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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:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-12
    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 ConcernedItaly - Italian Medicines Agency
    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).
    Valutazione della sicurezza e dell’efficacia di un regime antitrombotico basato su edoxaban rispetto ad un regime basato sugli antagonisti della vitamina K a seguito di riuscito intervento coronarico percutaneo (ICP) con inserimento di stent. (Trattamento con EDOXABAN_confrontato a
    VKA in pazienti con fibrillazione atriale [FA] sottoposti a ICP – ENTRUST - AF PCI).
    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.
    Trattamento con EDOXABAN confrontato a VKA in pazienti FA sottoposti a ICP.
    A.3.2Name or abbreviated title of the trial where available
    EDOXABAN TREATMENT VERSUS VKA IN PATIENTS WITH AF UNDERGOING PCI.
    -
    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 number0049897808614
    B.5.5Fax number0049897808561
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor codeedoxaban
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 AuthorisationAustria
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACENOCUMAROLO
    D.3.9.1CAS number 152-72-7
    D.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNacetylsalicylic acid
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 IMP
    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.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor code-
    D.3.9.4EV Substance Code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 IMP
    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 code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNwarfarin sodium
    D.3.9.1CAS number 129-06-6
    D.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNwarfarin sodium
    D.3.9.1CAS number 129-06-6
    D.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    Subjects with atrial fibrillation (AF) following successful PCI with stent placement.
    Soggetti con FA (fibrillazione atriale) a seguito di riuscito ICP (intervento coronarico percutaneo) con inserimento di stent.
    E.1.1.1Medical condition in easily understood language
    Subjects with atrial fibrillation (AF) following successful PCI with stent placement.
    Soggetti con FA (fibrillazione atriale) a seguito di riuscito ICP (intervento coronarico percutaneo) con inserimento di stent.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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).
    L’obiettivo primario è di confrontare un regime antitrombotico di 12 mesi a base di edoxaban in combinazione con clopidogrel o un altro antagonista del recettore P2Y12 con un regime a base di un antagonista della vitamina K (VKA) in combinazione con clopidogrel o un altro antagonista del recettore P2Y12 e 1-12 mesi di ASA in soggetti con fibrillazione atriale (FA) a seguito di riuscito intervento coronarico percutaneo (ICP) con inserimento di stent in termini di incidenza di emorragie maggiori o emorragie clinicamente rilevanti non-maggiori (MCRB) secondo la definizione fornita da ISTH (International Society on Thrombosis and Haemostasis).
    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.
    Gli obiettivi esploratori secondari della presente sperimentazione prevedono di confrontare il regime antitrombotico a base di edoxaban conil regime antitrombotico a base di VKA per quanto attiene a:
    • Il principale endpoint dell’efficacia (MEE), definito come la combinazione di morte cardiovascolare (CV), ictus, eventi embolici sistemici (EES), infarto miocardico (IM) spontaneo e specifica trombosi dello stent;
    • Beneficio clinico netto (BCN) , definito come la combinazione di morte cardiovascolare (CV), ictus, EES, IM spontaneo, specifica trombosi dello stent ed emorragie maggiori secondo la definizione fornita da ISTH;
    • Principale evento tromboembolico, definito come la combinazione di morte cardiaca o tromboembolica, ictus
    ischemico, ESS, IM spontaneo e specifica trombosi dello stent;
    • Emorragie maggiori secondo la definizione fornita da ISTH;
    • Qualsiasi emorragia definita come combinazione di emorragie maggiori, clinicamente rilevanti non-maggiori e minori (secondo la definizio
    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. Indicazione di terapia anticoagulante orale (OAC) per fibrillazione atriale
    per un periodo di almeno 12 mesi a seguito di riuscito intervento coronarico percutaneo (ICP) con applicazione di stent.

    La determinazione dell’idoneità dei soggetti ai quali è stato fatto uno
    screening preventivo è valutata 4 ore dopo la rimozione della guaina ed
    entro 5 giorni dalla buona riuscita dell’intervento coronarico percutaneo
    (ICP). Se è stato pianificato un intervento coronarico percutaneo (ICP) a
    step, l’idoneità è valutata dopo il completamento dell’ultimo step.



    Definizione ICP di successo:
    Il successo di una procedura di ICP è definito da 2 componenti correlati: risultati angiografici, procedurali / risultati clinici come qui di seguito dettagliato:

    Successo angiografico
    Un diametro minimo stenosi <20% (visivamente valutata mediante angiografia - blocco residuo o stenosi ridotta a meno del 20% del diametro della arteria).
    Sufficiente allargamento del lume presso il sito di destinazione per migliorare il flusso di sangue dell'arteria coronaria con un flusso finale TIMI di grado 3 (visivamente valutato da angiografia), senza occlusione di un ramo laterale significativo, dissezioni flusso-limitanti, embolizzazione distale o trombo angiografico.

    Successo procedurale
    Nessun grave complicanze cliniche in ospedale (ad es. ISTH grave in corso o sanguinamento maggiore o cliniche pertinenti procedurale al momento della randomizzazione, ictus, CABG di emergenza).
    In sintesi, un successo di ICP clinico richiede sia successo anatomica sia procedurale insieme con sollievo di segni e/o sintomi di ischemia miocardica al momento della randomizzazione.

    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.
    Rischi di emorragia o condizioni sistemiche:
    1. Diatesi emorragica nota, compresa, ma non limitata a,
    a. Emorragia attiva incontrollata, che comprende sia le emorragie maggiori che quelle clinicamente rilevanti nonmaggiori secondo la definizione formulata dall’ISHT,
    rilevata al momento della randomizzazione;
    b. Lesione o condizione, se si considera che ciò costituisca un rischio significativo per emorragia maggiore;
    Ciò può comprendere, a titolo esemplificativo: ulcera
    gastrointestinale irrisolta, presenza di neoplasmi maligni ad
    elevato rischio emorragico (ad esempio, patologie maligne
    con metastasi), recenti lesioni cerebrali o spinali irrisolte,
    recenti episodi di chirurgia oftalmica, cerebrale o spinale,
    emorragie intracraniche di qualsiasi tipo, varici esofagee
    note o sospette, malformazioni arteriovenose, aneurismi
    vascolari (di dimensioni maggiori di 3,5 cm) o anormalità
    vascolari gravi intraspinali o intracerebrali.
    Connessi con l’utilizzo di medicinali:
    2. INR > 2,5 (il soggetto potrà essere preso nuovamente in
    considerazione in un momento successivo, ma entro 5 giorni dalla
    rimozione della guaina);
    3. Controindicazioni all’edoxaban, VKA, ASA e/o agli antagonisti del
    P2Y12;
    4. Trattamento concomitante con altri agenti antitrombotici, terapia
    fibrinolitica e assunzione di farmaci cronici anti-infiammatori non
    steroidei (NSAIDs).
    Condizioni e terapie concomitanti:
    5. Soggetti criticamente ammalati o emodinamicamente instabili (al
    momento della randomizzazione), ivi compresi:
    a. Shock cardiogeno o insufficienza cardiaca decompensata
    acuta, con la necessità dell’utilizzo di agenti vasosoppressori
    o sostegno inotropo o sostegno meccanico per
    coadiuvare la circolazione;
    b. Insufficienza respiratoria che richieda un’intubazione endotracheale
    e ventilazione meccanica.
    6. Qualsiasi episodio precedente di protesi valvolare meccanica;
    7. Un intervento di chirurgia coronarica o vascolare o un importante
    intervento chirurgico già pianificato entro 12 mesi; la
    randomizzazione dovrà essere rimandata all’ultimo step se si
    considera una procedura ICP multi-step, multivasale;
    8. Stenosi mitralica di grado moderato o severo;
    9. Ictus ischemico entro le 2 settimane precedenti la
    randomizzazione;
    10. Ipertensione severa, incontrollata con una pressione sanguigna
    sistolica (BP) _ 180 mmHg e/o pressione sanguigna diastolica BP
    _ 120 mmHg;
    11. Severa insufficienza renale con una stimata eliminazione della
    creatinina (CrCL) < 15 mL/min o trattamento di dialisi;
    12. Nota funzionalità epatica anormale prima della randomizzazione
    (ivi comprese patologie epatiche o evidenza biochimica di un
    significativo disordine epatico noto prima della randomizzazione)
    (si veda l’appendice 17.4).
    Altri criteri di esclusione:
    13. Presenza di uno qualsiasi fra i seguenti risultati di laboratorio
    locale anormali prima della randomizzazione:
    a. Conta piastrinica < 50 x 109/L
    b. Emoglobina < 8 mg/dL
    14. Impossibilità di fornire il proprio Consenso Informato (CI);
    15. Soggetto di sesso femminile potenzialmente fertile, che non
    utilizzi un adeguato metodo contraccettivo (per soggetto di sesso
    femminile potenzialmente fertile si intende una paziente che non
    sia entrata in menopausa da almeno un anno o che non sia stata
    sterilizzata chirurgicamente o che non si sia sottoposta a
    isterectomia almeno tre mesi prima dell’inizio di tale studio.) I
    soggetti di sesso femminile che assumono contraccettivi orali
    devono essere sotto tale terapia da almeno tre mesi. I
    contraccettivi adeguati comprendono dispositivi intra-uterini a
    rilascio ormonale, contraccettivi ormonali (orali, impiantabili,
    cerotto contraccettivo o iniettabili) e metodi doppia barriera come
    il preservativo o il diaframma con gel o schiuma spermicida.
    16. Soggetti in stato di gravidanza o che stanno allattando;
    17. Valutazione che ha determinato l’incapacità del soggetto di
    potersi confare alle procedure della sperimentazione o di poter
    effettuare un follow-up completo;
    18. Soggetto che partecipi ad un’altra sperimentazione che
    interferisce potenzialmente con la presente;
    19. Precedente randomizzazione nella presente sperimentazione;
    20. Nota dipendenza da alcool o farmaci nei 12 mesi precedenti,
    come valutato dallo Sperimentatore;
    21. Aspettativa di vita inferiore ai 12 mesi.
    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.
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First occurrence of any component.
    First occurrence of any component.
    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.
    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.
    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.
    All secondary endpoints are analyzed as time to first occurrence of any
    of its 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 concerned22
    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 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
    Austria
    Belgium
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Democratic People's Republic of
    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
    LPLV
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    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.1.2.1Number 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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state184
    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
    None
    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 Decision2017-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
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