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    Summary
    EudraCT Number:2016-003627-29
    Sponsor's Protocol Code Number:PREVENTIHSSTUDY(FARM12L9JE)
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-03-02
    Trial results View 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 number2016-003627-29
    A.3Full title of the trial
    PREvention of VENous Thromboembolism In Hemorrhagic Stroke patients
    PREvention of VENous Thromboembolism In Hemorrhagic Stroke patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PREvention of VENous Thromboembolism In Hemorrhagic Stroke patients
    Prevenzione del tromboembolismo venoso in pazienti con emorragia cerebrale primitiva
    A.3.2Name or abbreviated title of the trial where available
    PREVENTIHS STUDY
    PREVENTIHS STUDY
    A.4.1Sponsor's protocol code numberPREVENTIHSSTUDY(FARM12L9JE)
    A.5.4Other Identifiers
    Name:PREVENTIHS STUDY (FARM12L9JE)Number:PREVENTIHS STUDY (FARM12L9JE)
    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 SponsorOSPEDALE SANTA MARIA DELLA MISERICORDIA
    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 support
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità degli Studi di Perugia
    B.5.2Functional name of contact pointStroke Unit
    B.5.3 Address:
    B.5.3.1Street AddressOspedale S. Maria della Misericordia Perugia
    B.5.3.2Town/ cityPerugia
    B.5.3.3Post code06129
    B.5.3.4CountryItaly
    B.5.4Telephone number0755782765
    B.5.5Fax number0755782436
    B.5.6E-mailmaurizio.paciaroni@unipg.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 CLEXANE - 4000 UI AXA SOLUZIONE INIETTABILE 6 SIRINGHE PRERIEMPITE DA 0.4 ML
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS S.P.A.
    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 nameenoxaparina
    D.3.2Product code enoxaparina
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARINA SODICA
    D.3.9.1CAS number 9005-49-6
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameENOXAPARINA SODICA
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000
    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 Yes
    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
    hemorrhagic stroke
    emorragia cerebrale intraparenchimale spontanea
    E.1.1.1Medical condition in easily understood language
    hemorrhagic stroke
    emorragia cerebrale
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10047065
    E.1.2Term Vascular disorders
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    the use of standard treatment alone (compression stockings and /or intermittent pneumatic compression and /or early mobilization) will be compared with the use of standard treatment plus the administration of the low molecular weight heparin enoxaparin for the prevention of VTE in patients with acute hemorrhagic stroke.
    L’obiettivo di questo studio multicentrico sarà quello di comparare l’uso della terapia standard da sola (calze elastiche a compressione graduale e/o con compressione pneumatica intermittente e/o mobilizzazione precoce) versus terapia standard associato alla somministrazione di dosi profilattiche di eparina a basso peso molecolare per 10 giorni dopo un evento cerebrale emorragico nella prevenzione di tromboembolia venosa.
    E.2.2Secondary objectives of the trial
    the safety of enoxaparin in this clinical setting will also be assessed.
    la sicurezza dell’eparina a basso peso molecolare in questi pazienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consecutive bedridden patients (a score of 3 or 4 per item 6 of the NIHSS or the impossibility to maintain an upright position such as in the case of ataxia in patients with hemorrhagic cerebellar stroke) 18 years of age or older with primary intracerebral hemorrhage on CT scan or patients with intracranial hemorrhage during treatment with oral anticoagulants (after reversal), will be assessed for eligibility.
    Verranno inclusi pazienti con età uguale o superiore a 18 anni con emorragia cerebrale intraparenchimale spontanea diagnosticata con Tomografia Computerizzata (TC) che determini allettamento (item dell’arto inferiore della NIHSS uguale a 3 o 4 o in caso di emorragia cerebellare, impossibilità alla stazione eretta per atassia).
    E.4Principal exclusion criteria
    Exclusion criteria will include: intracranial hemorrhage due to vascular malformation, bleeding disorders (defined by a prothrombin time more than 30% longer than the control value or a platelet count of less than 100,000 per cubic millimetre), renal failure defined as a clearance of creatinine less than 30, severe hepatic failure, known neoplastic disease, pregnancy, necessity of therapeutic anticoagulant or antiplatelet agents for concomitant disease, participation in other ongoing clinical trials or patient refusal to consent.
    Verranno esclusi pazienti con emorragia cerebrale secondaria a malformazione vascolare mentre saranno inclusi pazienti con emorragia cerebrale durante terapia con anticoagulanti orali anche se trattati in fase acuta per neutralizzare l’attività dell’anticoagulante stesso.
    Criteri di esclusione:
    - Presenza di disordini emocoagulativi definiti come PTT maggiore di 30 o una conta piastrinica di meno di 100.000 per mm/cubo;
    - Insufficienza renale definitiva con livelli di clearance della creatinina <30;
    - Insufficienza epatica severa;
    - Nota patologia neoplastica;
    - Gravidanza;
    - Necessità di terapia con antitrombotici per patologie concomitanti (es. sindrome coronaria acuta);
    - Partecipazione ad altri trials clinici farmacologici;
    - Rifiuto da parte del paziente o di un familiare di dare il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be made up of either: 1) symptomatic venous thromboembolism objectively documented as proximal/distal DVT or pulmonary embolism or 2) asymptomatic proximal/distal DVT documented by ultrasound at the end of follow-up.
    L’end-point primario sarà costituito da tromboembolismo venoso sintomatico obiettivamente documentato (trombosi venosa profonda prossimale o distale o embolia polmonare) o trombosi venosa profonda prossimale o distale asintomatica documentata dall’esame ecografico previsto al termine del trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 days
    10 giorni
    E.5.2Secondary end point(s)
    Secondary end-points:
    1. The number of symptomatic and asymptomatic intracranial bleedings as described above in Methods;
    2. The number of extracranial bleedings will be divided into two groups: major and minor. Major bleedings will be defined as 1) presence in critical organ sites including the retroperitoneal and intraocular spaces, 2) a reduction of 2 or more gr/dL of hemoglobin or the need to carry out a transfusion of 2 or more units of concentrate red blood cells or 3) fatal bleeding. Medical intervention, including any interruption of study treatment, will be considered clinically relevant but not a major bleeding for all the events that do not satisfy the above described criteria. All other bleedings will be considered minor;
    3. The combined end-point of disability (modifed Rankin Scale ≥ 3) and mortality for any cause at 90 days;
    4. Mortality alone at 90 days.
    End-points secondari saranno:
    1. numero di sanguinamenti intracranici sintomatici o asintomatici valutati come già descritto nei metodi;
    2. numero di sanguinamenti extracranici. I sanguinamenti saranno considerati maggiori se si verificheranno in organi critici (es. retroperitoneali, intraoculari), se determineranno una riduzione di 2 gr/dL di emoglobina o richiederanno la trasfusione di 2 o più sacche di globuli rossi concentrati o se saranno fatali. Verranno invece considerati clinicamente rilevanti ma non maggiori tutti gli eventi che non risponderanno ai criteri precedentemente descritti, ma che richiederanno l’intervento medico, compresa l’interruzione anche temporanea del trattamento. Tutti gli altri sanguinamenti saranno considerati minori;
    3. end-point combinato disabilità (modifed Rankin Scale ≥ 3) e mortalità per ogni causa a 90 giorni;
    4. mortalità da sola a 90 giorni.
    Per ogni evento che fa parte degli endpoints (sia primari che secondari), il centro interessato dovrà inviare adeguata documentazione dello stesso per essere aggiudicato dal comitato di aggiudicazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 and 90 days
    10 e 90 giorni
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    valutazione outcome PROBE
    PROBE outcome evaluation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia standard non farmacologica
    not farmacological standard therapy
    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 concerned10
    E.8.5The trial involves multiple Member States No
    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 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
    LVLS
    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 months3
    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 months3
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 121
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 285
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-03-02. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    afasic patients
    pazienti con afasia
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state406
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 406
    F.4.2.2In the whole clinical trial 406
    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)
    ambulatory visits as clinical practice
    visite di controllo come nella comune 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 Decision2017-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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