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    Summary
    EudraCT Number:2020-000983-41
    Sponsor's Protocol Code Number:ID-076A301
    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:2021-09-28
    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 number2020-000983-41
    A.3Full title of the trial
    Multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction
    Studio multicentrico, in doppio cieco, randomizzato, controllato con placebo, a gruppi paralleli per valutare l'efficacia e la sicurezza di selatogrel autosomministrato sottocute, per la prevenzione della mortalità e il trattamento dell'infarto miocardico acuto in soggetti con storia recente di infarto miocardico acuto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
    Studio su Selatogrel nel trattamento dell'infarto miocardico acuto
    A.3.2Name or abbreviated title of the trial where available
    SOS-AMI
    SOS-AMI
    A.4.1Sponsor's protocol code numberID-076A301
    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 SponsorIDORSIA PHARMACEUTICALS LTD
    B.1.3.4CountrySwitzerland
    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 supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041588441799
    B.5.5Fax number0041588440108
    B.5.6E-mailclinical-trials-disclosure@idorsia.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 No
    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 nameSelatogrel
    D.3.2Product code [ACT-246475]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSelatogrel
    D.3.9.2Current sponsor codeACT-246475
    D.3.9.4EV Substance CodeSUB198076
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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 Yes
    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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute myocardial infarction
    Infarto miocardico acuto
    E.1.1.1Medical condition in easily understood language
    Heart attack
    Infarto
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute 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
    The primary objective of the study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI
    L’obiettivo primario dello studio è valutare l’efficacia clinica di selatogrel quando autosomministrato alla comparsa di sintomi suggestivi di infarto miocardico acuto (IMA) in soggetti a rischio di episodi ricorrenti di IMA
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety of self-administration of selatogrel.
    L’obiettivo secondario è valutare la sicurezza dell’autosomministrazione di selatogrel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated informed consent prior to any study-mandated procedure
    • Male or female subject = 18 years old at the time of signing the informed consent form
    • Discharged with a confirmed diagnosis of symptomatic Type 1 acute myocardial infarction ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI), no longer than 4 weeks prior to randomization
    • Presence of either a second prior AMI within 1 year of screening or at least 2 of the following risk factors:
    - Second prior AMI more than 1 year before screening,
    - Diabetes mellitus defined by ongoing glucose lowering treatment,
    - Chronic kidney disease with estimated glomerular filtration rate less than 60 mL/min/1.73 m2,
    - Multivessel coronary artery disease,
    - Peripheral artery disease,
    - Age greater than or equal to 65 years,
    - Absence of coronary revascularization of the qualifying AMI,
    - Active daily smoking at screening.
    • Successfully self-administered placebo according to the autoinjector Instructions for use during screening
    • Modulo di consenso informato firmato e datato prima di qualsiasi procedura richiesta dallo studio
    • Soggetto maschio o femmina = 18 anni al momento di firmare il consenso informato
    • Dimissione con diagnosi confermata di IMA sintomatico di tipo 1 (STEMI o NSTEMI2), non più di 4 settimane prima della randomizzazione
    • Presenza di un secondo IMA nell'anno precedente lo screening o di almeno 2 dei seguenti fattori di rischio:
    a. Secondo IMA nell'anno precedente lo screening.
    b. Diabete mellito con terapia ipoglicemizzante continua.
    c. Malattia renale cronica con velocità di filtrazione glomerulare stimata < 60 ml/min/1,73 m2.
    d. Malattia coronarica multivasale
    e. Arteriopatia periferica
    f. Età = 65 anni
    g. Assenza di rivascolarizzazione coronarica dell'IMA
    h. Fumatore quotidiano attivo allo screening
    • Corretta autosomministrazione del placebo secondo le istruzioni per l’uso dell’autoiniettore durante lo screening.
    E.4Principal exclusion criteria
    • Increased risk of serious bleeding including any of the following:
    - History of intracranial bleed at any time.
    - Known uncorrected intracranial vascular abnormality.
    - Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening.
    - Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
    - Known liver impairment significantly affecting the hepatic function.
    - Current dialysis.
    - Ischemic stroke or transient ischemic attack within 3 months of screening.
    • Chronic anemia with hemoglobin < 10 g/dL.
    • Chronic thrombocytopenia with platelet count < 100,000/mm3.
    • Concomitant diseases or conditions that, in the opinion of the investigator, are not compatible with study participation.
    • Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
    • Previous exposure to an investigational drug within 3 months prior to randomization.
    • Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.
    • Aumentato rischio di sanguinamento grave, compresa una qualsiasi delle seguenti condizioni:
    a. Storia di emorragia intracranica.
    b. Anomalia vascolare intracranica nota non corretta.
    c. Sanguinamento gastrointestinale che ha richiesto ricovero o trasfusione nell'anno precedente lo screening.
    d. Soggetti trattati con triplice terapia antitrombotica orale (ovvero doppia terapia antiaggregante e anticoagulante orale).
    e. Compromissione epatica nota che influisce significativamente sulla funzionalità epatica
    f. Dialisi in corso.
    g. Ictus ischemico o attacco ischemico transitorio nei 3 mesi precedenti lo screening.
    • Anemia cronica con emoglobina < 10 g/dl.
    • Trombocitopenia cronica con conta piastrinica < 100.000/mm3.
    • Malattie concomitanti o condizioni concomitanti che, a giudizio dello sperimentatore, non sono compatibili con la partecipazione allo studio.
    • Ipersensibilità nota a selatogrel, a uno qualsiasi degli eccipienti o ai farmaci della classe P2Y12.
    • Esposizione a un farmaco sperimentale nei 3 mesi precedenti la randomizzazione.
    • Partecipazione a un altro studio clinico con un prodotto o un dispositivo sperimentale nei 3 mesi precedenti la randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    • The primary efficacy endpoint is defined as the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration.
    The outcomes will be ranked based on severity, from the most severe to the least severe outcome, as follows:
    1. Death (all causes).
    2. AMI with compromised electro-hemodynamics.
    3. STEMI.
    4. High-risk NSTEMI.
    5. NSTEMI with peak Cardiac troponin (cTn) > 10 × (upper limit of normal) ULN.
    6. None of the above.
    The Clinical Event Committee (CEC) will adjudicate all events in a blinded manner.
    Each outcome will be assessed after each study treatment administration and, for each subject, only the worst outcome will be retained as a primary endpoint.

    • The primary safety endpoint is the occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition.
    • L’endpoint primario di efficacia è definito come l’insorgenza della morte per qualsiasi causa o di IMA non fatale dopo un’autosomministrazione del trattamento in studio1.
    Gli esiti saranno classificati in base alla gravità, da quello più grave a quello meno grave, come segue:
    1. Morte (per qualsiasi causa)
    2. IMA con compromissione elettroemodinamica
    3. Infarto miocardico con sopraslivellamento del tratto ST (STEMI)
    4. Non-STEMI ad alto rischio (NSTEMI)
    5. NSTEMI con cTn di picco > 10 volte il limite superiore della norma (ULN)
    6. Nessuna delle condizioni precedenti
    Il Clinical Event Committee (comitato per la valutazione degli eventi clinici, CEC) giudicherà tutti gli eventi in cieco.
    Ogni esito sarà valutato dopo ogni somministrazione del trattamento in studio. Per ciascun soggetto, l’esito più grave sarà considerato come endpoint primario.

    • L'endpoint primario di sicurezza è l'Insorgenza di eventi di sanguinamento dovuti al trattamento di tipo 3 o 5 secondo la classificazione del Bleeding Academic Research Consortium (BARC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Primary efficacy endpoint:
    Outcome 1, i.e. death (all causes) within 7 days after study treatment administration.
    Outcomes 2,3,4,5, and 6 within 2 days after any study treatment administration.

    • Primary safety endpoint within 2 days after any study treatment administration.
    • Endpoint primario di efficacia:
    Esito 1, ovvero morte (per qualsiasi causa) l causes) entro 7 giorni dalla somministrazione del trattamento in studio.
    Esiti 2,3,4,5 e 6 entro 2 giorni dalla somministrazione del trattamento in studio.

    • Endpoint primario di sicurezza:
    entro 2 giorni dalla somministrazione del trattamento in studio.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint is a composite of death from all causes, non-fatal AMI, or hospitalization or unplanned visit to emergency department for heart failure.
    L’endpoint secondario è un parametro composito di morte per qualsiasi causa, IMA non fatale oppure ospedalizzazione o ricovero non programmato in medicina d'urgenza per insufficienza cardiaca entro 30 giorni dalla somministrazione del trattamento in studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 30 days after any study treatment administration
    Entro 30 giorni dalla somministrazione del trattamento in studio.
    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 Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA135
    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 Information not present in EudraCT
    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
    Israel
    Serbia
    United States
    Austria
    Belgium
    Bulgaria
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Lithuania
    Netherlands
    Norway
    Poland
    Romania
    Slovakia
    Spain
    Switzerland
    United Kingdom
    Czechia
    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
    Last Subject Last Visit
    LVLS
    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 months6
    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 months6
    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: 5600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8400
    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 state448
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7000
    F.4.2.2In the whole clinical trial 14000
    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)
    Subject's will be treated in accordance with the standard-of-care during and after participation in the trial.
    I soggetti verranno trattati secondo normale pratica clinica durante e al termine dello studio
    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 Decision2021-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-18
    P. End of Trial
    P.End of Trial StatusOngoing
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