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    Summary
    EudraCT Number:2021-000573-80
    Sponsor's Protocol Code Number:201075
    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:2022-01-26
    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 number2021-000573-80
    A.3Full title of the trial
    Acute Myocardial infarction Upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next three Days (NSTEMI), and randomized to Subcutaneous Evolocumab or Normal strategies to reach guidelines LDL objectives in the real-world – the AMUNDSEN real study
    Strategia randomizzata con evolocumab versus trattamento standard per raggiungere gli obiettivi di LDL su pazienti con infarto acuto del miocardio e con conseguente angioplastica coronarica d'urgenza o entro 3 giorni
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acute Myocardial infarction Upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next three Days (NSTEMI), and randomized to Subcutaneous Evolocumab or Normal strategies to reach guidelines LDL objectives in the real-world
    - The AMUNDSEN-real study-
    Strategia randomizzata con evolocumab versus trattamento di riferimento per raggiungere gli obiettivi di LDL su pazienti con infarto acuto del miocardio e con conseguente angioplastica coronarica d'urgenza o entro 3 giorni – AMUNDSEN-real
    A.3.2Name or abbreviated title of the trial where available
    AMUNDSEN-real
    AMUNDSEN-real
    A.4.1Sponsor's protocol code number201075
    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 SponsorASSITANCE PUBLIQUE DES HOPITAUX DE PARIS
    B.1.3.4CountryFrance
    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 supportAMGEN SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointDamien VANHOYE
    B.5.3 Address:
    B.5.3.1Street Address1 AVENUE CLAUDE VELLEFAUX
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post codePARIS CEDEX 10
    B.5.3.4CountryFrance
    B.5.4Telephone number0033144841793
    B.5.6E-maildamien.vanhoye@aphp.fr
    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 EVOLOCUMAB
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameEvolocumab (Repatha®) 140 mg
    D.3.2Product code [C10AX13]
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNEvolocumab
    D.3.9.1CAS number 1256937-27-5
    D.3.9.2Current sponsor codeREPATHA®
    D.3.9.4EV Substance CodeSUB128552
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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 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.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
    Acute myocardial infarction leading to percutaneous coronary angioplasty
    Infarto miocardico acuto che porta all'angioplastica coronarica percutanea
    E.1.1.1Medical condition in easily understood language
    Acute myocardial infarction leading to percutaneous coronary angioplasty
    Infarto miocardico acuto che porta all'angioplastica coronarica percutanea
    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 purpose of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of = 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL), at 12 months follow-up, in the overall population.
    Dimostrare la superiorità dell’evolocumab versus trattamento standard per ottenere una riduzione del tasso di LDL-C = al 50% in rapporto al tasso iniziale e un tasso di LDL-C < 1,4 mmol/L (<55 mg/dL) nei 12 mesi, su tutta la popolazione sottoposta allo studio.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of = 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL), at 12 months follow-up, country per country
    Dimostrare la superiorità dell’evolocumab versus trattamento standard per ottenere una riduzione del tasso di LDL-C = al 50% in rapporto al tasso iniziale e un tasso di LDL-C < 1,4 mmol/L (<55 mg/dL) nei 12 mesi, per ogni Paese
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female
    - Diagnosis of STEMI defined as:
    o symptoms of acute MI of at least 30 min AND
    o within the previous 24 hours with new persistent ST-segment elevation =1 mm in =2 continuous ECG leads AND
    o an indication for primary PCI AND
    o > 55 years
    or
    - Diagnosis of NSTEMI defined as
    o a history of chest discomfort or ischemic symptoms of =10 minutes duration at rest =48 hours prior to entry into the study with no evidence of persistent ST-segment elevation and with an elevated troponin (= the upper limit of normal according to local laboratory norms), AND
    o indication for a coronary angiogram within 72hrs AND
    o indication for PCI AND
    o at least one the following high-risk characteristics:
    • Diabetes
    • Peripheral Artery Disease
    • Multivessel (= 2 or LM) disease on the coronary angiogram
    • History of MI or stroke without sequels prior to randomization
    • eGFR: 15 to 45 mL/min/1.73 m2 calculated with MDRD formula at randomization
    - Informed consent obtained in writing at enrolment into the study
    Uomo o Donna
    - Che presentino un infarto del miocardio con sopraslivellamento del tratto ST (STEMI) definito da:
    - Sintomi di infarto acuto del miocardio da almeno 30 min. E
    - Elevazione del segmento ST=1 mm in 2 o più derivazioni contigue nelle precedenti 24 ore, E
    - Indicazione di intervento coronarico percutaneo primario, E
    - > 55 anni,
    o,
    - Che presentino un infarto del miocardio con sopraslivellamento del tratto ST (NSTEMI) definito da:
    - Angiografia nelle ultime 72 ore, E
    - Indicazione di intervento coronarico percutaneo, E
    - Che presentino almeno uno tra i seguenti fattori di rischio:
    o Diabete
    o Arteriopatia periferica
    o Coinvolgimento multivascolare (= 2 o tronco comune) confermato da angiografia
    o Precedente infarto del miocardio o AVC senza sequele, prima della randomizzazione
    o Clearance della creatinina eGFR: da 15 a 45 mL/min/1.73 m² calcolata in base alla formula MDMR al momento della randomizzazione
    - Statina a dose massima tollerata nell’ambito della presa in carico standard, al momento della randomizzazione
    - Che abbiano firmato il consenso informato prima di essere inclusi nello studio
    E.4Principal exclusion criteria
    Participant presenting with any of the following will not be included in the study:
    - Fibrinolysis treatment
    - Planned CABG
    - Ongoing hemodynamic instability defined as any of the following:
    o Killip Class III or IV
    o Sustained and/or symptomatic hypotension (systolic blood pressure < 80 mm Hg)
    o Known left ventricular ejection fraction < 30%
    - Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis
    - Active malignancy
    - A comorbid condition with an estimated life expectancy of = 12 months
    - Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
    - Known sensitivity to any of the products or components to be administered during study
    - Female subject is pregnant, had a positive pregnancy test at inclusion, breastfeeding, or planning to become pregnant or breastfeed during treatment and for an additional 17 weeks after the last dose of IMP
    - Currently receiving treatment in any other investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).
    - Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator’s knowledge.
    I soggetti che presentano una tra le seguenti condizioni non saranno inclusi nello studio:
    - Trattamento fibrinolitico
    - Bypass programmato
    - Instabilità emodinamica in corso, definita da o:
    o Killip III o IV
    o Ipotensione sintomatica e/o sostenuta (tensione sistolica <80 mmHg)
    o Frazione di eiezione ventricolare sinistra conosciuta < 30%
    - Evidenza di malattia epatobiliare acuta: disfunzionamento epatico attivo o ostruzione biliare attiva, cirrosi scompensata o epatite infettiva/infiammatoria
    - Tumore attivo
    - Comorbilità che limiti la speranza di vita a meno di 12 mesi
    - Che abbiano assunto o che stiano assumendo evolocumab, o qualunque altro trattamento anti-PCSK9
    - Ipersensibilità conosciuta a uno dei componenti del trattamento allo studio
    - Donne in gravidanza (con test di gravidanza positivo al momento dell’inclusione), che allattino o che prevedano di avere un bambino o di allattare durante il corso del trattamento, e per un periodo di 17 settimane dopo la fine del trattamento allo studio
    - Partecipazione ad altro studio di ricerca biomedica con altri trattamenti sperimentali o dispositivi sperimentali nei 30 giorni precedenti l’inclusione nel presente studio, o già inclusi nello studio stesso
    - Non disponibili e/o non consenzienti per recarsi alle visite di controllo dello studio e per seguire tutte le procedure richieste dallo stesso
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the LDL-C reduction of = 50% from baseline and a final LDL-C of <1.4 mmol/L (<55 mg/dL) at 12 months follow-up.
    This endpoint will consider the LDL-C levels measured at the time of randomization for baseline and at the final 12-months follow-up visit.
    Il criterio di valutazione primario è la riduzione del tasso di LDL-C = al 50% in rapporto al tasso iniziale e un tasso di LDL-C < 1,4 mmol/L, nei 12 mesi del follow-up.
    Questo endpoint terrà conto dei livelli di LDL-C misurati al momento della randomizzazione per il basale e all'ultima visita di follow-up dopo 12 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow-up visits including LDL-C measurement will be performed at 6, 22 weeks and 12 months after randomization. At 38 weeks, if LDL-C measurement is available, the data will be collected.
    i tassi di LDL-C saranno dosati in occasione di visite di controllo a 6 e a 22 settimane, oltre che a 12 mesi dalla randomizzazione.
    (A 38 settimane dalla randomizzazione, solamente nel caso in cui i dati dovessero essere disponibili).
    E.5.2Secondary end point(s)
    The secondary endpoint is LDL-C reduction of = 50% from baseline and a final LDL-C of <1.4 mmol/L (<55 mg/dL) at 12 months follow-up, country by country.
    The same rules as above for the primary endpoint, will apply.

    Other secondary endpoints of lipids control:
    • LDL-C reduction of = 50% from baseline and an LDL-C goal of <1.4 mmol/L (<55 mg/dL) at 6 and 22 weeks,
    • Percent change in levels of LDL-C from baseline to 6, 22 weeks and 12 months,
    • Time to achieve LDL-C target,
    • Time averaged LDL-C change over 12 months,
    • Change from baseline on other lipid parameters (total cholesterol, HDL-C, triglycerides, non-HDL-C) at 6, 22 weeks and 12 months.
    Il criterio secondario è una riduzione = al 50% del tasso di LDL-C in rapporto al tasso iniziale, e un tasso di LDL-C finale < 1,4 mmol/L (<55 mg/dL) nei 12 mesi del follow-up, per ogni Paese.

    Altri criteri di valutazione secondari sui parametri di controllo lipidico:
    • Riduzione del tasso di LDL-C = al 50% in rapporto al tasso iniziale e tasso di LDL-C < 1,4 mmol/L (<55 mg/dL) a 6 e a 22 settimane,
    • Percentuale di variazione del tasso di LDL-C tra il tasso iniziale e quello a 6, 22 settimane e a 12 mesi,
    • Tempistiche per ottenere il tasso LDL-C target,
    • Variazione media del valore di LDL-C nei 12 mesi,
    • Modifica in rapporto al tasso iniziale degli altri parametri lipidici (colesterolo totale, HDL-C, trigliceridi, non-HDL-C) a 6, 22 settimane e a 12 mesi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The same rules as above for the primary evaluation criterion will be applied.
    Saranno applicate le stesse regole di cui sopra per il criterio di valutazione primario.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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
    solo standard di cura, secondo le linee guida ESC/EAS
    standard of care only, according to ESC/EAS guidelines,
    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 EEA87
    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
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    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
    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 months24
    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 months24
    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: 668
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 998
    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 No
    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 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 state163
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1604
    F.4.2.2In the whole clinical trial 1666
    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)
    As Evolocumab (Repatha®) 140 mg is already approved and marketed as a drug, the investigator will have the option of prescribing Evolocumab (Repatha®) 140 mg to his patient for a new course after the end of the clinical trial if he feels this is the best course of action for the patient.
    Poiché Evolocumab (Repatha®) 140 mg sono già approvati e commercializzati come farmaco, lo sperimentatore avrà la possibilità di prescrivere Evolocumab (Repatha®) 140 mg al suo paziente per un nuovo corso dopo la fine dello studio clinico se ritiene che sia la migliore linea d'azione per il paziente.
    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 Decision2022-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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