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    Summary
    EudraCT Number:2017-001834-25
    Sponsor's Protocol Code Number:MASTERDAPT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-001834-25
    A.3Full title of the trial
    MAnagement of high bleeding risk patients post bioresorbable polymer
    coated STEnt implantation with an abbReviated versus prolonged DAPT
    regimen – MASTER DAPT
    Gestione dei pazienti ad alto rischio di sanguinamento dopo impianto di stent rivestito con polimero riassorbibile in trattamento con regime di Duplice Terapia Antiaggregante breve versus Duplice Terapia Antiaggregante prolungata
    MASTER DAPT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To compare the duratin of double antiplatelets therapy after implant of new gereration medicated stent
    Confronto della durata della duplice terapia antipiastrinica dopo impianto di stent medicato di ultima generazione
    A.3.2Name or abbreviated title of the trial where available
    MASTER DAPT
    MASTER DAPT
    A.4.1Sponsor's protocol code numberMASTERDAPT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03023020
    A.5.4Other Identifiers
    Name:MASTER DAPTNumber:MASTER DAPT
    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 SponsorECRI-9
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTERUMO EUROPE NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInsel Bern University Hospital-Department of Cardiology
    B.5.2Functional name of contact pointProf. Marco Valgimigli
    B.5.3 Address:
    B.5.3.1Street AddressFreiburgstrasse
    B.5.3.2Town/ cityBerna
    B.5.3.3Post codeCH3010
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41316324714
    B.5.5Fax number+41316324736
    B.5.6E-mailmarco.valgimigli@insel.ch
    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 CARDIOASPIRIN - 100 MG COMPRESSE GASTRORESISTENTI30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCardioaspirin
    D.3.2Product code [024840]
    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 INNACIDO ACETILSALICILICO
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor codeACIDO ACETILSALICILICO
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    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: 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 PLAVIX - 75 28 COMPRESSE FILMRIVESTITE 75 MG IN BLISTER
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PHARMA BRISTOL-MYERS SQUIBB SNC
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.2Product code [034128]
    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 INNCLOPIDOGREL
    D.3.9.1CAS number 113665-84-2
    D.3.9.2Current sponsor codeCLOPIDOGREL
    D.3.9.3Other descriptive nameCLOPIDOGREL
    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: 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 EFIENT - 10MG - COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (ALL) 30X1 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.2Product code [039055]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.2Current sponsor codePRASUGREL
    D.3.9.3Other descriptive namePRASUGREL
    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: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 56 COMPRESSE (CONF. CALENDARIZZATA)
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA AB
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTicagrelor
    D.3.2Product code [040546]
    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 INNTICAGRELOR
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeTICAGRELOR
    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.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
    Coronary artery diseases
    Cardiopatia ischemica
    E.1.1.1Medical condition in easily understood language
    Heart artery disease
    Malattia dei vasi del cuore
    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 LLT
    E.1.2Classification code 10055218
    E.1.2Term Ischemic heart disease
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective is to compare, within current guidelines (GL) and instructions for use
    (IFU), an abbreviated versus a prolonged DAPT duration after bioresorbable polymer
    coated Ultimaster sirolimus-eluting stent implantation in patients presenting HBR
    features.
    Confrontare, nel rispetto delle attuali linee guida e istruzioni per l’uso, la durata breve del trattamento con DAPT versus la durata prolungata dopo impianto di stent Ultimaster a rilascio di sirolimus rivestito con polimero riassorbibile in pazienti ad alto rischio di sanguinamento.
    E.2.2Secondary objectives of the trial
    Not Applicable
    Non Applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria after index PCI
    After index PCI, patients aged 18 years or more are eligible for inclusion into the
    study if the following criteria are met.
    1) At least one among the HBR criteria (as defined below) is met.
    2) All lesions are successfully treated with Ultimaster stent in the context of
    routine clinical care, i.e. post-procedural angiographic diameter stenosis
    <20% by visual estimation
    3) Free from any flow-limiting angiographic complications (i.e. significant
    untreated dissection or major side-branch occlusion), which require prolonged
    DAPT duration based on operator’s opinion.
    4) All stages of PCI are complete (if any) and no further PCI is planned.
    Inclusion criteria at one-month randomization visit
    At randomization visit (one month after index PCI), the following criteria must be
    met:
    1) Fulfilment of at least one HBR criterion (as defined below), or on the basis of
    post-PCI actionable (i.e. requiring medical attention) non-access site related
    bleeding episode
    2) Uneventful 30-day clinical course, i.e. free from spontaneous MI,
    symptomatic restenosis, stent thrombosis, stroke and any revascularization
    (coronary and non-coronary) requiring prolonged DAPT
    3) If not on OAC,
    a. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
    b. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no
    switching between oral P2Y12 inhibitors has occurred in the previous
    7 days)
    4) If on OAC
    a. Patient is on the same type of OAC (e.g. Vitamin K antagonist or
    NOAC) for at least 7 days
    b. Patient is on clopidogrel for at least 7 days
    Definition of HBR
    Post-PCI patients are at HBR if at least one of the following criteria applies:
    ¿ Clinical indication for treatment with oral anticoagulants (OAC) for at least 12
    months
    ¿ Recent (<12 months) non-access site bleeding episode(s), which required
    medical attention (i.e. actionable bleeding).
    ¿ Previous bleeding episode(s) which required hospitalization if the underlying
    cause has not been definitively treated (i.e. surgical removal of the bleeding
    source)
    ¿ Age equal or greater than 75 years
    ¿ Systemic conditions associated with an increased bleeding risk (e.g.
    haematological disorders, including a history of or current thrombocytopaenia
    defined as a platelet count <100,000/mm3 (<100 x 109/L), or any known
    coagulation disorder associated with increased bleeding risk.
    ¿ Documented anaemia defined as repeated haemoglobin levels <11 g/dl or
    transfusion within 4 weeks before inclusion.
    ¿ Need for chronic treatment with steroids or non-steroidal anti-inflammatory
    drugs
    ¿ Diagnosed malignancy (other than skin) considered at high bleeding risk
    including gastro-intestinal, genito-urethral/renal and pulmonary.
    ¿ Stroke at any time or TIA in the previous 6 months
    ¿ PRECISE DAPT score of 25 or greater
    Criteri di inclusione dopo PCI index
    Dopo PCI index, i pazienti di età superiore e/o uguale a 18 anni, possono essere inclusi nello studio se vengono soddisfatti i seguenti criteri:
    1) Almeno uno dei criteri HBR (come definiti di seguito) è soddisfatto.
    2) Tutte le lesioni sono state trattate con successo con stent Ultimaster come da pratica clinica, (ad esempio risultato di stenosi residua di diametro < 20% valutato visivamente)
    3) Assenza di complicanze angiografiche che limitino il flusso (ad es. dissezioni significative non trattate o occlusione di un side-branch maggiore) che secondo l’opinione dell’operatore richiedano una DAPT prolungata.
    4) Completamento di tutte le eventuali PCI staged (se previste) e nessuna ulteriore PCI programmata.
    Criteri di inclusione alla visita di randomizzazione (follow-up a 1 mese)
    Alla visita di randomizzazione (un mese dopo PCI index), devono essere soddisfatti i seguenti criteri:
    1) Presenza di almeno uno dei criteri HBR (come definiti di seguito) o episodio di sanguinamento post-PCI non correlato al sito di accesso che richiede l’attenzione del medico
    2) Decorso clinico privo di eventi cardiovascolari a 30 giorni come assenza di: infarto miocardico, ristenosi sintomatica, trombosi dello stent, ictus e rivascolarizzazione (coronarica e non coronarica) che richieda un prolungamento della DAPT
    3) Se non trattati con anticoagulanti orali:
    a. Pazienti in regime DAPT con aspirina e con un inibitore P2Y12
    b. Pazienti trattati con lo stesso inibitore P2Y12 per almeno7 giorni prima della randomizzazione
    4) Se trattati con Anticoagulanti orali:
    a. Pazienti in terapia con lo stesso tipo di anticoagulante (ad es. antagonista della vitamina K o NOAC) per almeno 7 giorni prima della randomizzazione
    b. Pazienti in terapia con clopidogrel per almeno 7 giorni prima della randomizzazione
    Definizione dei criteri di HBR
    I pazienti post-PCI sono ad alto rischio di sanguinamento se si verifica almeno una delle seguenti condizioni:
    • Indicazione clinica al trattamento con anticoagulanti orali per almeno 12 mesi
    • Recente/i episodio/i (< 12 mesi) di sanguinamento non legato al sito di accesso che abbia/abbiano richiesto l’attenzione del medico
    • Precedente/i episodio/i di sanguinamento che abbia/abbiano richiesto il ricovero senza risoluzione definitiva della causa del sanguinamento
    • Età uguale o superiore a 75 anni
    • Condizioni sistemiche associate a un aumento del rischio di sanguinamento, ad es. malattie del sangue, tra cui episodi di trombocitopenia caratterizzati da una conta piastrinica < 100.000/mm3 (< 100 x 109/L), o altri disturbi della coagulazione associati a rischio di emorragie
    • Anemia documentata definita da ripetuti livelli di emoglobina < 11 g/dl o trasfusioni entro le 4 settimane precedenti l’inclusione.
    • Necessità di trattamento cronico a base di farmaci anti-infiammatori steroidei e non steroidei
    • Diagnosi di tumore maligno (non cutaneo) ad alto rischio di sanguinamento compresi tumori gastrointestinali, genitouretrali/renali e polmonari.
    • Stroke
    • TIA nei precedenti 6 mesi
    • Valore del PRECISE DAPT pari o maggiore a 25

    E.4Principal exclusion criteria
    Patients are not eligible if any of the following applies
    1) Treated with stents other than Ultimaster stent within 6 months prior to index
    procedure
    2) Treated for in-stent restenosis or stent thrombosis at index PCI or within 6
    months before
    3) Treated with a bioresorbable scaffold at any time prior to index procedure
    4) Cannot provide written informed consent
    5) Under judicial protection, tutorship or curatorship
    6) Unable to understand and follow study-related instructions or unable to
    comply with study protocol
    7) Active bleeding requiring medical attention (BARC=2) on randomization visit
    8) Life expectancy less than one year
    9) Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor,
    prasugrel, cobalt chromium or sirolimus
    10) Any planned and anticipated PCI
    11) Participation in another trial
    12) Pregnant or breast feeding women
    I pazienti per i quali si verifica una delle seguenti condizioni non sono ammessi allo studio
    1) Pazienti trattati con stent diversi dall’Ultimaster nei 6 mesi precedenti la procedura index
    2) Pazienti trattati per ristenosi dello stent o trombosi dello stent durante la procedura index o nei 6 mesi precedenti
    3) Pazienti trattati precedentemente con scaffold riassorbibile
    4) Pazienti non in grado di fornire il consenso informato scritto
    5) Pazienti che siano stati privati della propria libertà a seguito di provvedimenti amministrativi o legali o che siano sotto tutela giudiziaria
    6) Soggetti non in grado di comprendere e seguire le procedure dello studio o non in grado di aderire al protocollo di studio
    7) Sanguinamento in corso durante la visita di randomizzazione che richieda l’attenzione del medico (BARC = 2)
    8) Aspettativa di vita inferiore a un anno
    9) Ipersensibilità nota o allergia ad uno dei seguenti farmaci: aspirina, clopidogrel, ticagrelor, prasugrel, cromo cobalto o sirolimus
    10) PCI programmate o previste
    11) Partecipazione a un altro studio clinico
    12) Donne in gravidanza o in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    This study has 3 primary endpoints:
    1) Net adverse clinical endpoints (NACE) defined as a composite of all-cause
    death, myocardial infarction, stroke and bleeding events defined as BARC 3 or
    5
    2) Major adverse cardiac and cerebral events (MACCE) defined as a composite
    of all-cause death, myocardial infarction and stroke
    3) Major or clinically relevant non-major bleeding (MCB) defined as a composite
    of type 2, 3 and 5 BARC bleeding events
    1) NACE, definito come endpoint composito di tutte le cause di morte , infarto miocardico, stroke e sanguinamenti classificati secondo BARC 3 o 5
    2) MACCE definiti come endpoint composito di tutte le cause di morte, infarto miocardico e stroke
    3) MCB definito come endpoint composito di eventi emorragici BARC 2, 3 e 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    11 months
    11 mesi
    E.5.2Secondary end point(s)
    The individual components of each composite primary endpoints
    2) The composite of cardiovascular death, MI, and stroke
    3) The composite of cardiovascular death, MI, and any revascularization
    4) Death from cardiovascular causes
    5) The composite of definite or probable stent thrombosis
    6) Myocardial infarction
    7) Any target vessel revascularization
    8) Urgent target vessel revascularization
    Urgent non-target vessel revascularization
    10) Clinically indicated non-target vessel revascularization
    11) Bleeding events according to the BARC, TIMI and GUSTO classification
    12) Transfusion rates both in patients with and/or without clinically detected overt
    bleeding
    1) Componenti individuali di ciascun endpoint primario composito
    2) Composito di morte cardiovascolare, infarto miocardico e stroke
    3) Composito di morte cardiovascolare, infarto miocardico ed eventuale rivascolarizzazione
    4) Morte per cause cardiovascolari
    5) Composito di trombosi dello stent definita o probabile
    6) Infarto miocardico
    7) Qualsiasi rivascolarizzazione del vaso target
    8) Urgente rivascolarizzazione del vaso target
    9) Urgente rivascolarizzazione di vaso non target
    10) Indicazione clinica di rivascolarizzazione di vaso non target
    11) Sanguinamenti secondo le classificazioni BARC, TIMI e GUSTO
    12) Trasfusioni in pazienti con e/o senza sanguinamenti manifesti
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 months
    15 mesi
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Regime DAPT abbreviato
    Short DAPT regimen
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Regime DAPT prolungato
    Long DAPT regimen
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Germany
    Greece
    Hong Kong
    Indonesia
    Ireland
    Israel
    Italy
    Japan
    Latvia
    Netherlands
    Romania
    Singapore
    Spain
    Switzerland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    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 months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero 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: 430
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3870
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state850
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2800
    F.4.2.2In the whole clinical trial 4300
    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)
    At the end of the clinical trial the antiplatelet therapy is at the discretion of treating physician.
    Al termine della sperimentazione i pazienti seguiranno le indicazioni del medico curante circa la terapia antipiastrinica
    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 Decision2017-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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