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    Summary
    EudraCT Number:2016-003398-16
    Sponsor's Protocol Code Number:6396
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-11-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-003398-16
    A.3Full title of the trial
    Study of the benefit / risk ratio of oral anticoagulation in hemodialysis patients with atrial fibrillation
    Etude du rapport bénéfices / risques de l'anticoagulation orale chez les patients hémodialysés atteints de fibrillation auriculaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the benefit / risk ratio of oral anticoagulation in hemodialysis patients with atrial fibrillation
    Etude du rapport bénéfices / risques de l'anticoagulation orale chez les patients hémodialysés atteints de fibrillation auriculaire
    A.3.2Name or abbreviated title of the trial where available
    AVKDIAL
    AVKDIAL
    A.4.1Sponsor's protocol code number6396
    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 SponsorLes Hôpitaux Universitaires de Strasbourg
    B.1.3.4CountryFrance
    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 supportLes Hôpitaux universitaires de Strasbourg
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLes Hôpitaux Universitaires de Strasbourg
    B.5.2Functional name of contact pointDimitri Sanchez
    B.5.3 Address:
    B.5.3.1Street Address1,place de l'hôpital
    B.5.3.2Town/ cityStrasbourg
    B.5.3.3Post code67091
    B.5.3.4CountryFrance
    B.5.4Telephone number0033388115266
    B.5.5Fax number0033388115240
    B.5.6E-maildrci@chru-strasbourg.fr
    D. IMP Identification
    D.IMP: 1
    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 nameWarfarine sodique
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWARFARIN
    D.3.9.1CAS number 81-81-2
    D.3.9.3Other descriptive nameWARFARIN SODIUM
    D.3.9.4EV Substance CodeSUB05128MIG
    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 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 Information not present in EudraCT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluindione
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUINDIONE
    D.3.9.1CAS number 957-56-2
    D.3.9.4EV Substance CodeSUB07692MIG
    D.3.11 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 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 nameAcenocoumarol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACENOCOUMAROL
    D.3.9.1CAS number 152-72-7
    D.3.9.4EV Substance CodeSUB05211MIG
    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
    - Renal failure with dialysis
    - atrial fibrillation
    - Insuffisance rénale avec dialyse
    - fibrillation auriculaire
    E.1.1.1Medical condition in easily understood language
    To compare the combined risks of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in haemodialysis patients with atrial fibrillation
    Comparer les risques combinés de saignement grave et d’accident vasculaire cérébral de deux stratégies d'anticoagulation orale chez les patients hémodialysés atteints de fibrillation auriculaire
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the combined risks of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in haemodialysis patients with atrial fibrillation
    Comparer les risques combinés, de saignements graves et de thrombose, de l'anticoagulation orale par rapport à aucune anticoagulation chez des patients hémodialysés souffrant de fibrillation auriculaire
    E.2.2Secondary objectives of the trial
    To compare oral anticoagulation to no anticoagulation in haemodialysis patients with atrial fibrillation, regarding the risk of thrombosis and morbi-mortality
    Comparer le risque thrombotique et hémorragique indépendamment ainsi que la morbi-mortalité associée aux deux stratégies d'anticoagulation orale chez les patients hémodialysés atteints de fibrillation auriculaire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult patients (≥ 18 ans)
    -Patient on haemodialysis treatment for at least 1 month
    -Patient with an history of, or presenting a new episode of atrial fibrillation (either permanent or paroxystic).
    -Patient with a CHADS2VASC score ≥2
    -Patient with high risk of bleeding as defined by (1) HASBLED score ≥3 OR (2) HASBLED ≥ CHADS2VASC score, OR (3) recent history of severe bleeding (type 3a, 3b, 3c), particularly cerebral or gastrointestinal, OR (4) prior recurrent (>2) history of falls.
    -Patient capable of understanding information about the study and of giving his/her consent
    -Patient informed of the preliminary medical exam results
    -Patient with healthcare insurance
    -Written consent signed
    -Hommes et femmes majeurs affiliés à un régime de protection sociale
    -Patient informé des résultats préliminaires de l'examen médical
    -Sujet ayant signé un consentement éclairé
    -Patient en hémodialyse depuis au moins 1 mois
    -Patient avec un antécédent de fibrillation auriculaire ou avec une fibrillation auriculaire de novo, aussi bien permanente que paroxystique.
    -Patient avec un risque thrombotique défini par un score CHADS2VASC ≥2
    -Patient présentant un risque élevé de saignement tel que défini par (1) un score HASBLED ≥3 ou (2) score HASBLED ≥ CHADS2VASC, ou (3) une histoire récente d’hémorragies graves (type 3a, 3b, 3c), en particulier cérébrale ou gastro-intestinale, ou (4) des antécédents de chutes répétées (>2).
    -Contraception efficace durant toute la période d'étude pour les femmes en âge de procréer.
    E.4Principal exclusion criteria
    Formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome)
    -Life expectancy < 6 months (e.g., terminal cancer)
    -Live donor transplantation scheduled within 6 months
    -Pregnancy (β-HCG blood-based assay)or nursing (lactating) women
    -Women of child bearing potential, unless they are using an effective method of birth control
    -Patient under legal guardianship
    -Patients under law protection
    -Known hypersensibility to coumadin or indione derivatives or to any exipients (CI to oral AVK)
    -Severe liver failure (CI to oral AVK)
    Indication formelle à l'anticoagulation orale pour une autre pathologie que la fibrillation auriculaire (valve cardiaque mécanique, thrombophlébite récurrente, syndrome des antiphospholipides)
    -Espérance de vie < 6 mois (par exemple, cancer en phase terminale)
    -Transplantation de donneur vivant prévue dans les 6 mois
    -Femmes enceintes ou qui allaitent
    -Femmes en âge de procréer, à moins qu'elles utilisent une méthode efficace de contraception
    -Hypersensibilité connue à la coumadine ou aux dérivés de l’indione (Contre-indication aux AVK)
    -Insuffisance hépatique sévère (Contre-indication aux AVK)
    -Impossibilité de donner au sujet des informations éclairées (sujet en situation d’urgence, difficultés de compréhension…)
    -Sujet sous sauvegarde de justice
    -Sujet sous tutelle ou curatelle
    E.5 End points
    E.5.1Primary end point(s)
    Combined endpoint: Incidence of severe non-fatal (type 3a, 3b, 3c in the classification from the Bleeding Academic Research Consortium) (Mehran 2011) and fatal bleedings (type 5) plus Incidence of non-fatal and fatal strokes according to the therapeutic strategy, during 24 months.
    Critère combiné:
    Incidence des hémorragies graves non mortelles (type 3a, 3b, 3c dans la classification de la Bleeding Academic Research Consortium) (Mehran 2011), des hémorragies fatales (type 5) et des accidents vasculaires cérébraux non-fatals et mortels, en fonction de la stratégie thérapeutique
    E.5.1.1Timepoint(s) of evaluation of this end point
    During 24 months
    E.5.2Secondary end point(s)
    a) Incidence cumulée des évènements du critère d’évaluation principal.
    b) Incidence des hémorragies graves non mortelles (type 3a, 3b, 3c) en fonction de la stratégie thérapeutique
    c) Incidence des hémorragies fatales (type 5) en fonction de la stratégie thérapeutique
    d) Incidence des hémorragies graves non mortelles (type 3a, 3b, 3c) et des hémorragies fatales (type 5) en fonction de la stratégie thérapeutique
    e) Incidence des accidents vasculaires cérébraux non mortels en fonction de la stratégie thérapeutique
    f) Incidence des accidents vasculaires cérébraux mortels en fonction de la stratégie thérapeutique
    g) Incidence des accidents vasculaires cérébraux mortels et non mortels en fonction de la stratégie thérapeutique
    h) Incidence des hémorragies non mortelles et mortelles et des accidents vasculaires cérébraux mortels et non mortels en fonction de la stratégie thérapeutique
    i) Incidence des hémorragies fatales (type 5) et des accidents vasculaires cérébraux mortels en fonction de la stratégie thérapeutique
    j) Incidence des événements cardiovasculaires athérothrombotiques majeurs (MACE) en fonction de la stratégie thérapeutique
    k) L’incidence des événements athérothrombotique cardiovasculaires majeurs (MACE) et des décès cardiovasculaires en fonction de la stratégie thérapeutique
    l) Incidence de la mortalité toutes causes confondues selon la stratégie thérapeutique
    m) Validation formelle des scores de risques CHAD2VSAC et HASBLED chez les patients dialysés
    n) Comparaison des risques de la FA persistante ou permanente versus paroxystique
    o) Déclin cognitif en fonction de la stratégie thérapeutique
    –Cumulative incidence of events in the primary end point
    –Incidence of severe non-fatal (type 3a, 3b, 3c) bleedings according to the therapeutic strategy
    –Incidence of fatal bleedings (type 5) according to the therapeutic strategy
    –Incidence of severe non-fatal (type 3a, 3b, 3c) and fatal (type 5) bleedings according to the therapeutic strategy
    –Incidence of non-fatal strokes according to the therapeutic strategy
    –Incidence of fatal strokes according to the therapeutic strategy
    –Incidence of fatal and non-fatal strokes according to the therapeutic strategy
    –Incidence of non-fatal and fatal bleedings and fatal and non-fatal strokes according to the therapeutic strategy
    –Incidence of major atherothombotic cardiovascular events (MACE) according to the therapeutic strategy
    –Incidence of major atherothombotic cardiovascular events (MACE) and cardiovascular deaths according to the therapeutic strategy
    –Incidence of all cause mortality according to the therapeutic strategy
    –Formal validation of CHAD2VSAC and HASBLED as risk scores in dialysis patients
    –Comparison of risks in persistent/permanent vs paroxystic AF
    –Cognitive assessment according to the therapeutic strategy
    E.5.2.1Timepoint(s) of evaluation of this end point
    During 24 months
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 concerned16
    E.8.5The trial involves multiple Member States No
    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 No
    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
    date of last visit of the last patient included
    Date de dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-08-10
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