo con
    ticagrelor frente a placebo en pacientes con antecedentes de IM y con alto riesgo de
    desarrollar acontecimientos aterotrombóticos y que reciben un tratamiento de base de AAS
    sobre la tasa de acontecimientos de muerte cardiovascular.
    La variable de eficacia es el tiempo hasta que ocurre la muerte cardiovascular después de la
    aleatorización.
    El segundo objetivo secundario es comparar el efecto del tratamiento a largo plazo con
    ticagrelor frente a placebo en pacientes con antecedentes de IM y con alto riesgo de
    desarrollar acontecimientos aterotrombóticos y que reciben un tratamiento de base de AAS
    sobre la tasa de acontecimientos de mortalidad por todas las causas.La variable de eficacia es el tiempo hasta que ocurre la mortalidad por todas las causas
    después de la aleatorización.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subestudio de Biomarcadores cardiovasc. (09-09-2010)
    Versión: FINAL Objetivos:
    Evaluar el valor de los biomarc. para predecir los acontecim. isquém./trombót. y hemorrágicos.
    Evaluar si los pac. con mayor riesgo identificado mediante biomarc. experimentan mayor reducc. del riesgo absoluto y/o relativo de acontecim. isquém./ trombót. con el tto. a largo plazo con ticagrelor frente a placebo.
    Evaluar la correlación entre inhib. de la agreg. plaquet. y resultados isquém./ trombót. y hemorrág..
    E.3Principal inclusion criteria
    1. Hombres y mujeres >50 años de edad.
    2. Antecedentes documentados de presunto IM espontáneo (excluyendo IM periprocedimiento
    conocido o IM secundario definido [por ej., debido a hipotensión profunda,
    hipertensión que requiere intervención de urgencia, taquicardia o anemia profunda]),
    habiéndose producido su IM más reciente de 1 a 3 años antes de la aleatorización y que
    tienen al menos 1 de los siguientes factores de riesgo:
    Edad 65 años
    Diabetes mellitus que requiere medicación
    Antecedentes documentados de un segundo presunto IM espontáneo (>1 año)
    Evidencia angiográfica de arteriopatía coronaria (AC) multivaso (estenosis
    50% en dos zonas importantes de la arteria coronaria mayor [es decir,
    descendente anterior izquierda, rama intermedia, circunfleja izquierda, arteria
    coronaria derecha] que afecta al vaso principal, a una rama importante o a un
    bypass aorto-coronario)1.
    Disfunción renal crónica no terminal (aclaramiento de creatinina calculado
    mediante la ecuación de Cockcroft Gault <60ml/min)2.
    3. Pacientes actualmente en tratamiento con AAS y que lo toleran y que pueden recibir la
    dosis especificada en el protocolo de 75 - 150 mg una vez al día a lo largo de la duración
    del ensayo.
    4. Las mujeres en edad fértil (es decir, no esterilizadas químicamente ni quirúrgicamente o no
    post-menopáusicas) deberán dar negativo en una prueba de embarazo en orina en el
    reclutamiento (confirmada por una prueba de embarazo en sangre en el laboratorio central).
    Las mujeres en edad fértil deberán acceder a utilizar un método anticonceptivo
    médicamente aceptado fiable a juicio del investigador.
    5. Firma del consentimiento informado con anterioridad a la realización de cualquiera de los
    procedimientos específicos del estudio.
    E.4Principal exclusion criteria
    1. Uso planificado de bloqueadores del receptor ADP (por ej., clopidogrel, ticlopidina,
    prasugrel), dipiridamol o cilostazol
    2. Revascularización coronaria, cerebrovascular o periférica planificada
    3. Tratamiento concomitante oral o intravenoso con inhibidores fuertes del citocromo
    P450 3A (CYP3A), sustratos del CYP3A con índices terapéuticos estrechos o
    inductores fuertes del CYP3A que no se pueden suspender durante el ensayo
    Inhibidores fuertes: ketoconazol, itraconazol, voriconazol, telitromicina,
    claritromicina (pero no eritromicina ni azitromicina), nefazadona, ritonavir,
    saquinavir, nelfinavir, indinavir, atanazavir, más de 1 litro diario de zumo de
    pomelo
    Sustratos con un índice terapéutico estrecho: ciclosporina, quinidina,
    simvastatina en dosis >40 mg al día o dosis de lovastatina >40 mg al día3
    Inductores fuertes: rifampina/rifampicina, rifabutina, fenitoína, carbamazepina,
    fenobarbital
    4. Necesidad de tratamiento anticoagulante oral crónico o uso crónico de heparina de
    bajo peso molecular (en dosis para en tratamiento de la trombosis venosa, no
    profilácticas)
    5. Pacientes con diatesis hemorrágica o trastorno de la coagulación conocido
    6. Antecedentes de hemorragia intracraneal previa en cualquier momento, hemorragia
    gastrointestinal (GI) en los últimos 6 meses, o cirugía mayor dentro de 30 días
    7. Ictus isquémico en los últimos 14 días
    8. Los pacientes considerados de riesgo de acontecimientos bradicárdicos ([por ej.,
    síndrome de disfunción sinusal o bloqueo aurículoventricular (AV) de segundo o
    tercer grado conocido]), salvo que se les haya implantado un marcapasos
    permanente
    9. Bypass aorto-coronario en los últimos 5 años
    10. Enfermedad hepática grave conocida (por ej., ascitis o signos de coagulopatía)
    11. Insuficiencia renal que requiere diálisis o necesidad prevista de diálisis durante el
    transcurso del ensayo
    12. Embarazo o lactancia
    13. Esperanza de vida < 1 año
    14. Cualquier trastorno que en opinión del investigador podría comprometer la
    seguridad del paciente o le convierta en inadecuado para participar en este ensayo
    (por ej., neoplasia maligna distinta a cáncer de piel de células escamosas o basales)
    15. Sospecha de la incapacidad del paciente para cumplir con los procedimientos del
    ensayo y/o seguimiento (por ej., alcoholismo o drogadicción)
    16. Participación en un ensayo previo con ticagrelor si se va a tratar con ticagrelor.
    Aleatorización previa en el presente ensayo
    17. Implicación en la planificación y/o realización del estudio (aplicable al personal de
    AstraZeneca y/o al personal del centro del estudio).
    18. Participación en otro ensayo clínico con un producto en investigación en los 30 días
    anteriores
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es el tiempo hasta el primer episodio de cualquier
    acontecimiento del criterio de valoración compuesto de muerte cardiovascular, IM no mortal o
    ictus no mortal. El análisis principal comparará el tiempo desde la aleatorización hasta el
    primer episodio de cualquier acontecimiento en el criterio de valoración compuesto utilizando
    el modelo de riesgos proporcionales de Cox con un factor por grupo de tratamiento. Cada
    dosis de ticagrelor se analizará por separado frente a placebo.
    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 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 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.8.3 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 concerned26
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA400
    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
    El final del estudio se define como "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 months2
    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 months2
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7780
    F.4.2.2In the whole clinical trial 21000
    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 Decision2011-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 20:41:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA