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    The EU Clinical Trials Register currently displays   39587   clinical trials with a EudraCT protocol, of which   6490   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-002683-14
    Sponsor's Protocol Code Number:DSE-EDO-01-15-EU
    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:2016-12-01
    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 number2016-002683-14
    A.3Full title of the trial
    Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist-based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement. (EDOXABAN TREATMENT VERSUS VKA IN PATIENTS WITH AF UNDERGOING PCI - ENTRUST AF-PCI).
    Evaluación de la seguridad y eficacia del tratamiento antitrombótico con
    edoxabán en comparación con un antagonista de la vitamina K (AVK), tras
    una intervención coronaria percutánea (ICP) con colocación de stent
    satisfactoria. (TRATAMIENTO CON EDOXABÁN COMPARADO CON AVK EN
    PACIENTES QUE PADECEN FIBRILACIÓN AURICULAR SOMETIDOS A ICP –
    ENTRUST - FA ICP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EDOXABAN TREATMENT VERSUS VKA IN PATIENTS WITH AF UNDERGOING PCI.
    TRATAMIENTO CON EDOXABÁN COMPARADO CON AVK EN PACIENTES QUE
    PADECEN FIBRILACIÓN AURICULAR SOMETIDOS A ICP.
    A.4.1Sponsor's protocol code numberDSE-EDO-01-15-EU
    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 SponsorDaiichi Sankyo Europe GmbH
    B.1.3.4CountryGermany
    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 supportDaiichi Sankyo Europe GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Europe GmbH
    B.5.2Functional name of contact pointLate Phase Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressZielstattstrasse 48
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81379
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989 7808 614
    B.5.5Fax number+4989 7808 561
    B.5.6E-mailPetra.laeis@daiichi-sankyo.eu
    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 Lixiana 15 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe 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 nameedoxaban
    D.3.2Product code DU-176b
    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 INNedoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 Lixiana 30 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe 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 nameedoxaban
    D.3.2Product code DU-176b
    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 INNedoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 3
    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 Lixiana 60 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo EUrope 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 nameedoxaban
    D.3.2Product code DU-176b
    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 INNedoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.4EV Substance CodeSUB32701
    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) 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: 4
    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 Sintrom 4 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderMerus Labs Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameacenocumarol
    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 INNacenocumarol
    D.3.9.1CAS number 152-72-7
    D.3.9.4EV Substance CodeSUB05211MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 5
    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 ASS HEXAL Protect 100 mg magensaftreistente Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameacetylsalicylic acid
    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.3.9.4EV 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.IMP: 6
    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 Clopidogrel Amneal 75 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAmneal Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameclopidogrel
    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 INNclopidogrel
    D.3.9.1CAS number 113665-84-2
    D.3.9.4EV Substance CodeSUB13395MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 7
    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 Phenoprogamma 3
    D.2.1.1.2Name of the Marketing Authorisation holderWorwag Pharma GmbH and Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namephenprocoumon
    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 INNphenprocoumon
    D.3.9.1CAS number 435-97-2
    D.3.9.4EV Substance CodeSUB09781MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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: 8
    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 Efient 5 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe 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 nameprasugrel
    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 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 number5
    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: 9
    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 Efient 10 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe 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 nameprasugrel
    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 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.IMP: 10
    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 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
    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.3.9.4EV 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: 11
    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 Previscan 20 mg, comprime quadrisecable
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SANTE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namefluindione
    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 INNfluindione
    D.3.9.1CAS number 957-56-2
    D.3.9.4EV Substance CodeSUB07692MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 12
    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 Warfarin Teva 1 mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSun Pharmaceutical Industries Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 namewarfarin sodium
    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 INNwarfarin sodium
    D.3.9.1CAS number CAS 129-06-6
    D.3.9.4EV Substance CodeSUB05128MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 13
    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 Warfarin Teva 2.5 mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSun Pharmaceutical Industries Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 namewarfarin sodium
    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 INNwarfarin sodium
    D.3.9.1CAS number CAS 129-06-6
    D.3.9.4EV Substance CodeSUB05128MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    E.1.1.1Medical condition in easily understood language
    Subjects with atrial fibrillation (AF) following successful PCI with stent placement.
    Pacientes con fibrilación auricular (FA) tras una ICP con colocación de
    stent satisfactoria.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    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 is to compare a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12 antagonist and 1-12 months ASA in subjects with AF following successful PCI with stent placement in terms of the incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB).
    El objetivo principal es la comparación entre un tratamiento
    antitrombótico de 12 meses de duración con edoxabán en combinación
    con clopidogrel u otro antagonista del receptor P2Y12 y un tratamiento
    con un antagonista de la vitamina K (AVK) en combinación con
    clopidogrel u otro antagonista del receptor P2Y12 y 1-12 meses de ácido acetilsalicílico (AAS) en pacientes que padecen FA tras una ICP con
    colocación de stent satisfactoria, en términos de incidencia de
    hemorragia mayor o no mayor clínicamente relevante, según los criterios definidos por la ISTH.
    E.2.2Secondary objectives of the trial
    Secondary exploratory objectives of the study are to compare the edoxaban-based antithrombotic regimen to the VKA-based antithrombotic regimen with regard to:
    - MEE, defined as the composite of CV death, stroke, SEE, spontaneous MI and definite stent thrombosis,
    - Net clinical benefit (NCB), defined as the composite of CV death, stroke, SEE, spontaneous MI, definite stent thrombosis and ISTH-defined major bleeding.
    - Main thromboembolic event, defined as composite of cardiac or thromboembolic death, ischemic stroke, SEE, spontaneous MI and definite stent thrombosis.
    - ISTH-defined major bleeding
    - Any bleeding defined as the composite of major, clinically relevant non-major and minor bleeding
    - Symptomatic ICH
    - Composite of stroke and SEE
    - Composite of all-cause death, stroke, SEE, spontaneous MI and definite stent thrombosis
    - Composite of CV death, spontaneous MI and definite stent thrombosis
    - Safety parameters , laboratory parameters, ECG and vital signs.
    Objv. secundarios exploratorios del ensayo son comparar el tratamiento
    antitrombótico con edoxabán y el tratamiento antitrombótico con AVK
    con respecto a los siguientes puntos:
    -Variable principal de eficacia, definida como el compuesto de muerte
    CV, acc. cerebrovascular, EES, IM espontáneo y trombosis de stent
    definitiva.
    -Beneficio clínico neto, definido como el compuesto de muerte CV, acc.
    cerebrovascular, EES, IM espontáneo, trombosis de stent definitiva y
    hemorragia mayor según ISTH.
    -Ev. tromboembólico principal, definido como el compuesto de muerte
    cardíaca o tromboembólica, acc. cerebrovascular isquémico, EES, IM
    espontáneo y trombosis de stent definitiva.
    -Hemorragia mayor según ISTH
    -Cualquier hemorragia definida como el compuesto de hemorragia
    mayor, no mayor clínicamente relevante y menor
    -Hemorragia intracraneal sintomática
    El resto de obj. secundarios están descritos en la pág. 2 de la sinopsis
    del protocolo v1 30May2016
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.OAC indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting.
    Eligibility is assessed 4 hours after sheath removal and within 5 days after successful PCI with stent placement. If a staged PCI is planned, eligibility is assessed after completion of the last stage.

    Successful PCI definition:
    The success of a PCI procedure is defined by 2 interrelated components: angiographic findings, procedural / clinical outcomes as detailed below:
    Angiographic Success
    A minimum stenosis diameter of < 20% (as visually assessed by angiography - residual blockage or stenosis reduced to less than 20% of the artery’s diameter).
    Sufficient enlargement of the lumen at the target site to improve coronary artery blood flow with final TIMI flow grade 3 (visually assessed by angiography), without occlusion of a significant side branch, flow-limiting dissection, distal embolization, or angiographic thrombus.
    Procedural Success
    No major in-hospital clinical complications(e.g. ongoing ISTH major or clinical relevant non-major procedural bleeding at the time of randomization, stroke, emergency CABG).
    In summary, a clinically successful PCI requires both anatomic and procedural success along with relief of signs and/or symptoms of myocardial ischemia at the time of randomization.
    1. Indicación de anticoagulantes orales para el tratamiento de la fibrilación auricular por al menos 12 meses tras una intervención
    coronaria percutánea con colocación de stent satisfactoria.
    La idoneidad de los pacientes preseleccionados se evalúa 4 horas
    después de la extracción de la vaina y en el plazo de 5 días tras la
    realización de la intervención coronaria percutánea satisfactoria. Si está previsto realizar la ICP en varias etapas, la idoneidad se evalúa después de la finalización de la última etapa.
    Definición ICP satisfactoria:
    Resultado satisfactorio de ICP está definido por dos componentes
    interrelacionados: hallazgos angiográficos, resultados de procedimientos / clínicos como se detalla a continuación:
    El éxito angiográfico Un diámetro mínimo estenosis de <20% (tal como se evaluó visualmente por angiografía - obstrucción residual o estenosis reducida a menos de 20% del diámetro de la arteria).
    Ampliación suficiente del lumen en el sitio diana para mejorar el flujo
    sanguíneo de la arteria coronaria con flujo final TIMI grado 3 (evaluada
    visualmente por angiografía), sin oclusión de una rama lateral
    significativa, el flujo de limitación de la disección, embolización distal, o
    trombo angiográfico.
    Éxito del procedimiento
    Ninguna de las grandes complicaciones clínicas (por ejemplo, sangrado
    en curso ISTH mayor o clínicamente relevante no mayor al del momento de la aleatorización, accidente cerebrovascular, CABG de emergencia) en el hospital.
    En resumen, un PCI clínicamente satisfactoria requiere tanto éxito
    anatómico y de procedimiento, junto con el alivio de los signos y / o
    síntomas de isquemia miocárdica en el momento de la aleatorización.
    E.4Principal exclusion criteria
    Bleeding risks or systemic conditions
    1.Known bleeding diathesis, including but not limited to,
    a.Uncontrolled active bleeding, encompassing both ISTH major and clinically relevant non-major bleeding, preceding randomization.
    b.Lesion or condition, if considered to be a significant risk for major bleeding.
    This may include but is not limited to: unresolved gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding (e.g. malignancies with metastasis), recent unresolved brain or spinal injury, recent brain, spinal or ophthalmic surgery, any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms (of more than 3.5 cm) or major intraspinal or intracerebral vascular abnormalities.
    Medication-related
    2.INR > 2.5 (the subject can be reconsidered at a later time, but within 5 days of sheath removal).
    3.Contraindication to edoxaban, VKA, ASA and/or P2Y12 antagonists;
    4.Concomitant treatment with other antithrombotic agents, fibrinolytic therapy and chronic nonsteroidal anti-inflammatory drugs (NSAIDs).
    Concomitant conditions and therapies
    5. Critically ill or hemodynamically unstable subjects (at the time of randomization) including:
    a.cardiogenic shock or acute decompensated heart failure, with the requirement for vasopressor agents or inotropic support or mechanical support to support circulation
    b.respiratory failure requiring endotracheal intubation and mechanical ventilation.
    6.Any prior mechanical valvular prosthesis;
    7.Planned coronary or vascular intervention or major surgery within 12 months; Randomization must be deferred to the last stage in a multistep, multivessel PCI procedure;
    8.Moderate or severe mitral stenosis;
    9.Ischemic stroke within 2 weeks prior to randomization;
    10.Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or diastolic BP ≥ 120 mmHg;
    11.Severe renal impairment with estimated creatinine clearance (CrCL) < 15 mL/min or on dialysis;
    12.Known abnormal liver function prior to randomization (incl. hepatic disease or biochemical evidence of significant liver derangement known prior to randomization
    Other exclusion criteria
    13.Any of the following abnormal local laboratory results prior to randomization:
    a.Platelet count < 50 x109/L
    b.Hemoglobin < 8 mg/dL
    14.Unable to provide written IC;
    15.Female subject of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);
    16.Pregnant or breast-feeding subjects;
    17.Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
    18.Participating in another clinical trial that potentially interferes with the current study;
    19.Previous randomization in this study;
    20.Known drug or alcohol dependence within the past 12 months as judged by the Investigator;
    21.Life expectancy < 12 months.
    Riesgos de hemorragia o trastornos sistémicos
    1.Diátesis hemorrágica conocida, que comprenda entre otras a,
    a.Hemorragia activa incontrolable, abarca tanto hemorragias mayors
    como no mayors según ISTH, antes de la aleatorización.
    b.Lesión o afección que constituya un riesgo significativo de hemorragia
    mayor. Puede comprender, entre otras: ulceración gastrointestinal no resuelta, presencia de neoplasias malignas con alto riesgo de hemorragia (p.ej.tumores malignos con metastasis), lesión cerebral o medular reciente no resulta, int. quirúr. reciente oftálmica, cerebral o medular, cual. hemorragia intracranial, varices esofágicas conocidas o
    sospechadas, malformaciones arteriovenosas, aneurismas vasculares
    (de más de 3.5 cm) o anomalías vasculares cerebrales o intrarraquídeas
    graves.
    2.INR > 2.5 (admission pac. podrá ser reconsiderada post., pero un plazo de 5 días desde la extracción de la vaina).
    3. Contraindicación a edoxabán, AVK, AAS y/o antagonistas del receptor P2Y12.
    4.Tto. concomitante con otros agentes antitrombóticos, tto fibrinolítico y uso crónico de antinflamatorios no esteroideos (AINE).
    Transtornos y tto concomitants
    5.Pac. con enf. en estado crítico o hemodinámicamente inestables (en el momento de la aleatorización) como:
    a.choque cardiógeno o insuf. cardíaca aguda descompensada, con
    necesidad de vasopresores o apoyo inotrópico o mecánico para la
    circulación.
    b.insuf. respiratoria que requiere intubación endotraqueal y ventilación
    mecánica.
    6.Cualq. prótesis valvular mecánica previa.
    7.Intervención quir. planificada de cirugía mayor coronaria o vascular en el plazo de 12 meses; en caso de una intervención coronaria percutánea multietapa y multivaso, la aleatorización deberá aplazarse hasta la última etapa.
    8.Estenosis moderada o grave.
    9. Acc. cardiovascular isquémico en las 2 sem. previas a la
    aleatorización.
    10.Hipertensión arterial grave no controlada, con una presión arterial
    sistólica ≥ 180 mmHg y/o diastólica ≥ 120 mmHg.
    11.Insuficiencia renal grave con un aclaramiento de creatinina estimado <15 ml/min o en diálisis.
    12.Función hepática anormal conocida antes de la aleatorización
    (enfermedad hepática o evidencia bioquímica de trastorno hepático
    significativo conocido antes de la aleatorización).
    Otros criterios de exclusión
    13.Resultado anormal en cualquiera de las siguientes pruebas de
    laboratorio antes de la aleatorización:
    a.Número de trombocitos < 50 X 109/l
    b.Hemoglobina < 8 mg/dl.
    14.Incapacidad de otorgar el consentimiento informado por escrito.
    15.Mujeres en edad fértil que no utilicen anticonceptivos adecuados, p.e. que no hayan sido esterilizadas quirúrgicamente o no estén en el período posmenopáusico (definida como no menstruación durante 2 años sin causa alternativa);
    16.Mujeres embarazadas o que estén dando el pecho.
    17.Valoración de que el paciente probablemente no cumplirá con los
    procedimientos del ensayo o no participará en todo el seguimiento.
    18.Estar participando actualmente en otro ensayo clínico que podría
    interferir con el presente ensayo.
    19.Aleatorización previa en este ensayo.
    20.Dependencia de drogas o alcohol conocida en los últimos 12 meses,
    según el juicio del Investigador.
    21.Esperanza de vida <12 meses.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the composite of major or clinically relevant non-major bleeding (MCRB) defined according to the ISTH-defined bleeding definitions, analyzed as time to first occurrence of any component.
    El criterio de valoración principal es el compuesto de hemorragia mayor
    o no mayor clínicamente relevante, según las definiciones de hemorragia dadas por la ISTH, analizado como el tiempo hasta la primera manifestación de cualquier component.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First occurrence of any component.
    Primera aparición de cualquiera de los componentes.
    E.5.2Secondary end point(s)
    - Main efficacy endpoint (MEE), defined as the composite of cardiovascular (CV) death, stroke, systemic embolic events (SEE), myocardial infarction (MI) and definite stent thrombosis.
    - Net clinical benefit (NCB), defined as the composite of CV death, stroke, SEE, MI, definite stent thrombosis and ISTH-defined major bleeding.
    - Main thromboembolic event, defined as composite of cardiac or thromboembolic death, ischemic stroke, SEE, MI and definite stent thrombosis.
    - ISTH-defined major bleeding
    - Any bleeding defined as the composite of major, clinically relevant non-major and minor bleeding (ISTH definition)
    - Symptomatic intracranial hemorrhage (ICH)
    - Composite of stroke and SEE
    - Composite of all-cause death, stroke, SEE, MI and definite stent thrombosis
    - Composite of CV death, MI and definite stent thrombosis
    - The single components of the composite primary and secondary endpoints mentioned above are explored, as well as specific subcategories (e.g., hemorrhagic, ischemic and undetermined stroke)
    - Safety parameters such as (serious) adverse events, laboratory parameters, ECG and vital signs.
    -El criterio de valoración principal de eficacia, definido como el
    compuesto de muerte cardiovascular, accidente cerebrovascular,
    eventos embólicos sistémicos, infarto de miocardio espontáneo y
    trombosis de stent definitiva.
    -El beneficio clínico neto, definido como el compuesto de muerte
    cardiovascular, accidente cerebrovascular, eventos embólicos
    sistémicos, infarto de miocardio espontáneo, trombosis de stent
    definitiva y hemorragia mayor según los criterios definidos por la ISTH.
    -El evento tromboembólico principal, definido como el compuesto de
    muerte cardíaca o tromboembólica, accidente cerebrovascular
    isquémico, eventos embólicos sistémicos, infarto de miocardio
    espontáneo y trombosis de stent definitiva.
    -Hemorragia mayor según los criterios de la ISTH.
    -Cualquier hemorragia definida como el compuesto de hemorragia
    mayor, no mayor clínicamente relevante y menor (según la definición de la ISTH).
    -Hemorragia intracraneal sintomática.
    -Compuesto de accidente cerebrovascular y eventos embólicos
    sistémicos
    -Compuesto de todas las causas de muerte, accidente cerebrovascular,
    eventos embólicos sistémicos, infarto de miocardio espontáneo y
    trombosis de stent definitiva.
    -Compuesto de muerte cardiovascular, infarto de miocardio espontáneo
    y trombosis de stent definitiva.
    -Se exploran los componentes individuales del criterio de valoración
    compuesto principal y de los secundarios mencionados anteriormente,
    así como las subcategorías específicas (p. ej. accidente cerebrovascular
    hemorrágico, isquémico e indeterminado).
    -Los parámetros de seguridad, como los acontecimientos adversos
    (graves), los parámetros de laboratorio, el electrocardiograma y las
    constantes vitals.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints are analyzed as time to first occurrence of any of its components.
    Todos los criterios de valoración secundarios se analizan según el tiempo hasta la primera manifestación de uno cualquiera de sus components.
    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 Yes
    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 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) 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA226
    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
    Austria
    Belgium
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Lithuania
    Netherlands
    Poland
    Portugal
    Romania
    Serbia
    Spain
    Switzerland
    Taiwan
    Ukraine
    United Kingdom
    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
    LPLV
    Última visita último paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1144
    F.4.2.2In the whole clinical trial 1500
    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)
    None
    Ninguno
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-06
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