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    Clinical Trial Results:
    The effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)- a four arm randomised controlled trial

    Summary
    EudraCT number
    2013-001922-24
    Trial protocol
    GB  
    Global end of trial date
    03 Jun 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Nov 2020
    First version publication date
    12 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    120541
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01864252
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    ower St, Bloomsbury, London, United Kingdom, WC1E 6BT
    Public contact
    Prof. Derek M Yellon, The Hatter Cardiovascular Institute, 0044 000, d.yellon@ucl.ac.uk
    Scientific contact
    Prof. Derek M Yellon, The Hatter Cardiovascular Institute, 0044 000, d.yellon@ucl.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
    03 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. Does GTN administered as a continuous (intra-operative intravenous) infusion into a vein reduce injury to the heart muscle in patients undergoing heart-lung bypass Coronary Artery Bypass Graft (CABG) and/or valve surgery? 2. Does RIPC reduce injury to the heart muscle in the presence of GTN administered as a continuous (intra-operative intravenous) infusion into a vein in patients undergoing heart-lung bypass CABG and/or valve surgery?
    Protection of trial subjects
    N/A
    Background therapy
    GTN vs Placebo
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jul 2013
    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: 194
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    57
    From 65 to 84 years
    112
    85 years and over
    25

    Subject disposition

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    Recruitment
    Recruitment details
    Patient assessment prior to their elective admission

    Pre-assignment
    Screening details
    Patient were screened prior to their elective admission using the elective cardiac surgery lists.

    Period 1
    Period 1 title
    Full period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    RIP+Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    as per anesthetic team

    Arm title
    RIC+GTN
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    GTN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    As per anesthetic team

    Arm title
    Sham+GTN
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    as per anesthetic team

    Investigational medicinal product name
    GTN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    As per anesthetics

    Arm title
    Sham+Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    as per anesthetic team

    Number of subjects in period 1
    RIP+Placebo RIC+GTN Sham+GTN Sham+Placebo
    Started
    43
    49
    47
    45
    Completed
    43
    49
    47
    45
    Period 2
    Period 2 title
    baseline period
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst

    Arms
    Arm title
    Sham and GTN
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    GTN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    As per anesthetics

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: PERIOD 1 is the baseline period.
    Number of subjects in period 2 [2] [3]
    Sham and GTN
    Started
    47
    Completed
    47
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: these are consistent
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: This is due to drop outs and those who did not complete the trial.

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    RIP+Placebo
    Reporting group description
    -

    Reporting group title
    RIC+GTN
    Reporting group description
    -

    Reporting group title
    Sham+GTN
    Reporting group description
    -

    Reporting group title
    Sham+Placebo
    Reporting group description
    -
    Reporting group title
    Sham and GTN
    Reporting group description
    -

    Primary: Area under the curve for mean troponin

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    End point title
    Area under the curve for mean troponin [1]
    End point description
    End point type
    Primary
    End point timeframe
    01/2013 - 01/2019
    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: statistical analysis was undertaken
    End point values
    RIP+Placebo RIC+GTN Sham+GTN Sham+Placebo
    Number of subjects analysed
    43
    49
    47
    45
    Units: tropinin level
    geometric mean (geometric coefficient of variation)
        GTN-Sham
    28085 ± 0.8
    28085 ± 0.8
    28085 ± 0.8
    28085 ± 0.8
        GTN-RIPC
    31933 ± 1.8
    31933 ± 1.8
    31933 ± 1.8
    31933 ± 1.8
        Placebo-sham
    33775 ± 0
    33775 ± 0
    33775 ± 0
    33775 ± 0
        placebo-RIPC
    17945 ± 0.6
    17945 ± 0.6
    17945 ± 0.6
    17945 ± 0.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    03/2013 - 06/2019
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    Adverse event
    Reporting group description
    -

    Serious adverse events
    Adverse event
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Adverse event
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    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: Only SAEs occurred in the trial no non -serious adverse events

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2015
    Adding substudy
    20 Aug 2015
    Removing 72H tropinin level from trial

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Apr 2015
    Moving trial to Barts Trust
    09 Sep 2015

    Limitations and caveats

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