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    Summary
    EudraCT Number:2013-001617-32
    Sponsor's Protocol Code Number:MINOR
    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:2013-06-07
    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 number2013-001617-32
    A.3Full title of the trial
    Thrombolysis in Minor Stroke
    Trombolisi negli ictus minori
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acute treatment for mild strokes by means of a drug able to dissolve the thrombus
    Trattamento acuto di ictus di grado lieve mediante farmaco capace di dissolvere il trombo
    A.3.2Name or abbreviated title of the trial where available
    MINOR Study
    Studio MINOR
    A.4.1Sponsor's protocol code numberMINOR
    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 SponsorAUSL di Piacenza
    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 supportMinistry of Health
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAUSL di Piacenza
    B.5.2Functional name of contact pointUOC Neurologia Osp. G. da Saliceto
    B.5.3 Address:
    B.5.3.1Street AddressVia Cantone del Cristo n. 40
    B.5.3.2Town/ cityPiacenza
    B.5.3.3Post code29121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390523303308
    B.5.5Fax number00390523303322
    B.5.6E-maildirezione.sanitaria@ausl.pc.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 Actilyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    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 nameACTILYSE
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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) Yes
    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 Yes
    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 CARDIOASPIRIN
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER
    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 nameCARDIOASPIRIN
    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.IMP: 3
    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 FLECTADOL
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS
    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 nameFLECTADOL
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    The condition to be treated is the stroke of “minor” grade (National Institutes of Health Stroke Scale (NIHSS) score < 5).
    La condizione medica oggetto di studio è l’ictus minore (punteggio alla scala NIHSS <5).
    E.1.1.1Medical condition in easily understood language
    A stroke is the rapid loss of brain function(s) due to ischemia, a disturbance in the blood supply to the brain caused by blood vessel thrombosis.
    L’ictus consiste in una rapida perdita di funzioni cerebrali dovuta ad ischemia, un disturbo nell’apporto di sangue al cervello causato da trombosi di un vaso sanguigno.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to demonstrate the reduction in disability (mRS at 90 days: 0-1) in treated patients with “minor” stroke (NIHSS <5 at the time of the decision to treat).

    to demonstrate the safety of rt-PA in minor stroke, investigating overall mortality at day 90, any hemorrhage, symptomatic or not at day 90.
    dimostrare la riduzione della disabilità (mRS a 90 giorni: 0-1) nei pazienti trattati con “minor” stroke (NIHSS <5 al momento della decisione a trattare).
    Dimostrare la sicurezza dello rtPA negli ictus minori, valutando la mortalità e le complicanze emorragiche sintomatiche ed asintomatiche a 90 giorni.
    E.2.2Secondary objectives of the trial
    The secondary objective of the trial is to make a contribution to the empirical European Guidelines for rt-PA treatment which currently recommend treating only patients with an NIHSS score between 5 and 24.
    In caso di risultati positivi, con questo studio ci si propone anche di contribuire a rafforzare l’affermazione finale dell’IST-3 che sostiene non esistano criteri di gravità per l’esclusione dei pazienti dal trattamento, e a modificare le raccomandazioni delle linee guida Europee ed Italiane dell’ictus, che raccomandano il trattamento con rtPA per NIHSS tra 5 e 24.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Acute ischemic stroke;
    • age > 18 years and < 80 years;
    • stroke symptom onset within 4.5 hours before administration of rt-PA;
    • mild stroke with an NIHSS score <5 at admission (stable or improving deficits);
    • written informed consent;
    • unknown onset strokes, with “perfusion/diffusion mismatch” demonstrated by brain perfusion-Computed Tomography o diffusion/perfusion enhanced Magnetic Resonance Imaging.
    • consenso informato scritto
    • ictus ischemico acuto
    • età superiore ai 18 anni ed inferiore ad 80
    • esordio dell’ictus come da approvazione AIFA, entro 4,5 ore dalla somministrazione della terapia in studio
    • esordio non conosciuto, ma valutazione del mismatch mediante TC perfusionale o RM diffusion-perfusion con dimostrazione di un’area ipoperfusa prevalente rispetto al core ischemico
    • punteggio NIHSS < 5 al momento della prima valutazione, sia per deficit stabile, che in remissione
    E.4Principal exclusion criteria
    • intracranial haemorrhage at the CT scan;
    • pregnancy or woman of childbearing age who does not take contraceptives;
    • space occupying mass at the brain CT scan;
    • unknown time of onset;
    • moderate or severe stroke with an NIHSS score of > 5;
    • ASPECT CT brain score > 7;
    • seizure at the onset of stroke with the inability to use PI-TC or RM PI-DWI. Seizures are not exclusion criteria if ischemia is demonstrated by techniques of mismatch.
    • stroke or serious head trauma within the previous 3 months;
    • the administration of heparin within 48 hours preceding the onset of the stroke, with an activated partial-thromboplastin time at presentation exceeding the upper limit for the normal range;
    • platelet count of less than 100,000/mmc;
    • a systolic pressure higher than 185 mmHg or diastolic pressure higher than 110 mmHg that cannot be corrected with appropriate therapy
    • blood glucose level lesser than 50 mg per deciliter or greater than 400 mg per deciliter;
    • symptoms suggestive of subarachnoid haemorrhage, even in the presence of a normal CT brain scan;
    • oral anticoagulant treatment and an INR score > 1.4;
    • major surgery or severe trauma within the previous 3 months;
    • other major disorders known to be associated with an increased risk of bleeding.
    • donne in stato di gravidanza e, qualora in età fertile non facenti uso di terapia contraccettiva efficace
    • patologie espansive evidenziate alla TC
    • emorragia intracranica alla TC
    • tempo d’ esordio non conosciuto
    • ictus moderati o severi con NIHSS > 5
    • ASPECT score alla TC >7
    • crisi epilettiche all’esordio dello ictus, con impossibilità d’ utilizzare PI-TC o RM PI-DWI. Le crisi epilettiche non sono criterio d’esclusione se viene dimostrata l’ischemia mediante le tecniche di mismatch.
    • ictus o grave trauma cranico nei precedenti 3 mesi
    • somministrazione di eparina nelle 48 ore precedenti l’ictus, con aumento del tempo parziale della tromboplastina al di sopra dei limiti di norma al momento della valutazione
    • numero di piastrine inferiore a 100.000/mmc
    • pressione arteriosa sistolica maggiore di 185 e diastolica superiore a 110, non correggibili con opportuna terapia
    • livello ematico del glucosio inferiore a 50 mg/dl o superiore a 400 mg/dl;
    • sintomatologia suggestiva per emorragia subaracnoidea, anche in presenza di TC negativa;
    • trattamento anticoagulante orale con INR > 1,4;
    • trattamenti chirurgici maggiori o trauma grave nei 3 mesi precedenti
    • altri disordini maggiori associati ad un aumentato rischio di sanguinamento
    E.5 End points
    E.5.1Primary end point(s)
    proportion of patients without disability as assessed by an mRS score of 0 or 1 (telephonic interview). The proportion will be calculated on both treated and intention-to treat populations.
    Proporzione di pazienti senza disabilità valutata a 3 mesi dall’insorgenza dell’ictus, mediante intervista telefonica, utilizzando la scala di Rankin modificata (senza disabilità punteggio mRS tra 0 ed 1), sia sulla popolazione intention-to-treat, che sui realmente trattati.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The disability (mRS score) will be assessed at three months.
    La disabilità mediante mRS score sarà valutata a tre mesi
    E.5.2Secondary end point(s)
    • mortality rate from any vascular event,
    • overall mortality rate,
    • incidence of all intracranial hemorrhage and of symptomatic intracranial hemorrhage, total number of intracranial hemorrhage and number of symptomatic brain hemorrhage in the 2 groups; the outcome reported by the physician in charge of the case report will be verified by the Independent Board for the safety of the study, through direct assessment of the neuroradiological documentation.

    • the proportion of patients without any significant disability as assessed by an mRS score of 0 to 2 versus 3 to 6,
    • disability assessed by mRs at three months after stroke,
    • computed as an ordinal variable (shift analysis) on both treated and intention-to treat populations,
    • Barthel Index score > o < 90 at three months.
    • percentuale di mortalità per eventi vascolari
    • mortalità totale
    • N° totale di emorragie intracraniche e N° di emorragie cerebrali sintomatiche nei 2 gruppi; il dato rilevato dal medico responsabile del caso clinico sarà verificato dal comitato indipendente per la sicurezza dello studio, mediante valutazione diretta della documentazione neuroradiologica.
    • disabilità a 3 mesi dall’evento considerata come una variabile ordinale (shiftanalysis), sia sulla popolazione intention-to-treat, che sui realmente trattati.
    • indice di Barthel> o < 90 alla valutazione a 3 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary End Points will be assessed at three months.
    Gli endpoints secondari saranno valutati a tre mesi
    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 Yes
    E.6.13.1Other scope of the trial description
    to make a contribution to the empirical European Guidelines for rt-PA treatment which currently recommend treating only patients with an NIHSS score between 5 and 24.
    contribuire a rafforzare l’affermazione finale dell’IST-3 che sostiene non esistano criteri di gravità per l’esclusione dei pazienti dal trattamento, e a modificare le raccomandazioni delle linee guida Europee ed Italiane dell’ictus, che raccomandano il trattamento con rtPA per NIHSS tra 5 e 24.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned18
    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 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
    LVLS
    ultima visita ultimo soggetto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 No
    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
    acute stroke
    ictus acuto
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state340
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 340
    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)
    After the experimental treatment all patients, in the absence of significant bleeding complications, in the opinion of the phisician, will be treated with aspirin or other antiplatelet agent, and any other drug treatment, care and rehabilitation indicated by scientific evidence and guidelines.
    Dopo il trattamento sperimentale tutti i pazienti, in assenza di rilevanti complicanze emorragiche, a giudizio del medico, verranno sottoposti a trattamento con ASA o altro antiaggregante piastrinico ed a ogni altro trattamento farmacologico, assistenziale e riabilitativo indicato dalle evidenze scientifiche e dalle linee guida.
    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 Decision2013-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-17
    P. End of Trial
    P.End of Trial StatusOngoing
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