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    Summary
    EudraCT Number:2010-021258-20
    Sponsor's Protocol Code Number:EAST
    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:2012-09-26
    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 number2010-021258-20
    A.3Full title of the trial
    Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST)
    Trattamento precoce di fibrillazione atriale per la prevenzione dell'ictus cerebrale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to demonstrate that an early as possible treatment of atrial fibrillation can prevent a stroke.
    Studio clinico finalizzato a dimostrare che un trattamento il piu' precoce possibile della fibrillazione atriale puo' prevenire l’ictus.
    A.3.2Name or abbreviated title of the trial where available
    EAST
    EAST
    A.4.1Sponsor's protocol code numberEAST
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN04708680
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01288352
    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 SponsorKOMPETENZNETZ VORHOFFLIMMERN E.V. (AFNET)
    B.1.3.4CountryGermany
    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 supportKompetenznetz Vorhofflimmern e.V. (AFNET)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKompetenznetz Vorhofflimmern e.V. (AFNET)
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressALBERT-SCHWEITZER-CAMPUS 1 / GEBAEUDE D11, DOMAGKSTR. 11
    B.5.3.2Town/ cityMuenster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number0049 251 8345340
    B.5.5Fax number0049 251 8345343
    B.5.6E-maileast@ukmuenster.de
    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.2.1.2Country 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 Tablet
    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 INNAMIODARONE HYDROCHLORIDE
    D.3.9.1CAS number 19774-82-4
    D.3.9.4EV Substance CodeSUB00472MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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 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.2.1.2Country 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 Tablet
    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 INNFLECAINIDE ACETATE
    D.3.9.1CAS number 54143-56-5
    D.3.9.4EV Substance CodeSUB13894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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 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.2.1.2Country 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 Film-coated tablet
    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 INNPROPAFENONE HYDROCHLORIDE
    D.3.9.1CAS number 34183-22-7
    D.3.9.4EV Substance CodeSUB04077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number300
    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: 4
    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.2.1.2Country 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 Film-coated tablet
    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 INNDRONEDARONE HYDROCHLORIDE
    D.3.9.1CAS number 141625-93-6
    D.3.9.4EV Substance CodeSUB28992
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number400
    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
    Atrial fibrillation, stroke, heart failure, myocardial infarction, cognitive dysfunction
    Fibrillazione atriale, ictus, insufficienza cardiaca, infarto del miocardio, disfunzione cognitiva
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation is a common type of cardiac rhythm disorder, which represents an important cause for stroke but also for myocardial infarction and heart muscle weakness (heart failure).
    La fibrillazione atriale è un diffuso disturbo del ritmo cardiaco, che rappresenta un’importante causa di ictus, ma anche di infarto del miocardio e debolezza del muscolo cardiaco.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level HLGT
    E.1.2Classification code 10019280
    E.1.2Term Heart failures
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test whether an early, comprehensive, rhythm control therapy can prevent adverse cardiovascular outcomes in patients with recent-onset atrial fibrillation (AF) compared to usual care
    Il presente Studio mira a verificare se una terapia precoce di controllo del ritmo sia in grado di prevenire gravi complicanze cardiovascolari in pazienti con recente diagnosi di fibrillazione atriale (FA). Il trattamento precoce viene confrontato con la attuale terapia convenzionale (“usual care”).
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following main criteria must be present for eligibility into the study: Recent onset AF, i.e. AF with a known history of ≤1 year prior to randomisation; Risk for stroke as evidenced by EITHER a) one of the following: age > 75 years, prior stroke or transient ischemic attack (TIA) OR b) two of the following: hypertension, diabetes mellitus, left ventricular hypertrophy, age > 65 years, female sex, peripheral artery disease, kidney disease (MDRD stage III or IV), stable heart failure (NYHA II or LVEF <50%), severe coronary artery disease (previous myocardial infarction, CABG or PCI)
    Ai fini dell’inclusione nello Studio devono essere soddisfatti i seguenti requisiti: 1. Diagnosi di fibrillazione atriale inferiore a un anno (recente diagnosi di fibrillazione atriale) e 2. Presenza di fattori di rischio di ictus, precisamente: a) uno dei seguenti fattori di rischio: Età &gt; 75 anni, ictus pregresso o attacchi ischemici transitori (TIA) o b) due dei seguenti fattori di rischio: ipertensione, diabete mellito, ipertrofia ventricolare sinistra, età &gt; 65 anni, sesso femminile, arteriopatia aterosclerotica periferica, insufficienza renale (MDRD Stadio III o IV), insufficienza cardiaca stabile (NYHA II o LVEF &lt; 50%), grave coronaropatia (infarto pregresso del miocardio, Bypass coronarico o PCI)
    E.4Principal exclusion criteria
    1. Any disease that limits life expectancy to less than 1 year. 2. Participation in another clinical trial, either within the past two months or ongoing 3. Previous participation in the EAST trial. 4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized. 5. Breastfeeding women. 6. Drug abuse. 7. Prior AF ablation or surgical therapy of AF. 8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone. 9. Patients not suitable for rhythm control of AF. 10. Severe mitral valve stenosis. 11. Prosthetic mitral valve. 12. Clinically relevant hepatic dysfunction requiring specific therapy. 13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled. 14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis)
    1. Qualsiasi malattia con aspettativa di vita inferiore ad 1 anno; 2. Partecipazione antecedente o in corso (entro gli ultimi due mesi) ad un altro studio clinico; 3. Precedente partecipazione allo studio EAST; 4. Le donne in gravidanza o in età fertile senza contraccezione adeguata: solo le donne con un metodo contraccettivo molto efficace [contraccettivi orali o IUD] o sterili possono essere randomizzate); 5. Donne che allattano; 6. Abuso di farmaci; 7. Precedente ablazione di FA o precedente terapia chirurgica di FA; 8. Precedente fallimento della terapia con amiodarone (per esempio, pazienti con fibrillazione atriale recidiva sintomatica che ha richiesto una escalation in terapia con Amiodarone); 9. Pazienti ai quali non si adatta il trattamento di mantenimento del ritmo di FA; 10. Grave stenosi della valvola mitralica; 11. Storico protesica valvola mitrale; 12. Disfunzione epatica clinicamente rilevante che richiede una terapia specifica; 13. Disfunzione tiroidea clinicamente manifesta. Dopo i risultati soddisfacenti conseguiti con il trattamento di disfunzione della tiroide, il paziente può essere randomizzato; 14. Grave disfunzione renale (Stadio V, probabile dialisi o probabilmente già in corso).
    E.5 End points
    E.5.1Primary end point(s)
    A composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome. The 1st co-primary outcome parameter is defined as the time to the first occurrence of a composite of the above mentioned components. The 2nd co-primary outcome is nights spent in hospital per year.
    Una combinazione di decesso per evento cardiovascolare, ictus / attacco ischemico transitorio e ricovero ospedaliero per cardiaca scompenso cardiaco o sindrome coronarica acuta. Il 1° end-point co-primario è definito come periodo fino alla prima insorgenza dei sopra citati eventi. Il 2° end-point co-primario è il numero di notti trascorse in ospedale nell’anno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    A first interim analysis is to be performed when the first 171 events in the 1st co-primary outcome have been observed. If the assumptions are met, this will happen 32 months after the first patient was randomized. The second interim analysis is to be performed when the first 343 events in the 1st co-primary outcome have been observed (approximately 47 months after the first patient was randomized). The third interim analysis is to be performed when the first 514 events have been observed (approximately 59 (11) months after the first (last) patient was randomized). The final analysis is to be performed when 685 events have been observed. If the assumptions are met, this will happen 72 (24) months after the first (last) patient was randomized.
    Una prima analisi ad interim dovrà essere eseguita all’avvenuta osservazione dei primi 171 eventi del primo end-point co-primario. Se le ipotesi sono confermate, ciò accadrà 32 mesi dopo la randomizzazione del primo paziente. La seconda analisi ad interim dovrà essere eseguita all’avvenuta osservazione dei primi 343 eventi del primo end-point co-primario (circa 47 mesi dopo la randomizzazione del primo paziente). La terza analisi ad interim dovrà essere eseguita all’avvenuta osservazione dei primi 514 eventi (circa 59 (11) mesi dopo la randomizzazione del primo (ultimo) paziente). L’analisi finale dovrà essere eseguita all’avvenuta osservazione di 685 eventi. Se le ipotesi sono confermate, ciò accadrà 72 (24) mesi dopo la randomizzazione del primo (ultimo) paziente.
    E.5.2Secondary end point(s)
    1. Cardiovascular death 2. stroke 3. worsening of heart failure assessed by hospitalizations 4. acute coronary syndrome assessed by hospitalizations 5. time to recurrent atrial fibrillation 6. cardiovascular hospitalisations 7. all-cause hospitalisations 8. left ventricular function assessed by transthoracic echocardiography 9. quality of life changes assessed by EQ-5D and SF-12 10. cognitive function assessed by MoCA
    1. Decesso per evento cardiovascolare 2. Ictus 3. Peggioramento dell’insufficienza cardiaca accertato mediante ricovero ospedaliero 4. Sindrome coronarica acuta accertata mediante ricovero ospedaliero 5. Periodo intercorrente tra le recidive di fibrillazione atriale 6. Ricoveri ospedalieri per eventi cardiovascolari 7. Ricoveri ospedalieri per altre cause 8. Funzionalità ventricolare sinistra accertata mediante ecocardiografia transtoracica 9. Qualità di vita accertata mediante EQ-5D e SF-12 10. Funzione cognitiva accertata mediante MoCA test
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of secondary end points no. 1-7 at the end of the trial (i.e. after 6 years). Evaluation of secondary end points no. 8-10 at month 24 after randomisation.
    Analisi degli end-point secondari 1-7 al completamento dello Studio (cioè dopo 6 anni). Analisi degli end-point secondary 8-10 al mese 24 successivo alla randomizzazione.
    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 No
    E.6.5Efficacy No
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia standard conform. alle attuali Linee ESC
    usual care as defined by the current ESC guideline
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA192
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    Switzerland
    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
    EAST is an event-driven trial. The final analysis will be performed if 685 events in the 1st co-primary outcome have been observed. If the statistical assumptions are met, this will happen 6 years after the first patient has been randomised in the study.
    Studio EAST è basato sugli eventi. L’analisi finale sarà eseguita all’avvenuta osservazione di 685 eventi del primo end-point co-primario. Se sono confermati i requisiti statistici, il completamento avverrà 6 anni dopo la randomiz. del primo pazient
    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 months62
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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.1.1Number of subjects for this age range: 0
    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: 810
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    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 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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2660
    F.4.2.2In the whole clinical trial 2810
    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)
    All medications and treatments applied during the EAST study are inline therapies approved by health authorities and marketed. They are used in line with European approval and in line with the current guidelines. The patients' treatment after termination of the study participation will be decided by the responsible investigator and will be in accordance with local clinical routine.
    Tutti i farmaci e i trattamenti applicati durante lo Studio EAST sono terapie inline approvate dalle Autorità sanitarie competenti e in commercio. Il loro utilizzo è stato approvato dalle Autorità europee competenti e in linea con le direttive vigenti. La decisione sul trattamento dei pazienti al termine dello Studio spetta al Medico Sperimentatore Responsabile conformemente alla pratica clinica locale.
    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 Decision2012-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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