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    Summary
    EudraCT Number:2017-003342-25
    Sponsor's Protocol Code Number:P170604J
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-10-02
    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 ConcernedNetherlands - Competent Authority
    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
    Langdurige behandeling van kankergerelateerde veneuze trombo-embolie verminderde vs. volledige dosis apixaban: API-CAT STUDIE naar APIxaban cankergerelateerde trombose
    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
    Langdurige behandeling van kankergerelateerde veneuze trombo-embolie verminderde vs. volledige dosis apixaban: API-CAT STUDIE naar APIxaban cankergerelateerde trombose
    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
    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, afterat 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.
    Elke kanker die histologisch is gediagnosticeerd (andere dan basaalcel- of plaveiselcelcarcinoom van de huid, primaire hersentumor of intra-cerebrale metastase) met objectief gedocumenteerde indexgebeurtenis van symptomatische of incidentele proximale DVT of symptomatische of incidentele PE, na ten minste 6 maanden antistollingstherapie voor de behandeling van de indexgebeurtenis, zonder objectief gedocumenteerde symptomatische herhaling van VTE tussen de indexgebeurtenis en randomisatie.
    E.1.1.1Medical condition in easily understood language
    Venous thrombosis or pulmonary embolism, with cancer
    Veneuze trombose of longembolie, met kanker
    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).
    Te bepalen of een lage dosering apixaban (2,5 mg b.i.d.) niet inferieur is aan een schema met een volledige dosering apixaban (5 mg b.i.d.) voor de preventie van recidiverende VTE bij patiënten met kanker die ten minste 6 maanden zijn behandeld met anticoagulantia voor de behandeling van een gedocumenteerd indexvoorval van (symptomatische of incidentele) proximale diepveneuze trombose (DVT) of (symptomatische of incidentele) longembolie (PE).
    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.
    De belangrijkste secundaire doelstelling is bepalen of een lage dosering apixaban (2,5 mg b.i.d.) veiliger is dan een schema met een volledige dosering apixaban (5 mg b.i.d.) bij patiënten met actieve kanker die ten minste 6 maanden zijn behandeld met anticoagulantia voor de behandeling van een gedocumenteerd indexvoorval van (symptomatische of incidentele) proximale DVT of (symptomatische of incidentele) PE.
    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.

    - Patient affiliated to social security for French centers.
    - Schriftelijk ondertekend formulier voor geïnformeerde toestemming

    - Histologisch gediagnosticeerde kanker

    - Actieve kanker gedefinieerd als de aanwezigheid van meetbare ziekte of lopende (of geplande) chemotherapie, radiotherapie, hormoontherapie, gerichte therapie, immuuntherapie op het moment van inclusie.

    - Objectief gedocumenteerd indexvoorval van:
    symptomatische of incidentele DVT in de onderste extremiteiten, vena iliaca, vena cava inferior of symptomatische of incidentele PE in een segmentale of grotere longarterie
    (1) Proximale DVT wordt gedefinieerd als DVT met betrokkenheid van ten minste de vena poplitea of een meer proximale ader, aangetoond door middel van beeldvorming met compressie-echografie (CUS) inclusief grijstinten of kleurgecodeerde Doppler of ascenderende venografie met contrastmiddel of computertomografie met versterkt contrast of beeldvorming met magnetische resonantie (MRI).
    (2) PE moet door middel van beeldvorming als volgt worden aangetoond:
    - een intraluminale stoornis bij het vullen van segmentale of meer proximale vertakkingen op basis van computertomografie met versterkt contrast of op basis van een CT-longangriografie; of
    - een intraluminale stoornis bij het vullen of een plotselinge afsluiting van vaten met een diameter van meer dan 2,5 mm op het longangiogram; of
    - een perfusiestoornis van ten minste 75 % van een segment met een plaatselijk normale ventilatieresultaat (hoge waarschijnlijkheid) bij de ventilatie-/perfusie-longscan (VPLS)
    (3) Incidentele VTE wordt gedefinieerd als proximale DVT of PE die door middel van beeldvorming per toeval is gedetecteerd tijdens beeldvormend onderzoek in het kade van standaard zorg bij de patiënt voor de beheersing van zijn of haar maligniteit of om andere redenen dan een vermoedelijke VTE (bijv. kankerdiagnose of -stadiëring).

    - Ten minste 6 maanden antistollingstherapie in een therapeutische dosering (ongeacht het geneesmiddel of de dosering), of voltooide toegewezen klinische studiebehandeling, voor de behandeling van de indexvoorval; en patiënt krijgt nog steeds een antistollingsbehandeling na optreden van het VTE-indexvoorval.

    - Geen objectief gedocumenteerde, symptomatische, recidiverende VTE tussen het indexvoorval en randomisatie.

    - Verwachte duur van de antistollingsbehandeling van ten minste 12 maanden op het moment van randomisatie.

    - Patiënt is aangesloten bij een ziektekostenverzekering voor Franse centra.
    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)
    - Vrouwen in de vruchtbare leeftijd die niet bereid of in staat zijn een algemeen aanvaarde anticonceptiemethode te gebruiken [zoals orale anticonceptiemiddelen, andere hormonale anticonceptiemiddelen (vaginale middelen, hormoonpleisters of geïmplanteerde of injecteerbare middelen), mechanische producten zoals een spiraaltje of barrièremethodes (condooms)] om gedurende de hele studie zwangerschap te voorkomen.

    - Patiënten die zwanger zijn of borstvoeding geven

    - Vrouwen die positief testen op zwangerschap op het moment van inclusie of voor toediening van het onderzoeksmiddel

    - Geïsoleerde subsegmentale (incidentele of symptomatische) PE zonder bijbehorende DVT

    - Geïsoleerde distale DVT in de benen

    - Geïsoleerde DVT in de bovenste extremiteiten of trombose van de vena cava superior

    - Geïsoleerde viscerale trombose

    - Geïsoleerde kathetertrombose

    - Objectief gedocumenteerde, symptomatische, recidiverende VTE na het indexvoorval tijdens de antistollingsbehandeling.

    - VTE tijdens een antistollingbehandeling in een therapeutische dosering

    - Patiënten met indicaties voor langdurige behandeling met een VKA, zoals:
    - Mechanische hartklep
    - Antifosfolipidesyndroom

    - Patiënten met een indicatie voor langdurige antistollingsbehandeling met een VKA of een DOAC in een therapeutische dosering

    - Aandoeningen met een verhoogd risico op ernstige bloedingen
    - intracraniële of intraoculaire bloeding in de 6 voorafgaande maanden
    - zware chirurgische ingreep in de 2 weken voorafgaand aan randomisering
    - open ernstige bloeding op het moment van randomisering

    - Een levensverwachting van minder dan 3 maanden

    - ECOG-prestatiescore (Eastern Cooperative Oncology Group) van 3 of 4

    - Bacteriële endocarditis

    - Patiënten met ongecontroleerde hypertensie: systolische bloeddruk van >180 mm Hg of diastolische bloeddruk van >110 mm Hg

    - Trombocytentelling van < 75.000/mm3

    - Hemoglobine van < 8 g/dl

    - Creatinineklaring van < 30 ml/min berekend volgens Cockroft-Gault (zie rubriek 5.7.4)

    - Acute hepatitis, chronische actieve hepatitis, levercirrose; of een alanineaminotransferasegehalte van 3 keer boven de bovengrens van het normale bereik (ULN) en/of een bilirubinegehalte van 2 keer boven ULN

    - Patiënten die op het moment van randomisering meer dan 165 mg/dag acetylsalicylzuur nodig hebben of behandeld worden met thiënopyridinen (clopidogrel, prasugrel of ticagrelor)

    - Patiënten die op het moment van randomisering twee vormen van antistollingsbehandeling krijgen (zoals acetylsalicylzuur met clopidogrel of acetylsalicylzuur met ticlopidine). Patiënten die voor randomisatie van tweeledige antistollingsbehandeling overstappen monotherapie komen in aanmerking voor de studie

    - Gelijktijdig gebruik van sterke remmers van cytochroom P450 3A4 en P-glycoproteïne (bijv. proteaseremmers voor het humaan immunodeficiëntievirus of systemische ketoconazol) of sterke inductoren van cytochroom P450 3A4 en P-glycoproteïne (bijv. rifampicine, carbamazepine of fenytoïne)

    - Gedetineerden of personen die tegen hun wil gevangen zitten

    - Patiënten die verplicht ter beschikking zijn gesteld voor behandeling van een psychiatrische of lichamelijke (bijv. een besmettelijke ziekte) aandoening

    - Overgevoeligheid voor apixaban

    - Patiënten die deelnemen aan een ander farmacotherapeutisch programma met een experimentele behandeling waarvan bekend is dat dit het bloedstollingssysteem beïnvloedt

    - Jonger dan 18 jaar

    - Patiënten onder wettelijke bescherming (voogdij)
    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.
    Het primaire eindpunt op gebied van werkzaamheid is een bepaalde samenstelling van recidiverende symptomatische VTE (proximale en/of distale DVT en/of symptomatische PE en/of trombose in de bovenste extremiteiten en/of CVC) of incidentele VTE (proximale DVT of PE), of overlijden als gevolg van PE tijdens de behandelingsperiode.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 maanden
    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.
    Het belangrijkste secundaire resultaat is de incidentie van bepaalde ernstige en klinisch relevante, niet-ernstige bloedingen tijdens de behandelingsperiode.

    Overige secundaire eindpunten:
    Bepaalde samenstelling van:
    - recidiverende symptomatische VTE;
    - VTE-gerelateerd overlijden;
    - overlijden door alle oorzaken;alle sterfgevallen worden ingedeeld in VTE-gerelateerd overlijden als gevolg van kanker (inclusief alle sterfgevallen als gevolg van de onderliggende kanker), bloedingsgerelateerd of overige, inclusief alle sterfgevallen als gevolg van een duidelijk gedocumenteerde andere oorzaak, zoals bijvoorbeeld extreme respiratoire insufficiëntie (bijv. terminaal emfyseem), infecties/sepsis enz. ;
    - Toegewezen ernstige bloedingen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    13 months
    13 maanden
    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 concerned7
    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
    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
    Laatste Bezoek Laatste Patiënt
    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 2019-10-02. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state77
    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
    Anticoagulantia, naar keuze van de onderzoeker
    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 Decision2019-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-03
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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