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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   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).


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    Summary
    EudraCT Number:2014-005363-33
    Sponsor's Protocol Code Number:ESR-14-10048
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-24
    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 number2014-005363-33
    A.3Full title of the trial
    Reducing Micro Vascular dysfunction In revascularized STEMI patients by off-target properties of ticagrelor
    Reducción de disfunción microvascular en pacientes con STEMI revascularizado por propiedades off-target de ticagrelor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Discovering beneficial properties of ticagrelor in acute myocardial
    infarction
    Descubriendo las propiedades beneficiosas de ticagrelor en el infarto agudo de miocardio
    A.3.2Name or abbreviated title of the trial where available
    REDUCE-MVI
    A.4.1Sponsor's protocol code numberESR-14-10048
    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 SponsorVU university medical center
    B.1.3.4CountryNetherlands
    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 supportVU university medical center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínico San Carlos
    B.5.2Functional name of contact pointUnidad de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/Profesor Martín Lagos, s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913303793
    B.5.5Fax number+31204443984
    B.5.6E-mailm.vanleeuwen@vumc.nl
    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 90 mg film coated tablets
    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 / brilique
    D.3.4Pharmaceutical form 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.3.9.3Other 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 Prasugrel / efient
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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 nameefient
    D.3.2Product code EU/1/08/503/015
    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 INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.4EV Substance CodeSUB30236
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    ST elevation myocardial infarction (STEMI)
    Infarto de miocardio con elevación del ST
    E.1.1.1Medical condition in easily understood language
    heart attack
    ataque al corazón
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 determine if ticagrelor at treatment steady state (30 days
    maintenance therapy) will be associated to an improved microvascular
    function as compared to prasugrel in revascularized STEMI patients.
    Determinar si ticagrelor en fase estable de tratamiento (terapia de mantenimiento de 30 días) se asociará a una función microvascular mejorada en comparación con prasugrel en pacientes con STEMI revascularizado
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent
    2. Patients presenting with STEMI <12 hours
    3. Successful PCI of the infarct-related vessel with a modern DES
    4. Intermediate stenosis in non-infarct-related vessel (50-90%)
    1. Provisión de consentimiento informado.
    2. Pacientes que se presentan con un STEMI < 12 horas
    3. ICP del vaso relacionado con el infarto con éxito con un stent liberador de fármaco (DES) moderno.
    4. Estenosis intermedia en un vaso no relacionado con el infarto (50-90%).
    E.4Principal exclusion criteria
    1. history of myocardial infarction
    2. Participation in another clinical study with an investigational product
    during the preceding 30 days
    3. history of cerebrovascular accident (CVA) or 'transient ischaemic
    attack' (TIA)
    4. History of intracranial haemorrhage
    5. indication or use of oral anticoagulant therapy (i.e. acenocoumarol)
    6. severe liver dysfunction (Child-Pughscore 10?15)
    7. congestive heart failure
    8. cardiogenic shock
    9. left ventricular ejection fraction < 35%
    10. bleeding diathesis
    11. age ? 75 or < 18
    12. body weight < 60 kg
    13. gout
    14. coagulation disorders
    15. severe pulmonary disease
    16. pregnancy and breast feeding
    17. limited life expectancy
    18. platelet count < 100 000/mm3
    19. history of drug addiction or alcohol abuse in the past 2 years
    20. need for chronic nonsteroidal anti-inflammatory drug
    21. creatinine clearance <30 mL/min or dialysis
    22. chronic total occlusion (CTO)
    23. Left main disease
    24. allergy or contra-indication for ticagrelor or prasugrel
    25. Contra-indication for adenosine
    26. Patients unable to be followed on-site
    27. Unable to undergo or contra-indications for MRI
    28. Contra-indication for DES
    29. Inability to obtain informed consent
    1. infarto previo.
    2. participación en otro ensayo clínico con un producto de investigación en los 30 días precedentes.
    3. accidente cerebrovascular (ACV) previo o ataque isquémico transitorio (AIT).
    4. Historia de hemorragia intracraneal.
    5. Indicación o uso de terapia anticoagulante (i.e. acenocoumarol).
    6. Disfunción de hígado severa (Child-Pughscore 10?15).
    7. Insuficiencia cardiaca congestiva.
    8. Shock cardiogénico.
    9. Fracción de eyección del ventrículo izquierdo < 35%
    10. diátesis hemorrágica
    11. Edad >= 75 o <18
    12. Peso < 60 Kg
    13. Gota
    14. Desorden en la coagulación.
    15. Enfermedad pulmonar severa.
    16. Embarazo y lactancia.
    17. Esperanza de vida limitada.
    18. Conteo plaquetario < 100 000/mm3.
    19. Historia de drogadicción o abuso del alcohol en los últimos 2 años.
    20. Necesidad de medicamento anti-inflamatorio no-esteroidal crónico.
    21. Aclaramiento de creatinina <30 mL/min o diálisis.
    22. Oclusión total crónica.
    23. Enfermedad de la arteria coronaria izquierda principal.
    24. Alergia o contraindicación a ticagrelor o prasugrel.
    25. Contraindicación a la adenosina.
    26. Pacientes que no puedan acudir al seguimiento en el centro
    27. Pacientes incapaces de hacerse o con contraindicación a resonancia magnética.
    28. Contraindicación a DES (stents liberadores de fármaco).
    29. Incapacidad de obtener el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Index of microcirculatory resistance (IMR) at treatment steady state (1
    month after primary PCI) in the infarct-related vessel, assessed with a
    pressure wire (Certus, St Jude Medical, St Paul,MN, USA).
    Índice de resistencia microcirculatoria (IMR) en un momento estacionario del tratamiento (1 mes después de la ICP) en el vaso relacionado con el infarto, medido con una guía de presión (Certus, St Jude Medical, St Paul,MN, USA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after primary PCI
    1 mes después de la ICP primaria
    E.5.2Secondary end point(s)
    - The reactive hyperemia index (RHI) at treatment steady state (1 month
    after primary PCI), assessed
    with endopath system (Endopath; Itamar Medical Ltd., Cesarea, Israel).
    - The delta IMR between baseline and follow-up in both the infarctrelated
    vessel and non-infarct related vessel.
    - The delta RHI between baseline and follow-up
    - The level of endothelial function as measured by several parameters
    (endothelin-1, NO synthase, e-NOS and dimethylarginine ) at follow-up
    - Índice de hiperemia reactiva (RHI) en un momento estacionario del tratamiento (1 mes después de la ICP primaria), medido con el sistema endopath (Endopath; Itamar Medical Ltd., Cesarea, Israel).
    - Diferencia entre IMR basal y en el seguimiento, tanto en el vaso relacionado con el infarto como en el no relacionado.
    - Diferencia entre RHI basal y RHI al seguimiento.
    - Nivel de función endotelial medida por varios parámetros (endothelin-1, NO synthase, e-NOS y dimethylarginine ) al seguimiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    - RHI: Baseline (1 day after primary PCI) and follow-up (1 month and 1
    year)
    - IMR: Baseline (directly after primary PCI) and follow-up ( 1 month)
    - Endothelial function blood samples: Baseline (directly after primary
    PCI) and follow-up (3 days, 1 month and 1 year)
    - RHI: Basal (1 día después de la ICP primaria) y en el seguimiento (1 mes y 1 año).
    - IMR: Basal (justo después de la ICP primaria) y al seguimiento (1 mes)
    - Función endotelial de muestras de sangre: Basal (justo después de la ICP primaria) y al seguimiento (3 dias, 1 mes y 1 año).
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    After the subject has ended the participation in the trial, treatment and
    care will be left to the treating physician
    Después de que el sujeto haya finalizado con la participación en el ensayo, el tratamiento y los cuidados se dejarán a la elección de su médico
    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 Decision2016-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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