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    Summary
    EudraCT Number:2012-001491-11
    Sponsor's Protocol Code Number:RIVAROXAFL3003
    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:2013-03-12
    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 number2012-001491-11
    A.3Full title of the trial
    An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention - PIONEER AF-PCI
    Uno studio multicentrico, controllato, randomizzato, in aperto che esplora due strategie di trattamento di rivaroxaban e una dose regolata di antagonista della vitamina K orale in soggetti con fibrillazione atriale sottoposti a intervento coronarico percutaneo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the Safety of Rivaroxaban in adult subjects with irregular heart rhythm beat (called atrial fibrillation) and a stent placed in heart artery.
    Valutazione della sicurezza di Rivaroxaban in soggetti adulti con ritmo cardiaco irregolare (fibrillazione atriale) e stent.
    A.3.2Name or abbreviated title of the trial where available
    PIONEER AF-PCI
    PIONEER AF-PCI
    A.4.1Sponsor's protocol code numberRIVAROXAFL3003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/134/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Scientific Affairs
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Scientific Affairs
    B.5.2Functional name of contact pointPeter Wildgoose
    B.5.3 Address:
    B.5.3.1Street Address1000 US Route 202
    B.5.3.2Town/ cityRaritan, NJ
    B.5.3.3Post code08869
    B.5.3.4CountryUnited States
    B.5.4Telephone number011908927 6803
    B.5.6E-mailpwildgoo@its.jnj.com
    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 Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameRivaroxaban
    D.3.2Product code BAY 59-7939 (JNJ-39039039)
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY 59-7939
    D.3.9.4EV Substance CodeSUB29263
    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 Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameRivaroxaban
    D.3.2Product code BAY 59-7939 (JNJ-39039039)
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY 59-7939
    D.3.9.4EV Substance CodeSUB29263
    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: 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRivaroxaban
    D.3.2Product code BAY 59-7939 (JNJ-39039039)
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY 59-7939
    D.3.9.4EV Substance CodeSUB29263
    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.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.2.5The 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 nameA vitamin K antagonist (VKA) used according to standard of care
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention
    Pazienti con fibrillazione atriale sottoposti a intervento coronarico percutaneo
    E.1.1.1Medical condition in easily understood language
    Nonvalvular atrial fibrillation patients who undergo percutaneous coronary intervention procedure
    Pazienti con fibrillazione atriale sottoposti a intervento coronarico percutaneo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 of this study is to assess the safety of 2 rivaroxaban treatment strategies and a dose-adjusted VKA treatment strategy after PCI (with stent placement) in subjects with paroxysmal, persistent, or permanent non-valvular AF, based on the composite of TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events (known collectively as
    clinically significant bleeding) after 12 months of therapy.
    L'obiettivo primario di questo studio è determinare la sicurezza di 2 strategie di trattamento con rivaroxaban e una strategia di trattamento con una dose regolata di antagonista della vitamina K (VKA)dopo PCI (con impianto di stent) in soggetti con FA non valvolare parossistica, persistente o permanente, sulla base dell'insieme composito di eventi (noti comunemente come sanguinamento clinicamente significativo) di sanguinamento maggiore, sanguinamento minore e sanguinamento che richieda attenzione medica secondo la scala TIMI (trombolisi nell'infarto miocardico) dopo 12 mesi di terapia.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to explore the differences between the treatment strategy groups in
    terms of:
     TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events
     the composite and each component of adverse cardiovascular events (cardiovascular death,
    MI, and stroke)
     stent thrombosis events
     TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events, and
    the composite and each component of adverse cardiovascular events (cardiovascular death,
    MI, stroke) at the end of intended DAPT period
    Gli obiettivi secondari intendono indagare le differenze tra i gruppi di trattamento in termini di:
    • sanguinamento maggiore, sanguinamento minore e sanguinamento che richieda attenzione medica secondo la scala TIMI (trombolisi nell'infarto miocardico).
    • l'insieme composito e ciascun componente degli eventi cardiovascolari avversi (morte cardiovascolare, infarto miocardico [IM], e ictus).
    • Eventi trombotici dello stent.
    • sanguinamento maggiore, sanguinamento minore e sanguinamento che richieda attenzione medica secondo la scala TIMI e l'insieme composito e ogni componente degli eventi avversi cardiovascolari ( morte cardiovascolare, IM e ictus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Have a documented medical history of paroxysmal, persistent, or permanent non-valvular AF
    Have undergone PCI procedure (with stent placement) for primary atherosclerotic disease
    Be willing and able to adhere to the prohibitions and restrictions specified in this protocol
    Per essere arruolato nello studio, ciascun soggetto potenziale deve soddisfare tutti i criteri elencati di seguito. Ciascun soggetto deve:
    1. Essere un uomo o una donna di età ≥18 anni.
    2. Criterio modificato per emendamento
    2.1. Presentare una documentata storia medica di FA non valvolare parossistica, persistente o permanente (definita come FA non considerata essere causata da una stenosi della valvola primaria); vedi Sezione 17.4 del protocollo.
    3. Essere stato sottoposto a procedura di PCI (con impianto di stent) per malattia aterosclerotica primaria
    4. I soggetti di sesso femminile, prima dell'ingresso nello studio, devono essere:
    • essere in stato post-menopausale, definito come:
    - età > 45 anni con amenorrea da almeno 18 mesi, oppure
    • Se ancora in età fertile, devono:
    - essere chirurgicamente sterili (sottoposte a isterectomia o ad ooforectomia bilaterale, legatura delle tube o non considerate fertili), oppure
    - se eterosessualmente attive, adottare un metodo contraccettivo altamente efficace, inclusi contraccettivi ormonali orali su prescrizione, iniezioni contraccettive, cerotto contraccettivo, dispositivo intrauterino, metodo a doppia barriera (cioè preservativi, diaframma o cappuccio cervicale, con schiuma, crema o gel spermicida) oppure sterilizzazione del partner maschile, in linea con le normative locali sull'impiego di metodi contraccettivi per i soggetti partecipanti a sperimentazioni cliniche, per la durata della loro partecipazione allo studio, oppure
    - non essere eterosessualmente attive.
    Nota: le donne che non sono eterosessualmente attive allo screening devono concordare sull'impiego di un metodo contraccettivo altamente efficace qualora diventino eterosessualmente attive durante la loro partecipazione allo studio.
    Le donne devono impegnarsi a continuare a utilizzare i suddetti metodi contraccettivi per l'intera durata dello studio.
    5. Le donne in età fertile devono presentare un test di gravidanza sulle urine della gonadotropina corionica umana P (PhCG) negativo allo screening. Il test di gravidanza in siero può essere eseguito qualora richiesto dal regolamento locale.
    6. Volontà e capacità di conformarsi ai divieti e alle restrizioni specificati in questo protocollo
    7. Firmare un modulo di consenso informato indicante che il soggetto ha compreso lo scopo dello studio e le relative procedure e che intende prendervi parte.
    E.4Principal exclusion criteria
    • Has any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count <90,000/μL at screening; history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated PT at screening
    • Has anemia of unknown cause with a hemoglobin level <10 g/dL (<6.21 mmol/L)
    • Has a history of stroke or TIA
    • Has calculated CrCl <30 mL/min at screening or prerandomization
    • Has known significant liver disease or liver function test (LFT) abnormalities
    • Has any severe condition that would limit life expectancy to less than 12 months
    •1. Rischi di sanguinamento: qualsiasi condizione che, nell’opinione dello sperimentatore, controindichi una terapia anticoagulante o avrebbe un rischio inaccettabile di sanguinamento
    Patologie severe concomitanti
    2. Presenta una storia di ictus o TIA
    3. Presenta shock cardiogeno al momento della randomizzazione
    4. Presenta aritmie ventricolari refrattarie al trattamento al momento della randomizzazione
    5. Presenta CrCl calcolata <30 mL/min allo screening o alla prerandomizzazione
    6. Ha una nota malattia epatica significativa (ad es., epatite acuta, epatite cronica attiva, cirrosi), oppure anomalie del test di funzionalità epatica (LFT) allo screening (confermate dalla ripetizione del test): alanina transaminasi (ALT) >5 volte il limite superiore della norma o ALT >3 volte il limite superiore della norma più bilirubina totale >2 volte il limite superiore della norma
    7. Criterio modificato per emendamento
    7.1. Presenta anemia di causa ignota con un livello di emoglobina <10g/dL (<6,21 mmol/L) allo screening o alla prerandomizzazione.
    8. Presenta una storia clinica nota di infezione da virus della immunodeficienza umana (HIV)
    9. Presenta un attuale problema di abuso di sostanze (droghe o alcool) oppure una storia dello stesso problema nei 6 mesi precedenti
    10. Presenta una qualsiasi condizione severa che limiterebbe le aspettative di vita a meno di 12 mesi
    Generale:
    11. È stato sottoposto a intervento chirurgico maggiore, a biopsia di un organo parenchimale o ha subito un serio trauma (incluso trauma cranico) nei 30 precedenti.
    12. Criterio modificato per emendamento
    12.1. Ha una sospettata o documentata trombosi dello stent durante la procedura di indicizzazione

    OPPURE

    Ha una procedura PCI con impianto di stent per una lesione precedentemente trattata con impianto di stent (stent all'interno di uno stent) durante la procedura di indicizzazione o nei 12 mesi precedenti
    13. Criterio modificato per emendamento
    13.1. Ha una procedura PCI con stadiazione incompleta (una volta che il completamento della procedura di stadiazione è avvenuto, il PCI finale può diventare l'evento di indicizzazione ed è consentito)
    14. Ha programmato un intervento chirurgico di bypass aorto-coronarico (CABG)
    15. Criterio modificato per emendamento
    15.1 criterio cancellato
    16. Criterio modificato per emendamento.
    16.1 Presenta controindicazioni per l'uso di VKA, ASA, o inibitori antipiastrinici P2Y12 (clopidogrel, prasugrel, o ticagrelor) in base alle informazioni di prescrizione.
    17. Criterio modificato per emendamento
    17.1. Presenta FA transitoria provocata da un disturbo reversibile (ad es., tireotossicosi, embolia polmonare, intervento chirurgico recente)
    18. Criterio modificato per emendamento
    18.1. Presenta condizione/i diversa/e da FA non valvolare parossistica, persistente o permanente che richiede/richiedono una terapia anticoagulante a lungo termine con VKA durante la conduzione dello studio, includendo ma senza limitarsi a stenosi della valvola mitrale da moderata a severa, valvole cardiache meccaniche, trombosi venosa profonda, embolia polmonare o trombo ventricolare sinistro
    19. Riceve un trattamento sistemico con forti inibitori sia del (CYP) 3A4 sia della P-glicoproteina (P-gp; ad es., l'azolo antimicotico chetoconazolo e l'inibitore della proteasi dell'HIV ritonavir). Il trattamento con l'azolo antimicotico fluconazolo è consentito.
    20. Presenta note allergie, ipersensibilità o intolleranza al rivaroxaban o ai suoi eccipienti (fare riferimento alla Brochure dello sperimentatore)
    21. Ricorre a terapie non consentite. Fare riferimento alla Sezione 8 del protocollo, Prestudio e Terapia Concomitante.
    22. Presenta una necessità anticipata di terapia cronica (più di 4 settimane) con farmaci antiinfiammatori non steroidei (FANS)
    23. Ha ricevuto un farmaco sperimentale (inclusi vaccini sperimentali) o ha utilizzato un dispositivo medico sperimentale invasivo entro 30 giorni precedenti alla prima dose programmata del farmaco dello studio oppure è attualmente arruolato in uno studio sperimentale.
    24. È una donna gravida o in fase di allattamento o che sta pianificando una gravidanza durante l'arruolamento nello studio
    25. Presenta una malignità attiva
    26. Presenta qualsiasi condizione che, secondo il giudizio dello sperimentatore, renderebbe la partecipazione non nel miglior interesse del soggetto (ad es., ne comprometterebbe il benessere) o potrebbe impedire, limitare o confondere le valutazioni specificate dal protocollo
    27. È un dipendente dello sperimentatore o del centro di sperimentazione direttamente coinvolto nello studio proposto o in altri studi sotto la direzione di detto sperimentatore o centro di sperimentazione oppure è un familiare di un dipendente o dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoint for this study is the occurrence of the composite of TIMI major bleeding, minor bleeding, and bleeding requiring medical attention events (known collectively as clinically significant bleeding)
    L'endpoint di sicurezza primaria per questo studio è la proporzione di pazienti con insieme composito di eventi (noti comunemente come sanguinamento clinicamente significativo) di sanguinamento maggiore, sanguinamento minore e sanguinamento che richieda attenzione medica secondo la scala TIMI al termine del
    mese 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Percutaneous Coronary Intervention procedure to Month 12.
    Dalla Procedura di intervento coronarico percutaneo al Mese 12
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are the proportions of subjects at the end of DAPT and at
    Month 12 with the following events:
    · Each component of the TIMI clinically significant bleeding composite (TIMI major
    bleeding, minor bleeding, and bleeding requiring medical attention)
    · The composite of adverse cardiovascular events (cardiovascular death, MI, and stroke)
    · Cardiovascular death
    · Myocardial infarction
    · Stroke
    · Stent thrombosis
    Gli endpoint secondari per questo studio al termine della terapia con DAPT ed al mese 12 è la proporzione di pazienti con i seguenti eventi:
    • Ciascun componente dell'insieme composito di sanguinamenti significativi clinicamente secondo la scala TIMI (sanguinamento maggiore, sanguinamento minore e sanguinamento che richieda attenzione medica secondo la scala TIMI)
    • L’insieme composito di eventi cardiovascolari avversi (morte cardiovascolare, IM e ictus
    • morte cardiovascolare
    • infarto miocardico
    • ictus
    • trombosi dello stent
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Percutaneous Coronary Intervention procedure to the end of DAPT period (by prespecified duration of 1, 6, or 12 months) and at Month 12.
    Dalla Procedura di intervento coronarico percutaneo alla fine della terapia DAPT e al Mese 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vitamin K Antagonist (VKA)
    E.8.2.4Number of treatment arms in the trial3
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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
    Argentina
    Belgium
    Canada
    Chile
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Russian Federation
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 1320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 780
    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 state97
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1078
    F.4.2.2In the whole clinical trial 2109
    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
    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 Decision2013-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
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