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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-000573-80
    Sponsor's Protocol Code Number:201075
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-06
    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 ConcernedSpain - AEMPS
    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-
    Estrategia aleatorizada de Evolocumab frente a tratamiento convencional para
    alcanzar los objetivos buscados de LDL en pacientes que presentan infarto agudo de
    miocardio que lleva a une angioplastia coronaria percutánea inmediata o dentro de
    los 3 días siguientes.
    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-
    Infarto agudo de miocardio destinado a una intervención coronaria percutánea, de forma inmediata (IAMCEST) o en los tres días siguientes (IAMCEST), y aleatorizado a Evolocumab subcutáneo o a estrategias normales para alcanzar los objetivos de las directrices LDL en el mundo real
    - El estudio 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 SponsorAPHP DRCI
    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.4.2CountryEuropean Union
    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 code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0033144841793
    B.5.5Fax number0033144841701
    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 (Repatha®) 140 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    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.3.9.4EV 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 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 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 agudo de miocardio que conduce a una angioplastia coronaria percutánea
    E.1.1.1Medical condition in easily understood language
    Acute myocardial infarction leading to percutaneous coronary angioplasty
    Infarto agudo de miocardio que conduce a una angioplastia coronaria percutánea
    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
    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.
    El objetivo de este estudio es demostrar la superioridad de evolocumab frente al tratamiento estándar para alcanzar una reducción del C-LDL de ≥ 50% desde el inicio y un objetivo de C-LDL de <1,4 mmol/L (<55 mg/dL), a los 12 meses de seguimiento, en la población global.
    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.
    El objetivo secundario de este estudio es demostrar la superioridad de evolocumab frente al tratamiento estándar a la hora de alcanzar una reducción del C-LDL de ≥ 50% desde el inicio y un objetivo de C-LDL de <1,4 mmol/L (<55 mg/dL), a los 12 meses de seguimiento, país por país.
    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
    - Hombre o mujer
    - Diagnóstico de IAMCEST definido como
    o síntomas de IM agudo de al menos 30 min Y
    o en las 24 horas anteriores con nueva elevación persistente del segmento ST ≥1 mm en ≥2 derivaciones continuas del ECG Y
    o una indicación de ICP primaria Y
    o > 55 años
    o
    - Diagnóstico de IAMSEST definido como
    o antecedentes de molestias torácicas o síntomas isquémicos de duración ≥10 minutos en reposo ≤48 horas antes de la entrada en el estudio sin evidencia de elevación persistente del segmento ST y con una troponina elevada (≥ el límite superior de la normalidad según las normas locales de laboratorio), Y
    o indicación de una angiografía coronaria dentro de las 72 horas Y
    o indicación de ICP Y
    o al menos una de las siguientes características de alto riesgo:
    - Diabetes
    - Enfermedad arterial periférica
    - Enfermedad multivaso (≥ 2 o LM) en la angiografía coronaria
    - Antecedentes de IM o ictus sin secuelas antes de la aleatorización
    - TFGe: de 15 a 45 mL/min/1,73 m2 calculado con la fórmula MDRD en el momento de la aleatorización
    - Consentimiento informado obtenido por escrito al inscribirse en el estudio
    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.
    No se incluirá en el estudio a los participantes que presenten alguna de las siguientes características
    - Tratamiento de fibrinolisis
    - CABG planificado
    - Inestabilidad hemodinámica en curso definida como cualquiera de las siguientes:
    o Clase Killip III o IV
    o Hipotensión sostenida y/o sintomática (presión arterial sistólica < 80 mm Hg)
    o Fracción de eyección ventricular izquierda conocida < 30%.
    - Evidencia de enfermedad hepatobiliar grave: disfunción hepática activa actual u obstrucción biliar activa, cirrosis descompensada o hepatitis infecciosa/inflamatoria
    - Enfermedad maligna activa
    - Una enfermedad comórbida con una esperanza de vida estimada de ≤ 12 meses
    - Haber recibido o estar recibiendo evolocumab o cualquier otra terapia para inhibir la PCSK9
    - Sensibilidad conocida a cualquiera de los productos o componentes que se administrarán durante el estudio
    - La mujer está embarazada, tuvo una prueba de embarazo positiva en el momento de la inclusión, está amamantando o planea quedarse embarazada o amamantar durante el tratamiento y durante 17 semanas adicionales después de la última dosis de IMP
    - Actualmente está recibiendo tratamiento en cualquier otro estudio de dispositivos o fármacos en investigación, o hace menos de 30 días que terminó el tratamiento en otro(s) estudio(s) de dispositivos o fármacos en investigación
    - Es probable que el participante no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo, y/o para cumplir con todos los procedimientos requeridos del estudio según el leal saber y entender del participante y del investigador.
    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.
    El criterio de valoración primario es la reducción del C-LDL en ≥ 50% desde el inicio y un C-LDL final de <1,4 mmol/L (<55 mg/dL) a los 12 meses de seguimiento.
    Este criterio de valoración tendrá en cuenta los niveles de LDL-C medidos en el momento de la aleatorización para la línea de base y en la visita final de seguimiento a los 12 meses.
    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.
    Las visitas de seguimiento, incluyendo la medición de LDL-C, se realizarán a las 6, 22 semanas y 12 meses después de la aleatorización. A las 38 semanas, si la medición de LDL-C está disponible, se recogerán los datos.
    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.
    El criterio de valoración secundario es la reducción del C-LDL en ≥ 50% respecto al valor inicial y un C-LDL final de <1,4 mmol/L (<55 mg/dL) a los 12 meses de seguimiento, país por país.
    Se aplicarán las mismas reglas que las anteriores para el criterio de valoración primario.

    Otros criterios de valoración secundarios del control de los lípidos:
    - Reducción del C-LDL de ≥ 50% desde el inicio y objetivo de C-LDL de <1,4 mmol/L (<55 mg/dL) a las 6 y 22 semanas,
    - Porcentaje de cambio en los niveles de LDL-C desde el inicio hasta las 6, 22 semanas y 12 meses,
    - Tiempo para alcanzar el objetivo de LDL-C,
    - Tiempo medio de cambio del C-LDL a lo largo de 12 meses,
    - Cambio desde el inicio en otros parámetros lipídicos (colesterol total, HDL-C, triglicéridos, no-HDL-C) a las 6, 22 semanas y 12 meses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The same rules as above for the primary evaluation criterion will be applied.
    Se aplicarán las mismas reglas que las anteriores para el criterio de evaluación principal.
    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
    sólo el estándar de atención, de acuerdo con las directrices de la 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 concerned5
    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 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
    France
    Poland
    Netherlands
    Spain
    Switzerland
    Germany
    Italy
    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 months19
    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 state175
    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.
    Como Evolocumab (Repatha®) 140 mg ya está aprobado y comercializado como medicamento, el investigador tendrá la opción de prescribir Evolocumab (Repatha®) 140 mg a su paciente para un nuevo curso después de la finalización del ensayo clínico si considera que es la mejor opción para el paciente.
    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 Decision2022-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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