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    Clinical Trial Results:
    Effects of the PCSK9 Antibody AliroCuMab on Coronary Atherosclerosis in PatieNts with Acute Myocardial Infarction. A Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging Study

    Summary
    EudraCT number
    		 2017-001502-15
    Trial protocol
    		 DK   AT  
    Global end of trial date
    13 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2022
    First version publication date
    11 Oct 2022
    Other versions
    Summary report(s)
    		 PACMAN-JAMA
    PACMAN-JAMA-SupplMaterial
    PACMAN-AHJ-Design
    PACMAN-Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    PACMAN-AMI/ 2016-01382
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03067844
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Insel-Nr.: 3277
    Sponsors
    Sponsor organisation name
    EU Sponsor representative AKH Vienna, Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel, Vienna, Austria, 1090
    Public contact
    Prof. Dr. Irene Lang, AKH Vienna, Medical University of Vienna, 43 14040046140, irene.lang@meduniwien.ac.at
    Scientific contact
    Prof. Dr. Irene Lang, AKH Vienna, Medical University of Vienna, 43 14040046140, irene.lang@meduniwien.ac.at
    Sponsor organisation name
    Insel Gruppe AG
    Sponsor organisation address
    Freiburgstrasse , Bern, Switzerland, 3010
    Public contact
    Prof. Dr. med. Lorenz Räber, Insel Gruppe AG, kardio.studien@insel.ch
    Scientific contact
    Prof. Dr. med. Lorenz Räber, Insel Gruppe AG, kardio.studien@insel.ch
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of the PCSK9 inhibitor alirocumab on the change in percent atheroma volume (PAV) at week 52 in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI) in the infarct-related artery and receiving uidelinerecommended high-intensity statin therapy.
    Protection of trial subjects
    Regular followup, Data Safety Monitoring Board (trial with approved drug / placebo but outside indication)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    Austria: 38
    Country: Number of subjects enrolled
    Denmark: 34
    Country: Number of subjects enrolled
    Switzerland: 212
    Worldwide total number of subjects
    300
    EEA total number of subjects
    88
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    217
    From 65 to 84 years
    83
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 01May2017 to 01Oct2020 CH, NL, DK, AU For further details see main manuscript: Räber L et al., JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218. PMID: 35368058; PMCID: PMC8978048.

    Pre-assignment
    Screening details
    		 See main manuscript

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Active treatment: prefilled pen; sterile alirocumab drug product supplied at a concentration of 150 mg/mL in histidine, pH 6.0, polysorbate 20, and sucrose. Placebo: matched for content to verum except alirocumab Patients and treating physicians should refrain from LDL-C measurements throughout the whole study time to maintain blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Arm
    Arm description
    		 alirocumab arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alirocumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Solution for injection
    Dosage and administration details
    Biweekly subcutaneous alirocumab (150 mg) for 52 weeks

    Arm title
    		 Placebo Arm
    Arm description
    		 Placebo Arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Injection
    Dosage and administration details
    Biweekly injection for 52 weeks

    Number of subjects in period 1
    		Treatment Arm Placebo Arm
    Started
    148
    152
    Completed
    131
    135
    Not completed
    17
    17
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    13
    15
         Physician decision
    1
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 300 300
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.5 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 56 56
        Male
    		 244 244
    Subject analysis sets

    Subject analysis set title
    Experimental Intervention Group
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to the expermimental group to receive biweekly subcutaneous alirocumab (150 mg) beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg.

    Subject analysis set title
    Control Group
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to the placebo group to receive biweekly subcutaneous placebo beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg.

    Subject analysis sets values
    		 Experimental Intervention Group Control Group
    Number of subjects
    148
    152
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.4 ± 10
    58.6 ± 9.4
    Gender categorical
    Units: Subjects
        Female
    24
    32
        Male
    124
    119

    End points

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    End points reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 alirocumab arm

    Reporting group title
    Placebo Arm
    Reporting group description
    		 Placebo Arm

    Subject analysis set title
    Experimental Intervention Group
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to the expermimental group to receive biweekly subcutaneous alirocumab (150 mg) beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg.

    Subject analysis set title
    Control Group
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to the placebo group to receive biweekly subcutaneous placebo beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg.

    Primary: Change in PAV via IVUS from baseline to week 52

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    End point title
    		 Change in PAV via IVUS from baseline to week 52 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Stasticial Analsys for primary endpoint is specified in attached publications (main publication wit suppl. material and design publication)
    End point values
    		 Treatment Arm Placebo Arm
    Number of subjects analysed
    130
    135
    Units: %
        arithmetic mean (full range (min-max))
    -2.13 (-2.53 to -1.73)
    -0.92 (-1.28 to -0.56)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Events as defined per protocol needed to be reported from ICF signature until last follow-up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See attached publications for Adverse Events (main publication wit suppl. material)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Aug 2019
    Increase of patient number
    21 Jan 2020
    Improved wording (re-formulation) of one exlusion criteria
    27 Mar 2020
    COVID-19 Addendum: The changes are listed in this separate protocol addendum as these changes only apply to the patient and study management affected by the SARS-CoV-2 pandemia. If possible, patient management and study conduct according the approved study protocol, should be prioritized, if in line with current local laws and regulations. - Prolongation 52-week visit window if required by local hospital guidelines and situation - Interruption (on hold) of enrolment for the time necessary according to local hospital and national guidelines in view of the pandemic development - Changes to Visit schedule if required by local hospital guidelines and situation

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35368058
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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