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    Summary
    EudraCT Number:2017-003342-25
    Sponsor's Protocol Code Number:P170604J
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-13
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-003342-25
    A.3Full title of the trial
    Long-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis
    Langzeitbehandlung von krebsassoziierter venöser Thromboembolie: Reduzierte versus volle Dosierung von Apixaban API-CAT STUDIE für APIxaban bei krebsassoziierter Thrombose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term treatment of cancer associated venous thromboembolism: reduced vs full dose of apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis
    Langzeitbehandlung von krebsassoziierter venöser Thromboembolie: Reduzierte versus volle Dosierung von Apixaban API-CAT STUDIE für APIxaban bei krebsassoziierter Thrombose
    A.3.2Name or abbreviated title of the trial where available
    API-CAT
    API-CAT
    A.4.1Sponsor's protocol code numberP170604J
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03692065
    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 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.2.1.1.1Trade 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
    Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis) with objectively documented index event of symptomatic or incidental proximal DVT or symptomatic or incidental PE, after at least 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.
    Jeder histologisch diagnostizierte Krebs (außer Basalzell- oder Plattenepithelkarzinom der Haut, primärer Gehirntumor oder intrazerebrale Metastasierung) mit objektiv dokumentiertem Indexereignis einer symptomatischen oder zufällig diagnostizierten proximalen TVT nach mindestens 6 Monaten Antikoagulationsbehandlung des Indexereignisses und keinem objektiv dokumentierten symptomatischen Rezidiv der VTE zwischen Indexereignis und Randomisierung.
    E.1.1.1Medical condition in easily understood language
    Venous thrombosis or pulmonary embolism, with cancer
    Venenthrombose oder Lungenembolie mit Krebs
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 VTE in patients with cancer who have completed at least 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).
    Das primäre Ziel hinsichtlich der Wirksamkeit ist es, festzustellen, ob ein niedrig dosiertes Schema mit Apixaban (zwei mal täglich 2,5 mg) einem Schema mit voller Dosierung von Apixaban (zwei mal täglich 5 mg ) zur Prävention von rezidivierenden VTE bei Krebspatienten, die mindestens 6 Monate eine Antikoagulationsterapie zur Behandlung eines dokumentierten Indexereignisses einer proximalen tiefen Venenthrombose (TVT) (symptomatisch oder zufällig diagnostiziert) oder Lungenembolie (LE) (symptomatisch oder zufällig diagnostiziert) abgeschlossen haben, nicht unterlegen ist.
    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 cancer who have completed at least 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.
    Das wesentliche sekundäre Ziel ist es, festzustellen, ob ein niedrig dosiertes Schema mit Apixaban (zwei mal täglich 2,5 mg) bei Patienten mit aktivem Krebs, die mindestens 6 Monate eine Antikoagulationstherapie zur Behandlung eines dokumentierten Indexereignisses einer proximalen tiefen Venenthrombose (TVT) (symptomatisch oder zufällig diagnostiziert) oder Lungenembolie (LE) (symptomatisch oder zufällig diagnostiziert) abgeschlossen haben, sicherer ist als ein Schema mit voller Dosierung von Apixaban (zwei mal täglich 5 mg).

    Weitere sekundäre Ziele
    Vergleich der Therapieeffekte der reduzierten Dosierung von Apixaban mit denen der vollen Dosierung bei:
    • rezidivierender symptomatischer VTE;
    • auf VTE zurückzuführenden Tod
    • Tod jeglicher Ursache
    • Schwere Blutungen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Written Informed Consent

    - Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis

    - Active cancer defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy, hormonotherapy, targeted therapy, immunotherapy 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).

    - At least 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 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.

    - Unterschriebene schriftliche Einwilligungserklärung

    - Jeder histologisch diagnostizierte Krebs (außer Basalzell- oder Plattenepithelkarzinom der Haut, primärer Gehirntumor oder intrazerebrale Metastasierung)

    - Aktive Krebserkrankung, definiert als das Vorhandensein einer messbaren Erkrankung oder einer laufenden (oder geplanten) Chemotherapie, Strahlentherapie, Hormontherapie, zielgerichtete Therapie oder Immuntherapie bei der Aufnahme.

    - Objektiv dokumentiertes Indexereignis einer:
    symptomatischen oder zufällig diagnostizierten TVT der proximalen unteren Extremität, Beckenvene, Vena cava inferior oder symptomatischen oder zufällig diagnostizierten LE in einer segmentalen oder größeren Lungenarterie.
    (1) Proximale TVT ist definiert als TVT, die mindestens die Vena poplitea oder eine proximale Vene betrifft, nachgewiesen durch Bildgebung mit Kompressionsultraschall (CUS), einschließlich Graustufenscan oder farbcodiertem Doppler, aufsteigender Kontrastvenographie oder kontrastmittelverstärkter Computertomographie oder Magnetresonanztomographie.
    (2) LE ist durch Bildgebung wie folgt nachzuweisen:
    - intraluminaler Füllungsdefekt in segmentalen oder proximaleren Zweigen in der kontrastmittelverstärkten Computertomographie der Brust oder in der Computertomografie- Pulmonalisangiografie; oder
    - intraluminaler Füllungsdefekt oder plötzliche Abtrennung von Gefäßen mit einem Durchmesser von mehr als 2,5 mm im Pulmonalisangiogramm; oder
    - Perfusionsdefekt von mindestens 75% eines Segments mit einem lokal normalen Belüftungsergebnis (hohe Wahrscheinlichkeit) beim Ventilations-Perfusions-Lungenscan (VPLS)
    (3) Als zufällig diagnostizierte VTE gilt eine proximale TVT oder LE, die durch die Bildgebung zufällig erkannt wird, wenn ein Patient sich Bildgebungsuntersuchungen als Standardbehandlung zur Behandlung von Malignomen oder aus anderen Gründen unterzieht, nicht aber aufgrund eines Verdachts auf VTE (z.B. Krebsdiagnose oder Stadienbestimmung).

    - Antikoagulationsbehandlung in therapeutischer Dosierung (unabhängig von Medikament und Dosierung) über mindestens 6 Monate oder Abschluss einer zugewiesenen Behandlung in einer klinischen Studie zur Behandlung des Indexereignisses; und Patienten, die nach dem Auftreten der VTE oder nach dem Indexereignis einer VTE noch eine Antikoagulationsbehandlung erhalten.

    - Kein objektiv dokumentiertes symptomatisches Rezidiv der VTE zwischen Indexereignis und Randomisierung.

    - Teilnehmer müssen die Dauer der Antikoagulationsbehandlung von mindestens 12 Monaten ab Zeitpunkt der Randomisierung eingeplant haben.

    - Patienten die der Krankenversicherung für französische Prüfzentren angehören.
    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 (condoms)] 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 < 12 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 <75,000/mm3;

    - Hemoglobin < 8g /dl

    - 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

    - Under 18 years old ;

    - Patients under legal protection (guardianship)
    - Frauen im gebärfähigen Alter, die nicht bereit oder nicht in der Lage sind, eine akzeptable Empfängnisverhütungmethode anzuwenden [orale Verhütungsmittel, andere hormonelle Verhütungsmittel (Vaginalprodukte, Hautpflaster, implantierte oder injizierbare Produkte) oder mechanische Produkte wie ein Intrauterinpessar oder Barrieremethoden (Kondome)], um eine Schwangerschaft während der gesamte Studien zu vermeiden.

    - Schwangere und stillende Frauen

    - Frauen mit einem positiven Schwangerschaftstest bei der Aufnahme oder vor der Verabreichung eines Prüfpräparats.

    - Isolierte subsegmentale (zufällig diagnostizierte oder symptomatisches) LE ohne zugehörige TVT

    - Isolierte distale TVT der Beine

    - Isolierte TVT der oberen Extremität oder Thrombose der Vena cava superior

    - Isolierte viszerale Thrombose

    - Isolierte Katheterthrombose

    - Objektiv dokumentiertes symptomatisches Rezidiv von VTE nach dem Indexereignis unter Antikoagulationsbehandlung

    - VTE während der Antikoagulationsbehandlung bei therapeutischer Dosierung

    - Probanden mit Indikationen zur Langzeitbehandlung mit einem VKA (Vitamin-K-Antagonisten), wie z.B.:
    Mechanischer Herzklappenersatz
    Antiphospholipid-Syndrom

    - Personen mit Indikation zur Langzeit-Antikoagulation mit VKA oder DOAC (direkte orale Antikoagulanzien) in therapeutischer Dosierung
    - Bedingungen, die das Risiko schwerer Blutungen erhöhen.
    intrakranielle oder intraokulare Blutungen innerhalb der 6 Monate
    Größere chirurgische Eingriffe innerhalb der 2 Wochen vor der Randomisierung
    offensichtliche starke Blutung zum Zeitpunkt der Randomisierung

    - Lebenserwartung < 12 Monate

    - Performance-Status 3 oder 4 der Eastern Cooperative Oncology Group (ECOG)

    - Bakterielle Endokarditis

    - Nicht eingestellte Hypertonie: systolischer Blutdruck >180 mm Hg oder diastolischer Blutdruck >110 mm Hg

    - Thrombozytenzahl < 75,000/mm3

    - Hämoglobin < 8g /dl

    - Kreatinin-Clearance < 30 ml /min basierend auf der Cockcroft Gault Gleichung ( siehe Abschnitt 5.7.4)

    - Akute Hepatitis, chronische aktive Hepatitis, Leberzirrhose; 3-fach oder mehrfach erhöhter Alaninaminotransferase-Spiegel und/oder zweifach oder mehr erhöhter Bilirubinspiegel oder als die Obergrenze des Normalbereichs

    - Probanden, die ASS >165 mg/Tag bei Randomisierung oder Thienopyridintherapie benötigen (Clopidogrel, Prasugrel oder Ticagrelor)

    - Probanden, die zum Zeitpunkt der Randomisierung eine duale Anti-Thrombozyten-Therapie benötigen (z.B. Acetylsalicylsäure plus Clopidogrel oder Acetylsalicylsäure plus Ticlopidin). Probanden, die vor der Randomisierung von der dualen Anti-Thrombozyten-Therapie auf die Monotherapie umgestellt werden, kommen für die Studie in Frage.

    - Gleichzeitige Einnahme starker Inhibitoren wie CYP3A4-Inhibitoren und P-Glykoprotein-Inhibitoren (z.B. HIV-Proteaseinhibitoren oder systemisch verabreichtes Ketoconazol) oder starker Induktoren wie CYP3A4-Induktoren und P-Glykoprotein-Induktoren (z.B. Rifampicin, Carbamazepin oder Phenytoin).

    - Häftlinge und zwangsweise internierte Personen

    - Personen, die zwangsweise zur Behandlung einer psychiatrischen oder physischen (z.B. Infektionskrankheit) Krankheit festgehalten werden.

    - Hypersensibilität gegen Apixaban

    - Personen, die an einem anderen pharmakotherapeutischen Programm mit einer experimentellen Behandlung teilnehmen, von der bekannt ist, dass sie das Gerinnungssystem beeinflusst.

    - Personen unter 18 Jahren

    - Patienten unter gesetzlicher Betreuung (Vormundschaft)
    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.
    Der primäre Endpunkt ist die Häufigkeit einer adjudizierten Kombination aus rezidivierender symptomatischer VTE (proximale und/oder distale TVT und/oder symptomatischer PE und/oder Thrombose der oberen Extremität oder durch ZVK) oder VTE als Zufallsbefund (proximale TVT oder LE) oder Tod durch LE während der Behandlungszeitraums.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 Monate
    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.
    Das wichtigste sekundäre Ergebnis ist die Inzidenz von adjudizierten schwerwiegenden und klinisch relevanten nicht schwerwiegenden Blutungsereignissen während der Behandlungsdauer.

    Weitere sekundäre Endpunkte:
    Adjudizierte Kombination von:
    - rezidivierender symptomatischer VTE;
    - auf VTE zurückzuführenden Tod;
    - Tod jeglicher Ursache:alle Todesfälle werden entweder als Tod durch VTE, krebsbedingte Todesfälle (einschließlich aller Todesfälle durch den zugrunde liegenden Krebs), blutungsbedingt oder durch andere Ursachen bedingt eingestuft, einschließlich aller Todesfälle aufgrund einer eindeutig dokumentierten anderen Ursache, wie z.B. Atemversagen (z.B. terminales Emphysem), Infektionen/Sepsis etc. ;
    - Adjudizierte schwerwiegende Blutung
    E.5.2.1Timepoint(s) of evaluation of this end point
    13 months
    13 Monate
    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 concerned4
    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
    Austria
    Belgium
    Canada
    France
    Greece
    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
    Last Visit Last Subject
    Letzte Visite des letzten Patienten
    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 months7
    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: 690
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1032
    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 state66
    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
    Behandlung mit Antikoagulanzien nach Ermessen des Prüfarztes
    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 Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-28
    P. End of Trial
    P.End of Trial StatusOngoing
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