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    Summary
    EudraCT Number:2021-000573-80
    Sponsor's Protocol Code Number:APHP201075
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-07
    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 ConcernedGermany - PEI
    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-
    Randomisierte Strategie mit Evolocumab im Vergleich zur Referenztherapie zur Erreichung von LDL-Zielen bei Patienten mit akutem Myokardinfarkt, bei denen sofort oder innerhalb von 3 Tagen eine perkutane koronare Angioplastie durchgeführt wird.
    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-
    Randomisierte Strategie mit Evolocumab im Vergleich zur Referenztherapie zur Erreichung von LDL-Zielen bei Patienten mit akutem Myokardinfarkt, bei denen sofort oder innerhalb von 3 Tagen eine perkutane koronare Angioplastie durchgeführt wird - AMUNDSEN-real
    A.4.1Sponsor's protocol code numberAPHP201075
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP DRCI
    B.5.2Functional name of contact pointVANHOYE Damien
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude VEllfaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    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.3.9.4EV 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
    E.1.1.1Medical condition in easily understood language
    Acute myocardial infarction leading to percutaneous coronary angioplasty
    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.
    Nachweis der Überlegenheit von Evolocumab gegenüber der Standardtherapie hinsichtlich einer Senkung des LDL-C-Wertes um ≥ 50 % gegenüber dem Ausgangswert und eines LDL-C-Wertes < 1,4 mmol/L (<55 mg/dL) nach 12 Monaten in der gesamten Studienpopulation.
    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.
    Nachweis der Überlegenheit von Evolucumab gegenüber der Standardtherapie in Bezug auf das Erreichen einer Senkung des LDL-C-Wertes um ≥50 % gegenüber dem Ausgangswert und eines LDL-C-Wertes < 1,4 mmol/L (<55 mg/dL) nach 12 Monaten auf einer länderspezifischen Basis.
    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
    - Männlich oder weiblich
    - Vorliegen eines Myokardinfarkts mit ST-Segment-Hebung (STEMI), definiert als:
    - Symptome eines akuten Myokardinfarkts über mindestens 30 Minuten, UND
    - ST-Segment-Hebung ≥1 mm in 2 oder mehr zusammenhängenden Ableitungen innerhalb der letzten 24 Stunden, UND
    - Indikation für primäre perkutane Koronarintervention, UND
    - > 55 Jahre,
    oder
    - Vorliegen eines Myokardinfarkts ohne ST-Segment-Hebung (NSTEMI), definiert durch:
    - Durchführung einer Angiographie innerhalb von 72 Stunden, UND
    - Indikation für eine primäre perkutane Koronarintervention, UND
    - Aufweisen von mindestens einem der folgenden Risikofaktoren:
    o Diabetes
    o Periphere Arterienerkrankung
    o Angiografisch bestätigte multitrunkuläre Erkrankung (≥ 2 oder gemeinsamer Stamm)
    o Vorheriger Herzinfarkt oder Schlaganfall ohne Folgeerscheinungen vor der Randomisierung
    o Kreatinin-Clearance eGFR: 15 bis 45 mL/min/1,73 m², berechnet nach der MDRD-Formel bei der Randomisierung
    - Statin in maximal verträglicher Dosis bei Standardbehandlung zum Zeitpunkt der Randomisierung
    - Unterzeichnung der Einverständniserklärung vor der Teilnahme an der Studie
    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.
    Probanden mit einer der folgenden Erkrankungen werden nicht in die Studie aufgenommen:
    - Fibrinolytische Behandlung
    - Programmierte Bypassoperation
    - Fortbestehende hämodynamische Instabilität, definiert als:
    o Killip III oder IV
    o Symptomatische und/oder anhaltende Hypotonie (systolischer Druck <80 mmHg)
    o Bekannte linksventrikuläre Ejektionsfraktion < 30%
    - Anzeichen einer schweren hepatobiliären Erkrankung: aktive Leberfunktionsstörung oder aktive biliäre Obstruktion, dekompensierte Zirrhose oder infektiöse/entzündliche Hepatitis
    - Aktive Krebserkrankung
    - Komorbidität, die die Lebenserwartung auf weniger als 12 Monate begrenzt
    - Zuvor Evolocumab oder eine andere Anti-PCSK9-Therapie erhalten haben oder erhalten
    - Bekannte Überempfindlichkeit gegen einen Bestandteil der Studienbehandlung
    - Schwangere (mit positivem Schwangerschaftstest zum Zeitpunkt der Studienaufnahme), die stillen oder planen, während der Behandlung und für einen Zeitraum von 17 Wochen nach Beendigung der Studienbehandlung Kinder zu bekommen oder zu stillen
    - Teilnahme an einer anderen biomedizinischen Forschungsstudie mit anderen experimentellen Behandlungen oder Geräten innerhalb von 30 Tagen vor Aufnahme in diese Studie oder bereits in die Studie aufgenommen
    - Nicht verfügbar und/oder nicht bereit, zu den Nachuntersuchungen der Studie zu kommen und alle für die Studie erforderlichen Verfahren einzuhalten.
    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.
    Die primäre Bewertungskriterie ist eine Senkung des LDL-C-Wertes um ≥ 50 % gegenüber dem Ausgangswert und ein LDL-C-Wert < 1,4 mmol/L bei einer Nachbeobachtung von 12 Monaten.
    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.
    In ähnlicher Weise werden die LDL-C-Werte bei Nachuntersuchungen 6 und 22 Wochen sowie 12 Monate nach der Randomisierung ermittelt.
    (38 Wochen nach der Randomisierung, nur wenn Daten verfügbar sind).
    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.
    Die sekundäre Bewertungskriterie ist eine Senkung des LDL-C-Wertes um ≥ 50 % gegenüber dem Ausgangswert und ein endgültiger LDL-C-Wert <1,4 mmol / L (<55 mg / dL) bei der Nachbeobachtung nach 12 Monaten, Land für Land.

    Andere sekundäre zu den Parametern der Lipidkontrolle:
    • Reduzierung des LDL-C-Wertes um ≥50% gegenüber dem Ausgangswert und LDL-C < 1,4 mmol/L (<55 mg/dL) nach 6 und 22 Wochen,
    • Prozentuale Veränderung des LDL-C-Wertes vom Ausgangswert bis zu 6, 22 Wochen und 12 Monaten,
    • Zeit bis zum Erreichen des LDL-C-Zielwerts,
    • Durchschnittliche Veränderung des LDL-C-Wertes über 12 Monate,
    • Veränderung der anderen Lipidparameter (Gesamtcholesterin, HDL-C, Triglyceride, Non-HDL-C) nach 6, 22 Wochen und 12 Monaten gegenüber dem Ausgangswert.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The same rules as above for the primary evaluation criterion will be applied.
    Es werden die gleichen Regeln wie oben für das primäre Bewertungskriterium angewandt.
    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 No
    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
    les normes de soins uniquement, conformément aux lignes directrices de l'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 concerned7
    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
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Switzerland
    France
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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 state250
    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)
    none
    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 Decision2022-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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