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    Summary
    EudraCT Number:2017-003342-25
    Sponsor's Protocol Code Number:P170604J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-04-03
    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 number2017-003342-25
    A.3Full title of the trial
    Long-term treatment of cancer associated VTE Optimal dose of apixaban API-CAT STUDY for APIxaban Cancer Associated Thrombosis
    Long-term treatment of cancer associated VTE Optimal dose of apixaban API-CAT STUDY for APIxaban Cancer Associated Thrombosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term treatment of cancer associated VTE: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis
    Efficacité et sécurité de l'emploi d'un anticoagulant oral, l'apixaban à dose réduite, dans le traitement prolongé de la maladie thromboembolique veineuse chez des patients atteints de cancer actif
    A.3.2Name or abbreviated title of the trial where available
    API-CAT
    A.4.1Sponsor's protocol code numberP170604J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportBristol Myers Squibb SARL
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailaurelie.zindjirdjian@aphp.fr
    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 ELIQUIS 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG
    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 nameELIQUIS 5mg
    D.3.4Pharmaceutical form 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 INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 ELIQUIS 2,5mg
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG
    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 nameELIQUIS 2,5mg
    D.3.4Pharmaceutical form 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 INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with breast, prostate, and colorectal active cancer, with objectively documented index event of symptomatic or incidental proximal DVT or symptomatic or incidental PE, after 6 months of anticoagulant therapy for the treatment of the index event, with no objectively documented symptomatic recurrence of VTE between the index event and randomization.
    Sujets ayant un cancer actif du sein, de la prostate ou colorectal, avec un ETEV index objectivement documenté de TVP proximale (symptomatique ou de découverte fortuite) ou EP (symptomatique ou de découverte fortuite) ayant reçu environ 6 mois de traitement anticoagulant sans interruption pour le traitement de l'ETEV index et n'ayant pas présenté de récidive symptomatique objectivement documentée d'ETEV au cours de cette période de 6 mois après diagnostic de l'ETEV index.
    E.1.1.1Medical condition in easily understood language
    Venous thrombosis or pulmonary embolism, with cancer
    Thrombose veineuse ou une embolie pulmonaire compliquant l'évolution de la maladie cancéreuse
    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 10076654
    E.1.2Term Cancer-associated thrombosis
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active breast, prostate or colorectal cancer who have completed 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (PE) (symptomatic or incidental).
    Déterminer si le schéma posologique d'apixaban à dose réduite (2,5 mg 2fois par jour) est non inférieur à un schéma posologique d'apixaban à pleine dose (5 mg 2fois par jour) dans la prévention du risque de récidive d'ETEV chez les patients atteints de cancer actif du sein, de la prostate ou colorectal qui ont reçu 6 mois de traitement anticoagulant sans interruption pour traiter un ETEV index documenté de thrombose veineuse profonde proximale (TVP) (symptomatique ou de découverte fortuite) ou embolie pulmonaire (EP (symptomatique ou de découverte fortuite).
    E.2.2Secondary objectives of the trial
    The key secondary objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is safer than a full dose regimen of apixaban (5 mg bid) in patients with active breast, prostate or colorectal cancer who have completed 6 months of anticoagulant therapy for treating a documented index event of proximal DVT (symptomatic or incidental) or PE (symptomatic or incidental).

    Other secondary objectives
    To compare treatment effects of the reduced apixaban doses relative to full dose for the following:
    o recurrent symptomatic VTE ;
    o VTE-related death ;
    o all-cause death ;
    o major bleeding.
    Déterminer si le schéma posologique d'apixaban à dose réduite (2,5 mg 2 fois par jour) est plus sûr qu'un schéma posologique d'apixaban à dose pleine (5 mg 2 fois par jour) chez les patients atteints de cancer du sein, de la prostate ou du cancer colorectal actif qui ont reçu 6 mois de traitement anticoagulant sans interruption pour traiter un ETEV index documenté de TVP proximale (symptomatique ou de découverte fortuite) ou EP (symptomatique ou de découverte fortuite).
    - Comparer les effets du traitement à dose diminuée par rapport à la dose complète en ce qui concerne:
    o récidive d'ETEV symptomatique ;
    o décès par ETEV ;
    o décès, toutes causes confondues ;
    o saignement majeur.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Written Informed Consent
    - Breast, prostate, colo-rectal cancer diagnosed histologically
    - Active cancer defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy, hormonotherapy or targeted therapy at inclusion.
    - Objectively documented index event of :
    symptomatic or incidental proximal lower-limb, iliac, inferior cava vena DVT or symptomatic or incidental PE in a segmental or larger pulmonary artery
    (1) Proximal DVT is defined as DVT that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography or contrast enhanced computed tomography or magnetic resonance imaging.
    (2) PE has to be demonstrated by imaging as follows:
    an intraluminal filling defect in segmental or more proximal branches on contrast enhanced chest computed tomography or on computed tomography pulmonary angiography ; or
    an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or
    a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
    (3) Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of his or her malignancy or other reasons but not for a VTE suspicion(e.g. cancer diagnosis or staging).

    - 6 months of anticoagulant therapy at therapeutic dosage (whatever the drug and the dosing), or completed assigned a clinical trial study treatment, for the treatment of the index event; and patient still receiving anticoagulant treatment 6 months after occurrence or the VTE index event.
    - No objectively documented symptomatic recurrence of VTE between the index event and randomization.
    - Anticipated duration of anticoagulant treatment of at least 12 months at the time of randomization.
    - Patient affiliated to social security for French centers.
    o Consentement écrit éclairé signé ;
    o Cancer du sein, de la prostate ou colorectal diagnostiqué histologiquement ;
    o Cancer actif défini par la présence d'une maladie mesurable ou d'une chimiothérapie, d'une radiothérapie, d'une hormonothérapie ou d'une thérapie ciblée en cours (ou prévue) à l'inclusion.
    o Événement index objectivement documenté de TVP des membres inférieurs proximale symptomatique ou de découverte fortuite, de TVP iliaque, de la veine cave inférieure ou d'EP symptomatique ou de découverte fortuite dans une artère pulmonaire segmentaire ou plus proximale.
    (1) La TVP proximale est définie comme une TVP qui implique au moins la veine poplitée ou une veine plus proximale, documentée par imagerie par échographie de compression, associé à un Doppler ou scanner injecté ou par imagerie par résonance magnétique.
    (2) L'EP doit être confirmée par imagerie comme suit:
    - un défaut de remplissage intraluminal dans les branches segmentaires ou plus proximales sur le scanner thoracique injecté ou l'angio-scanner pulmonaire ou
    - un défaut de remplissage intraluminal ou une interruption brutale d'un vaisseau de plus de 2,5 mm de diamètre sur l'angiographie pulmonaire ou
    - un défaut de perfusion d'au moins 75% d'un segment avec une scintigraphie de ventilation normale (haute probabilité) sur la scintigraphie de ventilation / perfusion pulmonaire (VPLS).
    (3) L'ETEV de découverte fortuite est définie comme une TVP proximale ou une EP détectée par imagerie de manière fortuite alors que le patient réalise un acte d'imagerie dans le cadre du suivi classique en soins courant pour la prise en charge de son cancer ou d'autres raisons, mais pas pour une suspicion d'ETEV (p. ex. diagnostic ou bilan d'évaluation du cancer).
    o 6 mois de traitement anticoagulant sans interruption à la dose thérapeutique (quel que soit le traitement anticoagulant et la dose), ou traitement anti coagulant dans le cadre d'un essai clinique pour le traitement de l'event index;
    o Aucune récidive symptomatique objectivement documentée d'ETEV entre l'ETEV index et la randomisation ;
    o Durée anticipée du traitement anticoagulant d'au moins 12 mois au moment de la randomisation ;
    o Patients affiliés au régime de la Sécurité Sociale.
    E.4Principal exclusion criteria
    - WOCBP who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides)] to avoid pregnancy for the entire study
    - Women who are pregnant or breastfeeding
    - Women with a positive pregnancy test on enrollment or prior to investigational product administration
    - Isolated sub-segmental incidental or symptomatic PE without associated DVT
    - Isolated distal DVT of the legs
    - Isolated upper-extremity DVT or superior vena cava thrombosis
    - Isolated visceral thrombosis
    - Isolated catheter thrombosis
    - Objectively documented symptomatic recurrence of VTE after the index event under anticoagulant treatment
    - VTE during anticoagulant treatment given at therapeutic dosage
    - Subjects with indications for long-term treatment with a VKA, such as:
    Mechanical heart valve
    Antiphospholipid syndrome
    - Subjects with indication for long-term anticoagulation with a VKA or a DOAC at therapeutic dosage
    - Conditions increasing the risk of serious bleeding
    intracranial or intraocular bleeding within the 6 months ;
    major surgery within 2 weeks prior to randomization;
    - overt major bleeding at time of randomization.
    - Life expectancy < 3 months
    - Eastern Cooperative Oncology Group (ECOG) level 3 or 4
    - Bacterial endocarditis
    - Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg
    - Platelet count <50,000/mm3;
    - Creatinine clearance < 30 ml /min based on the Cockcroft Gault equation; (see Section 5.9.2);
    - Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range
    - Subjects requiring ASA >165 mg/day at randomization or thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor).
    - Subjects requiring dual anti-platelet therapy (such as ASA plus clopidogrel or ASA plus ticlopidine) at randomization. Subjects who transition from dual antiplatelet therapy to monotherapy prior to randomization will be eligible for the trial.
    - Concomitant use of strong inhibitors of both cytochrome P-450 3A4 and P Glycoprotein (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole) or strong inducers of both cytochrome P-450 3A4 and P Glycoprotein (e.g., rifampicin, carbamazepine, or phenytoin).
    - Prisoners or subjects who are involuntarily incarcerated
    - Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
    - Hypersensitivity to apixaban
    - Subjects participating in another pharmaco therapeutic program with an experimental therapy that is known to affect the coagulation system
    o Femmes en âge de procréer qui ne veulent pas ou ne peuvent pas utiliser une méthode acceptable de contraception (comme les contraceptifs oraux, autres contraceptifs hormonaux (produits vaginaux, patchs de la peau ou produits implantés ou injectables) ou des dispositifs mécaniques tels qu'un dispositif intra-utérin ou des méthodes de barrière (diaphragme, préservatifs, spermicides)] pour éviter la grossesse durant toute la durée de l'étude ;
    o Femmes enceintes ou allaitantes ;
    o Femmes ayant un test de grossesse positif à l'inclusion ou avant l'administration du traitement de l'étude ;
    o EP sous-segmentaires isolées de découverte fortuite ou symptomatiques sans TVP associée ;
    o TVP distale isolée des membres inférieurs ;
    o TVP isolée des membres supérieurs ou de la veine cave supérieure ;
    o Thrombose viscérale isolée ;
    o Thrombose isolée de cathéter ;
    o Récidive symptomatique objectivement documentée d'ETEV survenue dans les 6 mois après l'événement index sous traitement anticoagulant ;
    o ETEV survenu au cours du traitement anticoagulant administré à la dose thérapeutique ;
    o Sujets présentant une indication à un traitement au long cours avec AVK (antagoniste de la vitamine K) telles que:
    Valve cardiaque mécanique ; Syndrome des antiphospholipides ; Conditions augmentant le risque de saignement majeur
    (Saignement intracrânien ou intraoculaire dans les 6 mois / Chirurgie majeure dans les 2 semaines précédant la randomisation / Saignement majeur manifeste au moment de la randomisation)
    o Espérance de vie < 3 mois ;
    o Indice ECOG (Groupe coopératif d'oncologie de l'Est) niveau 3 ou 4 ;
    o Endocardite bactérienne ;
    o Hypertension incontrôlée: pression artérielle systolique > 180 mm Hg ou pression sanguine diastolique > 110 mm Hg ;
    o Nombre de plaquettes < 50 000 / mm3 ;
    o Détection de créatinine < 30 ml /min selon l'équation de Cockcroft Gault ;
    o Hépatite aiguë, hépatite chronique active, cirrhose hépatique ou une concentration d'alanine aminotransférase (ALAT) au moins 3 fois plus élevée que la valeur normale supérieure et / ou une concentration de bilirubine au moins 2 fois plus élevée à la valeur normale supérieure ;
    o Sujets nécessitant un traitement par aspirine à une dose > 165 mg /jour à la randomisation ou un traitement par thiénopyridine (clopidogrel, prasugrel ou ticagrelor) ;
    o Sujets nécessitant une bithérapie anti-plaquettaire (telle qu'aspirine plus clopidogrel ou aspirine plus ticlopidine) à la randomisation. Les sujets qui passent de la bithérapie antiplaquettaire à la monothérapie avant la randomisation seront éligibles pour l'essai.
    o Utilisation concomitante d'inhibiteurs forts du cytochrome P-450 3A4 et de la Glycoprotéine P (p. ex. Inhibiteurs de la protéase du VIH ou kétoconazole par voie systémique) ou des inducteurs forts du cytochrome P-450 3A4 et de la Glycoprotéine P (p. ex. rifampicine, carbamazépine ou phénytoïne).
    o Patient privé de liberté ou sous mesure de protection juridique ;
    o Patient interné pour le traitement d'une maladie psychiatrique ou physique (p. ex. maladie infectieuse).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the incidence of an adjudicated composite of recurrent symptomatic VTE (proximal and/or distal DVT and/or symptomatic PE and/or upper limb or CVC thrombosis) or incidental VTE (proximal DVT or PE), or death due to PE during the treatment period.


    The key secondary outcome is the incidence of adjudicated major and clinically relevant non-major bleeding during the treatment period.

    Other secondary endpoints:
    Adjudicated composite of :
    - Recurrent symptomatic VTE ;
    - VTE related-death ;
    - All-cause death: all deaths will be adjudicated by the ICAC and classified as either VTE-related, cancer death (including all deaths due to the underlying cancer), bleeding-related or others, including all deaths due to a clearly documented other cause, such as for example respiratory failure (e.g., terminal emphysema), infections/sepsis, etc. ;
    - Adjudicated major bleeding.
    Le critère d'évaluation principal :
    Incidence d'un critère composite de récidive d'ETEV symptomatique (TVP proximale et /ou distale et /ou EP symptomatique et / ou du membre supérieur ou thrombose de cathéter veineux central) ou d'ETEV de découverte fortuite (TVP proximale ou EP) ou décès dû à une EP pendant la période de traitement.

    Critères d'évaluation secondaires :
    Le critère d'évaluation secondaire majeur est l'incidence des saignements cliniquement pertinents (majeurs ou non majeurs) adjudiqués pendant la période de traitement.
    Les autres critères d'évaluation secondaires :
    - critère composite des événements adjudiqués suivants ;
    - récidive d'ETEV symptomatique ;
    - décès par ETEV ;
    - décès de toutes causes : tous les décès seront jugés par l'ICAC et classés comme soit étant liés à un ETEV, soit comme étant liés au cancer (y compris tous les décès dus au cancer sous-jacent), soit liés à un saignement, ou autres décès, y compris tous les décès dus à une autre cause clairement documentée, comme une insuffisance respiratoire (par exemple, un emphysème terminal), des infections / sepsis ;
    -Saignement majeur.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 months
    E.5.2Secondary end point(s)
    The key secondary outcome is the incidence of adjudicated major and clinically relevant non-major bleeding during the treatment period.

    Other secondary endpoints:
    Adjudicated composite of :
    - Recurrent symptomatic VTE ;
    - VTE related-death ;
    - All-cause death: all deaths will be adjudicated by the ICAC and classified as either VTE-related, cancer death (including all deaths due to the underlying cancer), bleeding-related or others, including all deaths due to a clearly documented other cause, such as for example respiratory failure (e.g., terminal emphysema), infections/sepsis, etc. ;
    - Adjudicated major bleeding.
    The key secondary outcome is the incidence of adjudicated major and clinically relevant non-major bleeding during the treatment period.

    Other secondary endpoints:
    Adjudicated composite of :
    - Recurrent symptomatic VTE ;
    - VTE related-death ;
    - All-cause death: all deaths will be adjudicated by the ICAC and classified as either VTE-related, cancer death (including all deaths due to the underlying cancer), bleeding-related or others, including all deaths due to a clearly documented other cause, such as for example respiratory failure (e.g., terminal emphysema), infections/sepsis, etc. ;
    - Adjudicated major bleeding.
    E.5.2.1Timepoint(s) of evaluation of this end point
    13 months
    13 months
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned51
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA155
    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
    Belgium
    France
    Germany
    Italy
    Netherlands
    Poland
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 1722
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-04-03. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    - Patients who do not master the French language
    - patients whose physical and mental abilities are altered by the evolution of their pathology
    - and patients with cognitive impaiment
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1680
    F.4.2.2In the whole clinical trial 1722
    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)
    Anticoagulant treatment, at the investigator's discretion
    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 Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-07
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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