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    Clinical Trial Results:
    Elafin Myocardial Protection from Ischaemia RepErfusion injury: A randomised trial to investigate the effect of Elafin on myocardial injury and inflammation in coronary bypass surgery (EMPIRE)

    Summary
    EudraCT number
    		 2010-019527-58
    Trial protocol
    		 GB  
    Global end of trial date
    16 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Aug 2020
    First version publication date
    01 Aug 2020
    Other versions
    Summary report(s)
    		 Perioperative elafin for ischaemia-reperfusion injury during coronary artery bypass graft surgery: a randomised-controlled trial

    Trial information

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    Trial identification
    Sponsor protocol code
    2010-019527-58
    Additional study identifiers
    ISRCTN number
    		 ISRCTN82061264
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ACCORD (University of Edinburgh & NHS Lothian)
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Kat Oatey, University of Edinburgh, +44 0131 537 3841, k.oatey@ed.ac.uk
    Scientific contact
    Dr Peter Henriksen, University of Edinburgh, +44 0131 537 3834, phenrik1@staffmail.ed.ac.uk
    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
    14 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that perioperative Elafin administration reduces post-ischaemic inflammatory myocardial injury following coronary artery bypass graft surgery.
    Protection of trial subjects
    This single center clinical trial was performed with the approval of the national research ethics committee (11/MRE00/5), in accordance with the Declaration of Helsinki (2000), under a Clinical Trial Authorization (27586/0015/001-0001) from the Medicine and Healthcare products Regulatory Authority (MHRA, United Kingdom), and the written informed consent of all participants.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Aug 2011
    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
    United Kingdom: 87
    Worldwide total number of subjects
    87
    EEA total number of subjects
    87
    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)
    47
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between June 2011 and September 2013, consecutive patients referred for elective CABG surgery were recruited from two clinics at Edinburgh Heart Centre. Patients were 18 years or older, and were referred for isolated CABG surgery requiring 2 or more grafts. Exclusion criteria included patients with recent myocardial infarction (within 1 month of su

    Pre-assignment
    Screening details
    		 A total of 189 patients were screened for recruitment of whom 29 were excluded, 79 declined to participate, 88 patients gave informed consent and 1 died before surgery leaving 87 patients to undergo randomisation.

    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, Assessor
    Blinding implementation details
    Treatment was blinded to both the research team and the subject. To ensure blinding, study drugs were prepared by staff independent of the study investigators or clinical team responsible for the patients care.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Elafin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elafin
    Investigational medicinal product code
    CAS number: 820211-82-3.
    Other name
    N/A
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous recombinant human Elafin (Proteo Biotech AG, Germany) 200 mg was prepared and infused as aqueous solution of 250 mL 0.9% saline.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% saline
    Investigational medicinal product code
    Other name
    N/A
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Saline placebo was prepared and infused as aqueous solution of 250 mL 0.9% saline.

    Number of subjects in period 1
    		Active Placebo
    Started
    44
    43
    Received inufsion
    43
    42
    Completed
    43
    42
    Not completed
    1
    1
         Infusion not given - not informed of surgery time
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Elafin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 44 43 87
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 24 23 47
        From 65-84 years
    		 20 20 40
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.9 ( 7.7 ) 63.6 ( 8.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 7 13
        Male
    		 38 36 74
    Baseline Data - characteristics used in minimisation algorithm (Diabetes mellitus)
    Characteristics used in minimisation algorithm
    Units: Subjects
        Diabetes mellitus present
    		 11 9 20
        Diabetes mellitus absent
    		 33 34 67
    Baseline data - characteristics used in minimisation algorithm (extent of coronary artery disease)
    Characteristics used in minimisation algorithm
    Units: Subjects
        2 vessel
    		 11 12 23
        3 vessel
    		 33 31 64
    Baseline data - characteristics used in minimisation algorithm (eGFR (mL/min))
    Characteristics used in minimisation algorithm
    Units: Subjects
        40 to 60
    		 5 4 9
        60+
    		 39 39 78
    Baseline data - characteristics used in minimisation algorithm (surgeon)
    Characteristics used in minimisation algorithm
    Units: Subjects
        Surgeon A
    		 18 16 34
        Surgeon B
    		 26 27 53

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Elafin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: The primary endpoint is the log area under the curve for plasma troponin I concentration profile over the first 48 h

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    End point title
    		 The primary endpoint is the log area under the curve for plasma troponin I concentration profile over the first 48 h
    End point description
    End point type
    Primary
    End point timeframe
    48 hours
    End point values
    		 Active Placebo
    Number of subjects analysed
    42 [1]
    41 [2]
    Units: unitless
        arithmetic mean (standard deviation)
    4.44 ( 1 )
    4.77 ( 1.1 )
    Notes
    [1] - 2 patients AUC could not be calculated - no Troponin I blood result/ highly-sensitive Troponin value
    [2] - 2 patients AUC could not be calculated - no Troponin I blood result/ highly-sensitive Troponin value
    Statistical analysis title
    		 48 hour plasma troponin I concentration profile
    Statistical analysis description
    Log area under the curve for plasma troponin I concentration profile over the first 48 h. General linear model.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.181 [3]
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 0.14
    Notes
    [3] - P=0.05

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) that occur after joining the trial must be reported in detail in the CRF. In the case of an AE, the Investigator should initiate the appropriate treatment according to their medical judgement. Participants with AEs present at the
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Elafin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    No treatment received
    Reporting group description
    		 Participants were consented but had received no treatment at the time of adverse event

    Serious adverse events
    		 Active Placebo No treatment received
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 43 (9.30%)
    5 / 42 (11.90%)
    2 / 3 (66.67%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Surgical and medical procedures
    Surgery
         subjects affected / exposed
    4 / 43 (9.30%)
    5 / 42 (11.90%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active Placebo No treatment received
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 43 (60.47%)
    18 / 42 (42.86%)
    0 / 3 (0.00%)
    Surgical and medical procedures
    Surgery
         subjects affected / exposed
    26 / 43 (60.47%)
    18 / 42 (42.86%)
    0 / 3 (0.00%)
         occurrences all number
    26
    18
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2011
    Removing women of child bearing potential. Protocol v3
    16 Jun 2011
    Detailing the delay in supply of feraheme but adding text to protocol and PIS to allow start of recruitment without this aspect of study. Protocol v5
    21 Mar 2012
    Extension of shelf life. Protocol v7
    05 Sep 2012
    Addition of 10 healthy volunteers. Protocol v8
    10 Apr 2013
    Extension request and addition of 36 additional participants without MRI scans. Protocol v9

    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.
    N/A

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26310261
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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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