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    Summary
    EudraCT Number:2011-000214-19
    Sponsor's Protocol Code Number:D5130L00006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-20
    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 number2011-000214-19
    A.3Full title of the trial
    A 30 day international, randomized, parallel-group, double-blind, placebo-controlled phase IV study to evaluate efficacy and safety of pre-hospital vs. in-hospital initiation of ticagrelor therapy in STEMI patients planned for PCI
    Studio internazionale randomizzato, a gruppi paralleli, in doppio cieco, controllato verso placebo, di fase III, della durata di 30 giorni, per valutare l’efficacia e la sicurezza del trattamento con ticagrelor con inizio della terapia in fase di pre-ricovero (ambulanza) verso inizio della terapia a ricovero avvenuto, in pazienti STEMI che saranno trattati con PCI primaria.”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 30 day international, randomized, parallel-group, double-blind, placebo-controlled phase IV study to evaluate efficacy and safety of pre-hospital vs. in-hospital initiation of ticagrelor therapy in STEMI patients planned for PCI
    Studio internazionale randomizzato, a gruppi paralleli, in doppio cieco, controllato verso placebo, di fase III, della durata di 30 giorni, per valutare l’efficacia e la sicurezza del trattamento con ticagrelor con inizio della terapia in fase di pre-ricovero (ambulanza) verso inizio della terapia a ricovero avvenuto, in pazienti STEMI che saranno trattati con PCI primaria.”
    A.3.2Name or abbreviated title of the trial where available
    ATLANTIC
    ATLANTIC
    A.4.1Sponsor's protocol code numberD5130L00006
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASTRAZENECA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASTRAZENECA
    B.5.2Functional name of contact pointASTRAZENECA
    B.5.3 Address:
    B.5.3.1Street AddressPALAZZO VOLTA VIA FRANCESCO SFORZA
    B.5.3.2Town/ cityBASIGLIO
    B.5.3.3Post code20800
    B.5.3.4CountryItaly
    B.5.4Telephone number029801 1
    B.5.5Fax number029801 1
    B.5.6E-mailFLORE.LATOUR@ASTRAZENECA.COM
    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 Brilique
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 INNticagrelor
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeAZD6140
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 placeboTablet
    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
    myocardial infarction, STEMI patients planned for Percutaneous Coronary Intervention
    pazienti con infarto del miocardio acuto con elevazione del tratto ST (STEMI) eleggibili per angioplastica primaria (PCI)
    E.1.1.1Medical condition in easily understood language
    myocardial infarction, STEMI patients planned for Percutaneous Coronary Intervention
    pazienti con infarto del miocardio acuto con elevazione del tratto ST (STEMI) eleggibili per angioplastica primaria (PCI)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    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 assess the efficacy of pre-hospital vs. in-hospital initiation of ticagrelor therapy by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment elevation resolution pre-PCI
    Valutare l’efficacia del trattamento con ticagrelor con inizio della terapia in fase pre-ospedaliera verso inizio della terapia in fase ospedaliera comparando la percentuale dei pazienti che raggiungono l’endpoint co-primario di un flusso di grado 3 TIMI di un vaso colpito da IMA all’angiografia primaria o una risoluzione con elevazione pre-PCI ≥ 70% del segmento ST
    E.2.2Secondary objectives of the trial
    •Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during 30 days of treatment •Composite of death, MI, urgent revascularization during 30 days of treatment •Acute stent thrombosis during 30 days of treatment •Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI •Complete (> 70%) ST-segment elevation resolution at 60 min post-PCI •Corrected TIMI frame count, TIMI myocardial perfusion grade at angiography, pre and post PCI. •Time–relationship (from symptom onset to 1st dose intake ) on each co-primary •Time–relationship (from 1st dose intake to ECG/ angiography) on each co-primary •TIMI flow grade 3 at end of procedure Assess the occurrence of major life-threatening bleeding events, other major bleeding events and minor or major bleeding events
    Incidenza combinata di morte, infarto del miocardio, stroke, rivascolarizzazione urgente e trombosi acuta di stent durante i 30 giorni di trattamento. Incidenza combinata di morte, infarto del miocardio, rivascolarizzazione urgente durante i 30 giorni di trattamento.Trombosi acuta di stent durante i 30 giorni di trattamento. Rivascolarizzazione mediante inibitori di glicoproteine IIb/IIIa alla PCI primaria.Completa risoluzione (&gt; 70%) dell’elevazione del tratto ST a 60 minuti post-PCI. Il corretto conteggio dei fotogrammi TIMI (cTFC) all’angiografia, pre e post PCI. Grado di perfusione miocardica TIMI (TMPG) all’angiografia, pre e post PCI. Relazione temporale (dall’inizio dei sintomi all’assunzione della prima dose) per ogni endpoint co-primario. Relazione temporale (dall’assunzione della prima dose all’ECG/angiografia) per ogni endpoint co-primario. Flusso TIMI di grado 3 a fine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult men and women aged 18 years or older. Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile). 2. Symptoms of acute MI of more than 30 min but less than 6 hours 3. New persistent ST-segment elevation ≥ 1 mm in two or more contiguous ECG leads
    1. Firma del consenso informato (versione breve o integrale) in fase di pre-ricovero. Per la natura stessa della patologia target e del disegno dello studio l’ECG qualificante sarà eseguito in fase di pre-ricovero come procedura routinaria prima di ottenere il consenso informato firmato dal paziente. I dati dell’ECG saranno usati per valutare l’eleggibilità del paziente allo studio. 2. Uomini e donne di età ≥ 18 anni. Le pazienti femmine non dovranno essere potenzialmente fertili (da almeno 1 anno in menopausa o chirurgicamente sterili). 3. I sintomi dell’infarto acuto del miocardio dovranno essere di durata di almeno 30 minuti ma inferiore alle 6 ore. 4. Presenza di nuova e persistente elevazione del tratto ST ≥ 1 mm in due o più derivazioni continue.
    E.4Principal exclusion criteria
    1. Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes 2. Contraindication to ticagrelor (refer to SmPC) 3. Concomitant medication that may increase the risk of bleeding [e.g non steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned or administered 24 hours before randomization] 4. Any of the following conditions in the absence of a functioning implanted pacemaker: known SSS, second or third degree AVB, or documented syncope of suspected bradycardic origin. 5. Patients who has received a loading dose for the index event or who are on chronic treatment of prasugrel, clopidogrel or ticagrelor (commercial pack)
    1. Tempo di attesa stimato, dall’ECG qualificante al primo gonfiaggio del palloncino PCI, maggiore di 120 minuti. 2. Versione integrale del consenso informato non firmata prima della somministrazione della prima dose di ticagrelor attivo 90 mg bi giornaliera. 3. Terapia concomitante orale o intravenosa con inibitore forte del citocromo P450 3A (CYP3A) che non può essere interrotta durante il corso dello studio. Inibitori forti: ketoconazolo, itraconazlo, voriconazolo, telitromicina, claritromicina (ma non eritromicina o azitromicina), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, oltre 1 litro al giorno di succo d’ananas). 4. Controindicazioni a ticagrelor (es. ipersensibilità alla sostanza attiva o ad eccipienti, sanguinamenti patologici attivi, storia di precedenti sanguinamenti intracraniali, menomazioni epatiche moderate o severe). 5. Pazienti che hanno ricevuto una dose di carico di clopidogrel, prasugrel o ticagrelor (se in commercio) per l’evento indice o che sono in trattamento cronico con prasugrel, clopidogrel o ticagrelor (se in commercio). 6. Trattamento concomitante che può aumentare il rischio di sanguinamenti (es. farmaci anti infiammatori non steroidei FANS, anticoagulanti orali e/o fibrinolitici, di uso pianificato o somministrato prima delle 24 ore dalla randomizzazione) 7. Intervento chirurgico pianificato durante il periodo di studio 8. Qualcuna delle seguenti condizioni in assenza di pacemaker impiantato funzionante: sindrome del seno malato SSS, AVB di secondo o terzo grado o sincope documentata di sospetta origine bradicardica. 9. Pazienti che necessitano dialisi 10. Trombocitopenia importante clinicamente nota 11. Anemia importante clinicamente nota 12. Condizione di gravidanza o allattamento 13. Condizioni che possono mettere a rischio il paziente o influenzare i risultato dello studio (es. shock cardiogenico o instabilità emodinamica severa, presenza di tumori, rischio di non complicanza, rischio di perdita al follow up). 14. Coinvolgimento attivo nella pianificazione/svolgimento del presente studio (applicabile a impiegati Astrazeneca e/o impiegati al centro partecipante) 15. Precedente randomizzazione nel presente studio 16. Partecipazione in un altro studio clinico interventistico o con device medico nei precedenti 30 giorni.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients reaching TIMI flow grade 3 of MI culprit
    vessel at initial angiography or a ≥70% ST-segment resolution pre PCI
    (co-primary endpoint)
    Percentuale di pazienti che raggiunge un flusso di grado 3 TIMI di un vaso colpito da IMA all’angiografia primaria o risoluzione con elevazione pre-PCI ≥ 70% del segmento ST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    between baseline and PCI
    da baseline alla PCI primaria
    E.5.2Secondary end point(s)
    1. Percentage of patients in the following: composite of death, MI,
    stroke, urgent revascularization and acute stent thrombosis
    2. Percentage of patients presenting an acute stent thrombosis episode
    3. Bleeding events
    a) The total number of patients with major life-threatening bleeding
    events
    b) Total number of patients with other major bleeding events,
    c) Total number of patients with minor or major bleeding events
    1. Percentuale di pazienti soggetti all’evento composito di: morte, infarto del miocardio, stroke, rivascolarizzazione urgente e trombosi acuta di stent durante i 30 giorni di trattamento.
    2. Percentuale di pazienti che presentano trombosi acuta di stent durante i 30 giorni di trattamento.
    3. Eventi di sanguinamento: a) numero di pazienti con eventi di sanguinamento maggiori predisponenti al pericolo di vita; b) numero di pazienti con altri eventi di sanguinamento maggiori; c) numero di pazienti con eventi di sanguinamento maggiori o minori.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. during the 30 days of treatment
    2. during the 30 days of treatment
    3. within the first 48 hours and during 30 days of treatment
    1. durante i 30 gg di trattamento
    2. durante i 30 gg di trattamento
    3. entro le prime 48 h e durante i 30 gg di trattamento.
    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 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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Canada
    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 years0
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1465
    F.4.2.2In the whole clinical trial 1770
    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)
    NA
    NA
    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 Decision2011-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
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