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    Summary
    EudraCT Number:2014-004486-25
    Sponsor's Protocol Code Number:GSH2014
    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:2014-12-04
    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 number2014-004486-25
    A.3Full title of the trial
    Prevention of the reperfusion myocardical damage in patients with acute myocardial infarct submitted to primary PCI through infusion of 'glutatione sale sodico' ev.
    Prevenzione del danno miocardico da riperfusione nei pazienti con infarto miocardico acuto candidati ad angioplastica primaria mediante infusione di glutatione sale sodico ev.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of the reperfusion myocardical damage in patients with acute myocardial infarct submitted to primary PCI through infusion of 'glutatione sale sodico' ev.
    Prevenzione del danno miocardico da riperfusione nei pazienti con infarto miocardico acuto candidati ad angioplastica primaria mediante infusione di glutatione sale sodico ev.
    A.4.1Sponsor's protocol code numberGSH2014
    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 SponsorUniversity Hospital Policlinico Umberto I
    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 supportUniversity Hospital Policlinico Umberto I
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Policlinico Umberto I
    B.5.2Functional name of contact pointEnrico Mangieri
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico, 155
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.6E-mailenrico.mangieri@uniroma1.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 TAD
    D.2.1.1.2Name of the Marketing Authorisation holderBiomedica Foscama Group 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.3.4Pharmaceutical 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute myocardial infarct
    infarto acuto del miocardio
    E.1.1.1Medical condition in easily understood language
    acute myocardial infarct
    infarto acuto del miocardio
    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 verify if the intravenous infusion of “glutatione sale sodico” it is able to reduce the level of oxidative state in the area of myocardial infarction.
    Verificare se l’infusione endovenosa di glutatione sale sodico è in grado di ridurre il livello dello stato ossidativo nell’ area miocardica infartuale.
    E.2.2Secondary objectives of the trial
    To verify if the intravenous infusion of “glutatione sale sodico” during the procedures of primary PCI it is able to limit the extension of the ischemic area, to reduce the incidence of the no-reflow, to improve the degree of myocardial blush and to decrease the indexes of suffering post-procedural ischemia (ST elevation; release of myocardial necrosi markers).
    Verificare se l’infusione endovenosa di glutatione sale sodico effettuata durante le procedure di angioplastica primaria è in grado di limitare l’estensione dell’area ischemica, di ridurre l’incidenza del no-reflow, di migliorare il grado di perfusione miocardica (blush) e di diminuire gli indici di sofferenza ischemica post-procedurale (sopraslivellamento tratto ST; rilascio di enzimi miocardiospecifici).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ACS in patients submitted to p-PCI up to 12 hours
    Age≥18 years
    Women and Men
    Signed informed consent
    Pazienti con SCA di durata ≤ 12 ore ed indicazione ad eseguire p-PCI;
    Età≥18 anni
    Donne e Uomini
    Consenso informato scritto firmato.
    E.4Principal exclusion criteria
    Patients with cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous acute myocardial infarction, or angina within 48 hours before infarction were not included in the study.
    Patients with evidence of coronary collaterals (2-3 Rentrop) to the region at risk on initial coronary angiography (at the time of admission) will be excluded.
    Patients with EF ≤ 30%
    The patient has impaired renal function (creatinine > 3.0 mg/dl);
    The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, contrast media or stainless steel that cannot be managed medically;
    The patient needs therapy with warfarin;
    The patient has a life expectancy less than 12 months;
    Recipient of heart transplant;
    The patient is currently participating in an investigational drug or another device study.
    Pazienti con arresto cardiaco, fibrillazione ventricolare, shock cardiogeno, trombosi intrastent, precedente IMA;
    Presenza di circolo collaterale (Rentrop 2/3) diretto alla regione miocardica perfusa dall’ arteria responsabile dell’infarto;
    Presenza dell’occlusione target all’interno di un segmento precedentemente sottoposto a posizionamento di stent;
    Presenza all’interno dello stesso vaso di altre lesioni, che richiedano un intervento di angioplastica e non possano essere trattate con lo(gli) stesso/i stent usato/i per l’occlusione target;
    Pazienti con frazione di eiezione uguale od inferiore al 30%;
    Pazienti con funzionalità renale compromessa (creatinina > 3.0 mg/dl);
    Pazienti con una riconosciuta allergia all’aspirina, alle thienopiridine, all’eparina, a mezzi di contrasto o metalli pesanti che non possono essere gestite medicalmente;
    Pazienti che necessitano di terapia con warfarin;
    Pazienti con un’aspettativa di vita inferiore a 12 mesi;
    Pazienti che hanno ricevuto un trapianto di cuore;
    Pazienti che stiano già partecipando ad altro studio, sia farmacologico che di altro tipo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endopoint will consist in the assessment of the effects of the infusion of “glutatione sale sodico” on the reduction of the oxidative markers and inflammation after PCI
    L’endopoint primario consisterà nella valutazione degli effetti dell’infusione di glutatione sui marker di stress ossidativo e di infiammazione dopo PCI
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 6 months
    Fino a 6 mesi
    E.5.2Secondary end point(s)
    The secondary endopoint will include:
    1) the assessment of the variations of the corrected TIMI frame count (cTFC) and the TIMI Myocardial Perfusion Grade (TMPG) after PCI;
    2) the assessment of the middle values of peak of the cardiac Troponin, after the procedure;
    3) To verify,through telephone contact or a programmed visit, the principal adverse clinical events as death, acute myocardial infarct, stent's thrombosis of the treated vessels or the occurence of a new revascularization, up to 6 months after the procedure.
    Medical Doctors don't have the knowledge both about the possible infusion of the glutatione ev, in the examined patient, than others clinical data.

    Moreover, sierological levels of Troponin and creatinine will be measured before the PCI and after the procedure (2, 6, 12 and 24 hours).
    Besides, through 2D Echocardiography with Simpson's biplane method the FE will be calculate at admission and after hospital discarge.
    In the case in which clinical-instrumental signs of ischemia will rise up patient will be submit to a new angrography.
    Gli endopoints secondari includeranno:
    1) la valutazione delle variazioni del cTFC e del TMPG dopo PCI (Core lab – Vedi appendice 1).
    2) la valutazione dei valori medi di picco della Troponina cardiaca dopo la procedura;
    3) la registrazione dei principali eventi clinici avversi definiti come l’insieme di morte, infarto acuto del miocardio, trombosi dello stent e nuova rivascolarizzazione del vaso target fino a 6 mesi dopo l’intervento verificato tramite contatto telefonico o visite programmate dagli operatori che non a conoscenza della assegnazione al trattamento al momento dell’esecuzione della PCI e di qualunque dato clinico, laboratoristico e angiografico.
    Unitamente alla troponina i livelli di creatinina sierica saranno misurati prima della PCI e a distanza di 2 ore e poi 6, 12 e 24 ore dopo la procedura. Inoltre, tramite Ecocardiografia 2D con metodica Simpson si raccoglieranno dati della FE all'ingresso e prima della dimissione ospedaliera.
    Nel caso in cui insorgeranno segni clinico-strumentali di ischemia verrà eseguita una nuova valutazione angiografica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 6 months
    Fino a 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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) 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 concerned3
    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 No
    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 or telephonic contact
    LVLS o contatto telefonico
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 2014-12-04. 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 state90
    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
    Nessuno
    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 Decision2015-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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