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    Summary
    EudraCT Number:2013-004575-13
    Sponsor's Protocol Code Number:TRAPS-1.5
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-004575-13
    A.3Full title of the trial
    A prospective, randomized clinical trial comparing Rivaroxaban vs warfarin in high risk patients with antiphospholipid syndrome (TRAPS).
    Studio clinico prospettico, randomizzato di confronto tra Rivaroxaban vs Warfarin in pazienti ad alto rischio con sindrome da anticorpi antifosfolipidi (TRAPS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, randomized clinical trial comparing Rivaroxaban vs warfarin in high risk patients with antiphospholipid syndrome (TRAPS).
    Studio clinico prospettico, randomizzato di confronto tra Rivaroxaban vs Warfarin in pazienti ad alto rischio con sindrome da anticorpi antifosfolipidi (TRAPS)
    A.3.2Name or abbreviated title of the trial where available
    TRAPS
    TRAPS
    A.4.1Sponsor's protocol code numberTRAPS-1.5
    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 SponsorDipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer Italia spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Scienze Cardiologiche, Toraciche e Vascolari Università di Padova
    B.5.2Functional name of contact pointProf. Vittorio Pengo
    B.5.3 Address:
    B.5.3.1Street Addressvia Giustiniani 2
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35138
    B.5.3.4CountryItaly
    B.5.4Telephone number+390498215658
    B.5.5Fax number+390498215658
    B.5.6E-mailvittorio.pengo@unipd.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name XARELTO
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG, 13342, Berlin Germania
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXARELTO
    D.3.2Product code BAY 59-7939
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Yes
    D.2.1.1.1Trade name COUMADIN
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb S.r.l., Via Virgilio Maroso, 50 - Roma
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCOUMADIN
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    THROMBOEMBOLISM PREVENTION
    PREVENZIONE TROMBOEMBOLIA
    E.1.1.1Medical condition in easily understood language
    THROMBOEMBOLISM PREVENTION
    PREVENZIONE TROMBOEMBOLIA
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    demonstrate the non-inferiority of Rivaroxaban 20 mg (or 15mgqd in case of moderate renal insufficiency) versus warfarin (INR 2.0-3.0) with respect to the occurrence of the cumulative end point of incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleedings, and death in triple aPL-positive APS patients.
    dimostrare la non inferiorità di rivaroxaban 20 mg (o 15mg in caso di insufficienza renale moderata) rispetto a warfarin (INR 2,0-3,0) nel prevenire l’end-point primario cumulativo di tromboembolismo ( arterioso o venoso ) confermato da studi appropriati di imaging, di sanguinamenti maggiori e di morte in pazienti con APS e tripla positività ai test di laboratorio.
    E.2.2Secondary objectives of the trial
    compare any single component of the cumulative end-point:
    • Any thromboembolic event, as deep vein thrombosis, pulmonary embolism, intracerebral thrombosis, retinal thrombosis, peripheral- or mesenteric-artery thrombosis, small vessel thrombosis, acute myocardial infarction, stroke/TIA
    • Major bleeding, defined as:
    o fatal (causing death), and/or
    o clinically overt bleeding associated with a fall in hemoglobin level of ≥20 g/L in 24 hours, and/or requiring non-planned transfusion of ≥2 units of packed red blood cells or whole blood
    o in a critical area or organ, e.g. intracranial bleeding (documented by imaging), retroperitoneal bleeding, intraspinal bleeding, intraocular bleeding causing blindness, pericardial bleeding, joint hemorrhage, or need for surgery or angiographic intervention to stop hemorrhage
    • All-cause mortality
    As well as:
    • Minor bleeding
    ogni singolo componente dell’ end-point cumulativo :
    • Ogni evento tromboembolico, come trombosi venosa profonda, embolia polmonare , trombosi intracerebrale, trombosi retinica , trombosi periferica, trombosi dei piccoli vasi, infarto miocardico acuto, ictus / TIA.
    • sanguinamento maggiore , definito come :
    - fatale, e / o -sanguinamento clinicamente evidente associato ad un abbassamento del livello di emoglobina ≥ 20 g / L in 24 ore, e / o che richiede trasfusioni non pianificata di ≥ 2 unità di globuli rossi concentrati o sangue intero.
    -sanguinamento in una zona critica, ad esempio emorragia intracranica ( documentato da immagini ) , sanguinamento retroperitoneale, emorragia intraspinale, sanguinamento intraoculare che causa cecità , sanguinamento pericardico , emorragie articolari, o la necessità di un intervento chirurgico o un intervento angiografico per arrestare l’ emorragia
    • tutte le cause di morte
    Ma anche: • Casi di sanguinamento minore
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent form
    2. Male or female of age 18-60 years
    3. Triple aPL-positivity in the last blood sampling defined as:
    3.1. aCL IgG/M (≥40 GPL or MPL, medium-to-high titer, and/or greater than the 99th percentile) and
    3.2. aB2GPI IgG/M (≥40 U, medium-to-high titer, and/or greater than the 99th percentile) and
    3.3. LA test positive based on the International Society of Thrombosis & Hemostasis Recommendations)
    3.4. Positivity of aCL and abeta2GPI must be of the same isotype.
    4. History of thrombosis (objectively proven arterial, venous, and/or biopsy proven microthrombosis) and/or pregnancy morbidity according to Miyakis
    1 . Modulo di consenso informato firmato e datato
    2 . Maschio o femmina, di età 18-60 anni
    3 . Tripla aPL - positività nell'ultimo prelievo di sangue, definita come:
    3.1 . aCL IgG/M (≥ 40 GPL o MPL, medio-alto titolo, e / o maggiore del 99 ° percentile ) e
    3.2 . aB2GPI IgG / M ( ≥ 40 U , medio- alto titolo , e / o maggiore del 99 ° percentile ) e
    3.3 . LA positivo secondo le raccomandazioni della Società Internazionale di Trombosi e Emostasi.
    3.4 . La positività di aCL e abeta2GPI deve essere dello stesso isotipo.
    4 . Storia di trombosi (arteriosa o venosa provata con biopsia nei casi di trombosi del microcircolo) e/o patologia gravidica secondo Miyakis
    E.4Principal exclusion criteria
    1. Severe hypersensitivity reaction to rivaroxaban
    2. Calculated CLCR <30 mL/min at the screening visit
    3. Current pregnancy or breast feeding.
    4. Concomitant treatment with other anticoagulants.
    5. Patients taking interfering medications: pharmacologic interactions may occur with strong inhibitors of p-glycoprotein and of cyp3a4 and hiv protease inhibitors
    6. Hemorrhage Risk-Related Criteria
    7. Known liver cirrhosis or ALT above three times
    UNV
    1. Grave reazione di ipersensibilità a rivaroxaban
    2 . CLCR < 30 ml/min alla visita di screening
    3 . Gravidanza in corso o l'allattamento al seno
    4. trattamento concomitante con altri anticoagulanti
    5. assumono farmaci che interferiscono con rivaroxaban: interazioni farmacologiche possono verificarsi con forti inibitori della p -glicoproteina e del CYP3A4 e inibitori della proteasi nei pazienti con HIV
    6. Criteri relativi al rischio di emorragia
    7.Cirrosi epatica nota o ALT superiore tre volte UNV
    E.5 End points
    E.5.1Primary end point(s)
    cumulative outcome measures will be incident acute thrombosis (arterial or venous) confirmed by appropriate imaging studies, major bleeding, or death
    di tipo cumulativo ed è costituito da trombosi (arteriose o venose) confermate da studi di imaging, sanguinamenti maggiore , e mortalità
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 mo, 3 mo, 6 mo and each 6 mo
    1 mese, 3 mesi, 6 mesi e poi ogni 6 mesi
    E.5.2Secondary end point(s)
    Separate evaluation of arterial and venous thrombosis, major bleeding and mortality.
    Compliance to treatment evaluating pill counts each follow up visit.
    Secondary Safety Outcome
    Major bleeding and minor bleeding, defined as any bleeding event not matching the criteria for major bleeding.
    valutazione separata di trombosi arteriosa e venosa, emorragie maggiori e mortalità .
    • Compliance al trattamento valutata con la conta delle compresse ad ogni visita di follow-up .
    Outcome secondario di sicurezza:
    Sanguinamento maggiore e sanguinamenti minori, definite come qualsiasi episodio di sanguinamento non corrispondenti ai criteri di sanguinamento maggiore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 mo, 3 mo, 6 mo and each 6 mo
    1 mese, 3 mesi, 6 mesi e poi ogni 6 mesi
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    88 EVENTS REACHED OR 4 YEARS FOLLOW-UP
    RAGGIUNGIMENTO DI 88 EVENTI O 4 ANNI DI FOLLOW-UP
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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.1.3Elderly (>=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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 535
    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)
    NONE
    NO
    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 Decision2014-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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