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    Summary
    EudraCT Number:2019-000570-33
    Sponsor's Protocol Code Number:FAAI2.10.2018
    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:2021-06-17
    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 number2019-000570-33
    A.3Full title of the trial
    The Jason study: Sulodexide (VESSEL®) for the prevention of recurrent venous thromboembolism in elderly patients after a first episode of venous thrombembolism (VTE)
    Studio Giasone
    Prevenzione secondaria con Sulodexide (VESSEL®) nei pazienti anziani dopo un primo episodio di tromboembolismo venoso (TEV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sulodexide (VESSEL®) for the prevention of a recurrent episode of deep vein thrombosis and/or pulmonary embolism in elderly patients
    Utilizzo del Sulodexide (VESSEL®) per la prevenzione di un nuovo episodio in pazienti anziani che hanno avuto un primo episodio di trombosi venosa profonda e/o embolia polmonare
    A.3.2Name or abbreviated title of the trial where available
    The Jason Study
    Studio Giasone
    A.4.1Sponsor's protocol code numberFAAI2.10.2018
    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 SponsorFONDAZIONE ARIANNA ANTICOAGULAZIONE
    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 supportALFASIGMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Arianna Anticoagulazione
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street Addressvia Paolo Fabbri 1/3, 1° piano, interno 2
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number051341471
    B.5.5Fax number051343604
    B.5.6E-mailsegreteria@fondazionearianna.org
    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 VESSEL - 250 ULS CAPSULE MOLLI 50 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderALFASIGMA
    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 nameVessel
    D.3.2Product code [Sulodexide]
    D.3.4Pharmaceutical form Capsule, soft
    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 INNSULODEXIDE
    D.3.9.1CAS number 57821-28-1
    D.3.9.2Current sponsor codeSulodexide
    D.3.9.4EV Substance CodePRD5392921
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule, soft
    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
    Prevention of recurrence after a first episode of VTE
    Prevenzione della recidiva dopo un primo episodio di tromboembolismo venoso
    E.1.1.1Medical condition in easily understood language
    Prevention of recurrent episode of deep vein thrombosis with or without pulmonary embolism in elderly patients
    Prevenzione di un nuovo episodio di trombosi venosa profonda con o senza embolia polmonare in pazienti anziani
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10043640
    E.1.2Term Thrombosis venous
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10034191
    E.1.2Term PE
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) Verify the efficacy of the treatment with two different doses of Sulodexide (Vessel®) (treatment A and treatment B) compared to the indistinguishable placebo (treatment C), in reducing the incidence of VTE relapses in elderly patients (age = 75 years) who have suffered from a recent episode of DVT (proximal lower extremity) and / or PE, by 35% compared to placebo.
    2) Verify the safety of the aforementioned therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not > 3%)
    Obiettivi
    1) Verificare l’efficacia del trattamento con due diverse dosi di Sulodexide (VESSEL®) (Trattamento A e Trattamento B) rispetto alla somministrazione di placebo indistinguibile (Trattamento C), nel ridurre l’incidenza di recidive di TEV del 35% rispetto al placebo in pazienti anziani (età = 75 anni), che hanno sofferto di un recente episodio di TVP (prossimale degli arti inferiori) e/o EP
    2) Verificare la sicurezza della suddetta terapia, dimostrando la non-inferiorità rispetto al placebo con un’incidenza di emorragie maggiori intorno allo 1% (limite superiore di confidenza non > 3%)
    E.2.2Secondary objectives of the trial
    N.A:
    N.A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
    2) Patients aged =75 years at the time of enrolment
    3) Pazienti with at lesast one of the known risk factors of bleeding (APPENDIX 1):
    a. Hypertension
    b. Renal failure
    c. Thrombocytopenia
    d. Diabetes
    e. Antiplatelet therapy (ASA maximum 140 mg/die)
    f. Frequent falls (>2 /years)
    g. Nonsteroidal anti-inflammatory drug
    h. Liver failure
    i. Previous Stroke
    j. Anemia
    k. Poor anticoagulant control
    l. Alcohol abuse
    4) Patients of both sexes.
    5) Patients who at the time of enrolment have already undergone a period of anticoagulant therapy (AT, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days.
    6) Patients with no other AT indications.
    7) Patients capable and able to provide informed consent.
    CRITERI DI INCLUSIONE:
    1) Pazienti con primo evento di TVP prossimale di un arto inferiore e/o EP, idiopatico o associato a fattori di rischio deboli o rimossi;
    2) Pazienti con età = 75 anni al momento dell’arruolamento;
    3) Pazienti che presentino almeno uno dei seguenti fattori di rischio noti per emorragia (APPENDICE 1):
    a) Ipertensione
    b) Insufficienza renale
    c) Piastrinopenia
    d) Diabete
    e) Terapia con ASA (massimo 140 mg/die) in corso
    f) Cadute frequenti (>2 all’anno)
    g) Uso di farmaci antinfiammatori non-steroidei
    h) Insufficienza epatica
    i) Pregresso ictus cerebrale
    j) Anemia
    k) Insufficiente controllo della terapia anticoagulante
    l) Abuso alcolico
    4) Pazienti di entrambi i sessi;
    5) Pazienti, che al momento dell’arruolamento, hanno già fatto un periodo di terapia anticoagulante (TA, con qualsiasi farmaco) di almeno 3 mesi e che la terapia non sia stata sospesa da più di 30 giorni;
    6) Pazienti che non hanno altre indicazioni per TA;
    7) Pazienti capaci e abili a fornire consenso informato.
    E.4Principal exclusion criteria
    1) Patients aged <75 years at the time of the recruitment visit.
    2) "Provoked" index event, which occurred:
    • Within 3 months of surgery or major trauma (general anesthesia> 30 min)
    • Relapse > 4 days,
    • Cast / immobilization within 3 months.
    3) Index event represented by severe PE, with life threatening risk or which involved thrombolytic therapy.
    4) Index event represented by isolated distal DVT or superficial venous thrombosis.
    5) Thrombotic event that involved sites other than the deep proximal veins of the lower limbs.
    6) Anticoagulant therapy in progress for less than 3 months at the time of enrolment.
    7) Discontinuation of anticoagulant therapy for over three months
    8) Recurrent episodes of DVT ± PE.
    9) Presence of severe post-thrombotic syndrome (Villalta score >15 or presence ofvenous ulcer).
    10) Presence of other clinical conditions requiring anticoagulant therapy.
    11) Active cancer.
    12) Presence of Inferior vena cava (IVC) filter.
    13) Known bleeding diatheses.
    14) Patients in therapy with antiplatelet medicinal products other than ASA. The ASA is allowed up to 140 mg / day.
    15) All clinical conditions requiring long-term treatment with low molecular weight heparin (LMWH).
    16) Presence of Antiphospholipid Antibody Syndrome (according to Sydney criteria)
    17) Known carriers of one or more of the following thrombophilic alterations: deficiency of physiological anticoagulants (antithrombin, protein C, protein S).
    18) Presence of chronic diseases in acute or active phase (e.g.: inflammatory bowel disease)
    19) Cardiorespiratory failure (New York Heart Association class 3 or 4).
    20) Patients incapacitated or refusing to sign the informed consent.
    21) Patients with life expectancy under 1 year.
    22) Patients residing in a disadvantaged geographical area.
    23) Patient already enrolled in other clinical trials.
    24) Patients with systolic pulmonary artery pressure > 40 mm hg (upper limit for elderly).
    25) Contraindication to Sulodexide (VESSEL®) and Placebo
    1) Pazienti con età < 75 anni al momento della visita di arruolamento;
    2) Evento indice “provocato”; cioè verificatosi:
    • entro 3 mesi da chirurgia o trauma maggiore (anestesia generale > 30 min)
    • allettamento > 4 giorni
    • gesso/immobilizzazione entro 3 mesi (con o senza fratture ed immobilizzazione)
    3) Evento indice rappresentato da EP severa (con rischio vitale o che ha comportato terapia trombolitica);
    4) Evento indice rappresentato da TVP distale isolata o trombosi venosa superficiale;
    5) Evento trombotico che ha coinvolto sedi diverse dalle vene profonde prossimali degli arti inferiori;
    6) Terapia anticoagulante in corso da meno di 3 mesi al momento dell’arruolamento;
    7) Terapia anticoagulante sospesa da più di 30 giorni al momento dell’arruolamento;
    8) Episodi recidivanti di TVP ± EP (non considerare come criteri di esclusione pregresse trombosi venose superficiali o distali isolate);
    9) Presenza di sindrome post-trombotica severa con score di Villalta > 15 e/o ulcera venosa degli arti inferiori;
    10) Presenza di altre condizioni cliniche che richiedono terapia anticoagulante;
    11) Neoplasia solida o ematica in fase attiva o per cui sia necessaria chemio/radioterapia;
    12) Presenza di filtro cavale;
    13) Diatesi emorragiche note;
    14) Pazienti in terapia con farmaci antiaggreganti piastrinici diversi da ASA. L’ASA è consentita fino a 140 mg/die;
    15) Tutte le condizioni cliniche che richiedono un trattamento prolungato con eparina a basso peso molecolare (LMWH);
    16) Sindrome da anticorpi antifosfolipidi (dimostrata secondo i criteri di Sydney);
    17) Portatori noti di una o più delle seguenti alterazioni trombofiliche: deficit degli anticoagulanti fisiologici (Antitrombina, Proteina C, Proteina S);
    18) Presenza di malattie croniche in fase acuta o attiva (es: malattia infiammatoria intestinale);
    19) Insufficienza cardio-respiratoria (Classe NYHA 3 o 4);
    20) Pazienti impossibilitati o che rifiutano di firmare il consenso informato;
    21) Pazienti con aspettativa di vita inferiore a 1 anno;
    22) Pazienti residenti in sede geografica disagiata;
    23) Paziente già arruolato ad altri studi clinici;
    24) Pazienti con pressione polmonare sistolica > 40 mm Hg (limite superiore previsto per anziani);
    25) Controindicazione al trattamento sperimentale [Sulodexide (VESSEL®) e Placebo].
    E.5 End points
    E.5.1Primary end point(s)
    • Primary efficacy endpoint:
    - cumulative result of: new episodes of venous thromboembolism (proximal DVT and / or PE), overall mortality due to VTE
    • Primary safety endpoint:
    - incidence of major bleeding (MB), International Society on Thrombosis and Haemostasis [ISTH] criterion)
    • Endpoint primario di efficacia:
    Risultato cumulativo di: nuovo episodio di tromboembolia venosa (TVP prossimale e/o EP), mortalità totale per TEV
    • Endpoint primario di sicurezza:
    Incidenza di emorragie maggiori [EM, criterio ISTH]
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the entire duration of follow-up
    Per tutta la durata dello studio
    E.5.2Secondary end point(s)
    - Secondary efficacy endpoint:Cardiovascular events that involved hospitalization;
    - Death from cardiovascular events (myocardial infarction, ischemic stroke).
    • Secondary safety endpoint:
    - Cumulative incidence of MB and non-major but clinically relevant haemorrhages [NMCRB]
    • Endpoint secondario di efficacia:
    Eventi cardiovascolari che hanno comportato un ricovero ospedaliero;
    Morte per eventi cardiovascolari (infarto miocardico, ictus ischemico)
    • Endpoint secondario di sicurezza:
    Incidenza cumulativa di EM e di emorragie non-maggiori ma clinicamente rilevanti [ENMCR]
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the entire duration of follow-up
    Per tutta la durata dello studio
    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 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 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 trial3
    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 concerned53
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 Patient
    ultima visita dell'ultimo soggetto indicare LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1455
    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 state1455
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1455
    F.4.2.2In the whole clinical trial 1455
    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)
    As a routine clinical practice
    Come normale pratica clinica
    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 Decision2019-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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