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    Summary
    EudraCT Number:2015-004847-37
    Sponsor's Protocol Code Number:EDO-SP-01-2015
    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:2021-06-08
    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 number2015-004847-37
    A.3Full title of the trial
    A pilot study on Edoxaban for the resolution of left atrial thrombosis in patients with non-valvular atrial fibrillation
    Studio pilota su edoxaban per la risoluzione della trombosi atriale sinistra in pazienti con fibrillazione atriale non valvolare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study on Edoxaban for the resolution of left atrial thrombosis in patients with non-valvular atrial fibrillation
    Studio pilota su edoxaban per la risoluzione della trombosi atriale sinistra in pazienti con fibrillazione atriale non valvolare
    A.3.2Name or abbreviated title of the trial where available
    Edoxaban in AF
    Edoxaban in AF
    A.4.1Sponsor's protocol code numberEDO-SP-01-2015
    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 SponsorFONDAZIONE G. D'ANNUNZIO, CHIETI
    B.1.3.4CountryItaly
    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 supportDaiichi-Sankyo Italia S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale Clinicizzato SS Annunziata
    B.5.2Functional name of contact pointReparto di Cardiologia Universitari
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Vestini
    B.5.3.2Town/ cityChieti
    B.5.3.3Post code66013
    B.5.3.4CountryItaly
    B.5.4Telephone number08713556922
    B.5.5Fax number08713556922
    B.5.6E-mailgrenda@unich.it
    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
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi-Sankyo Europe GmbH
    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.3.4Pharmaceutical form Film-coated 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 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
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi-Sankyo Europe GmbH
    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.3.4Pharmaceutical form Film-coated 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 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
    Non-Valvular Atrial Fibrillation
    Fibrillazione Atriale Non Valvolare
    E.1.1.1Medical condition in easily understood language
    Non-Valvular Atrial Fibrillation
    Fibrillazione Atriale Non Valvolare
    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 10016566
    E.1.2Term Fibrillation atrial
    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 primary objective of the study will be the definition of the percentage of patients who, after 4 weeks of edoxaban treatment, will experience complete thrombus resolution by TEE.
    L¿obiettivo primario dello studio sar¿ la definizione della percentuale di pazienti che, dopo 4 settimane di trattamento con edoxaban, avranno riscontro al TEE della completa risoluzione del trombo.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be the assessment of bleeding events after 4 weeks of treatment with edoxaban and, after the same period, the incidence of any stroke or peripheral embolism and the time, when applicable, to electrical cardio-version.
    Gli obiettivi secondari saranno la valutazione di eventi emorragici dopo 4 settimane di trattamento con edoxaban e, dopo lo stesso periodo di trattamento, l¿incidenza di ictus o embolia sistemica e il tempo per la cardioversione elettrica (se applicabile).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with all the following criteria will be eligible for inclusion in the study protocol:
    1. Signed written informed consent.
    2. Males and females = 18 years of age.
    3. Female subjects must be post-menopausal (for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative serum ß-hCG pregnancy test at screening.
    4. Atrial fibrillation (AF) must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before enrolment.
    5. Subjects with newly diagnosed atrial fibrillation are eligible provided that:
    • -there is evidence that the atrial fibrillation is non-valvular:
    • -there is ECG evidence on 2 occasions 24 hours apart demonstrating atrial fibrillation.
    6. LA or LAA thrombosis documented by trans-esophageal echocardiography (TEE)
    7. CHA2DS2-VASC score >1.
    I pazienti che soddisfano tutti i seguenti criteri saranno eleggibili per l’inclusione nello studio:
    1. Pazienti che abbiano dato il loro consenso scritto per la partecipazione allo studio
    2. Adulti di ambo i sessi ed età maggiore ai 18 anni
    3. I pazienti di sesso femminile devono aver superato lo status di post-menopausa (da almeno due anni), essere sterili chirurgicamente, essere astinenti, o, se sessualmente attive, devono affidarsi ad un metodo contraccettivo efficace (es. contraccettivi orali, contraccettivi iniettabili, dispositivi intrauterini, metodi doppia-barriera, cerotti, sterilizzazione del partner) prima di essere arruolate e nel corso dello studio; e, per coloro le quali sia potenzialmente possibile una gravidanza, al momento dello screening, il test di gravidanza sul siero per ß-hCG deve risultare negativo.
    4. Fibrillazione atriale (FA) documentata tramite esame ECG nei 30 giorni precedenti l’arruolamento
    5. Soggetti con una nuova diagnosi di fibrillazione atriale sono eleggibili se è accertato che:
    ¿ C’è evidenza che la fibrillazione atriale è non valvolare
    ¿ La fibrillazione atriale è accertata tramite apposito ECG svolto in 2 occasioni a 24 ore di distanza
    6. Documentata trombosi in atrio o auricola sinistra con esame ecocardiografico transesofageo (TEE)
    7. Punteggio CHA2DS2-VASC >1.
    E.4Principal exclusion criteria
    Patients with all the following criteria will not be eligible for inclusion in the study protocol:
    1. Hemodynamically significant mitral valve stenosis.
    2. Prosthetic heart mechanical or biological valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted).
    3. Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery or myocardial infarction).
    4. Known presence of atrial myxoma.
    5. Left ventricular thrombus.
    6. Active endocarditis.
    7. Active internal bleeding.
    8. History of condition associated with increased bleeding risk including, but not limited to:
    • major surgical procedure or trauma within 30 days;
    • clinically significant gastrointestinal bleeding within 6 months;
    • previous intracranial, intraocular, spinal, atraumatic intra-articular bleeding;
    • chronic haemorrhagic disorder;
    • Any neoplasm, including intracranial neoplasm,
    • arteriovenous malformation or aneurysm.
    9. Platelet count <90,000/µL at the screening visit.
    10. Sustained uncontrolled hypertension: SBP =180 mmHg or DBP =100 mmHg.
    11. Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive within 3 months or any stroke < 14 days).
    12. Transient ischemic attack within 3 days.
    13. Treatment with:
    • Any NAO or VKA with optimal INR (optimal = all INR values =2.0 in the previous 30 days)
    • aspirin >160 mg daily;
    • aspirin plus a thienopyridine within 5 days;
    • intravenous antiplatelets within 5 days;
    • fibrinolytics within 10 days.
    14. Anticipated need for therapy with a non-steroidal anti-inflammatory drug in the next 4 weeks.
    15. Treatment with a strong inducer of cytochrome P450 and P glycoprotein, such as ritonavir, lopinavir, telaprevir, indinavir or planned treatment during the study.
    16. Other indication for anticoagulant therapy.
    17. Hypersensitivity or intolerance to the study drug, including excipients.
    18. Women of childbearing potential who do not want adopt a contraceptive method during the study period and the following 4 weeks.
    19. Breast-feeding women during the study period and the following 4 weeks.
    20. Anemia (hemoglobin <10 g/dL) at the screening visit.
    21. Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or ALT or AST >2 x ULN or total bilirubin >1.5 x ULN.
    22. Patients with severe renal impairment (CrCL <30 mL/min) or on dialysis.
    I pazienti con uno dei seguenti criteri non sarà eleggibile per l’inclusione nello studio:
    1. Significativa stenosi mitralica
    2. Valvola cardiaca protesica, meccanica o biologica (annuloplastica con o senza anello protesico, commissurotomia e/o valvuloplastica sono consentiti)
    3. Fibrillazione atriale transitoria causata da un disturbo reversibile (ad esempio: tireotossicosi, embolia polmonare, recente intervento chirurgico o infarto del miocardio)
    4. Mixoma Atriale
    5. Trombo ventricolare sinistro
    6. Endocardite attiva
    7. Sanguinamento interno attivo
    8. Condizione pregressa associata ad un aumentato rischio di sanguinamento, ma non solo:
    - intervento chirurgico maggiore o trauma nei 30 giorni precedenti l’arruolamento;
    - significativo sanguinamento gastrointestinale nei 6 mesi precedenti l’arruolamento;
    - pregresso sanguinamento intracranico, intraoculare, spinale, intra-articolare atraumatico;
    - disturbo emorragico cronico;
    - qualsiasi neoplasia, inclusa neoplasia intracranica
    - malformazione arterovenosa o aneurisma
    9. Conta piastrinica <90.000/µL al momento della visita di sceening
    10. Ipertensione sostenuta e incontrollata: SBP =180 mmHg or DBP =100 mmHg
    11. Grave ictus invalidante (alterato punteggio di Rankin 4-5, compreso entro 3 mesi o ictus <14 giorni)
    12. Attacco ischemico transitorio nei 3 giorni precedenti l’arruolamento
    13. Trattamento con:
    - anticoagulanti orali o VKA con INR ottimale (ottimale = valore di INR = 2.0 nei precedenti 30 giorni)
    - aspirina> 160 mg al giorno
    - aspirina più tienopiridina nei 5 giorni precedenti l’arruolamento
    - antipiastrinici per via endovenosa nei 5 giorni precedenti l’arruolamento
    - fibrinolitici nei 10 giorni precedenti l’arruolamento
    14. Prevista necessità di terapia con un farmaco antinfiammatorio non steroideo durante le successive 4 settimane
    15. Trattamento con un forte induttore del citocromo P450 e della glicoproteina P come ritonavir, lopinavir, telaprevir, indinavir o trattamenti programmati durante lo studio
    16. Altra indicazione per la terapia anticoagulante
    17. Ipersensibilità o intolleranza al farmaco in studio o ai suoi eccipienti
    18. Donne che potenzialmente potrebbero rimanere incinta che non usano metodi contraccettivi durante il periodo di studio e per le successive 4 settimane
    19. Donne in stato di allattamento al seno durante il periodo di studio e per le successive 4 settimane
    20. Anemia (emoglobina <10 g /dL) alla visita di screening
    21. Significativa patologia epatica (ad esempio, epatite clinica acuta, epatite cronica attiva, cirrosi), o ALT o AST >2 x ULN o bilirubina totale >1.5 x ULN
    22. Pazienti con insufficienza renale grave (CrCL <30 mL/ min) o in dialisi.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study will be the definition of the percentage of patients who, after 4 weeks of edoxaban treatment, will experience complete thrombus resolution by TEE.
    L’obiettivo primario dello studio sarà la definizione della percentuale di pazienti che, dopo 4 settimane di trattamento con edoxaban, avranno riscontro al TEE della completa risoluzione del trombo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks/patient
    4 settimane per paziente
    E.5.2Secondary end point(s)
    Secondary objectives will be the assessment of bleeding events after 4 weeks of treatment with edoxaban and, after the same period, the incidence of any stroke or peripheral embolism and the time, when applicable, to electrical cardio-version.
    Gli obiettivi secondari saranno la valutazione di eventi emorragici dopo 4 settimane di trattamento con edoxaban e, dopo lo stesso periodo di trattamento, l¿incidenza di ictus o embolia sistemica e il tempo per la cardioversione elettrica (se applicabile).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks/patient
    4 settimane per paziente
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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)
    During the follow-up Visit (4 weeks) physician caring for the patient will decide which medication the patient should receives as part of his/her usual care.
    Durante la visita di follow-up (4 settimane) il medico valuter¿ la tipologia di trattamento che il paziente dovr¿ ricevere secondo la normale pratica clinica.
    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 Decision2017-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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