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    Clinical Trial Results:
    MINeralocorticoid receptor antagonist pretreatment to MINIMISE reperfusion injury after ST-Elevation Myocardial Infarction(STEMI).

    Summary
    EudraCT number
    		 2013-001069-18
    Trial protocol
    		 GB  
    Global end of trial date
    04 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2017
    First version publication date
    24 Aug 2017
    Other versions
    Summary report(s)
    		 Trial design paper

    Trial information

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    Trial identification
    Sponsor protocol code
    12/0533
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EudraCT number: 2013-001069-18
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    149 Tottenham Court Road, London, United Kingdom, London W1T 7DN
    Public contact
    Derek Hausenloy, Hatter Cardiovascular Institute, +44 203 447 9894, d.hausenloy@ucl.ac.uk
    Scientific contact
    Derek Hausenloy, Hatter Cardiovascular Institute, +44 203 447 9894, d.hausenloy@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
    06 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Does the administration of mineralo-corticoid-receptor antagonist (MRA) therapy initiated prior to coronary angioplasty followed by three months MRA therapy reduced the damage to the heart muscle in patients presenting with a heart attack?
    Protection of trial subjects
    No applicable
    Background therapy
    		 -
    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: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    42
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 111 patients gave initial consent and 70 patients were enrolled in the study.

    Pre-assignment
    Screening details
    		 951 patients were screened between November 2013 and January 2016

    Period 1
    Period 1 title
    Nov 2013 to Jan 2016 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst
    Blinding implementation details
    Eligible patients were randomised by the unblinded study investigator to Aldactone® canrenoate treatment or placebo immediately after the diagnostic coronary angiography. Randomisation was done on a web-based service through www.SealedEnvelope.com. The study team member collecting the data at each study site remained blinded to the allocation of patients to either intervention or placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention arm
    Arm description
    		 one single bolus i.v. Aldactone® canrenoate 200 mg prior to reopening of the infarcted artery followed by 25 mg spironolactone oral, daily for 3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aldactone canrenoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Aldactone® canrenoate 200 mg prior to reopening of the infarcted artery followed by 3 months of oral spironolactone 25 mg

    Arm title
    		 Placebo
    Arm description
    		 10 ml normal saline drawn-up into an identical opaque syringe given as a bolus over 2 minutes.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    The placebo was 10 ml normal saline drawn-up into an identical opaquesyringe given as a bolus over 2 minutes, prior to PPCI

    Number of subjects in period 1
    		Intervention arm Placebo
    Started
    38
    32
    Interim analysis
    38
    32
    Completed
    38
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nov 2013 to Jan 2016
    Reporting group description
    		 -

    Reporting group values
    		 Nov 2013 to Jan 2016 Total
    Number of subjects
    		 70 70
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 42 42
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 62 (53 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 60 60

    End points

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    End points reporting groups
    Reporting group title
    Intervention arm
    Reporting group description
    		 one single bolus i.v. Aldactone® canrenoate 200 mg prior to reopening of the infarcted artery followed by 25 mg spironolactone oral, daily for 3 months.

    Reporting group title
    Placebo
    Reporting group description
    		 10 ml normal saline drawn-up into an identical opaque syringe given as a bolus over 2 minutes.

    Primary: Chronic infarct size by CMR

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    End point title
    		 Chronic infarct size by CMR
    End point description
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    		 Intervention arm Placebo
    Number of subjects analysed
    38
    32
    Units: percentage
        arithmetic mean (standard deviation)
    16 ( 10 )
    17 ( 11 )
    Statistical analysis title
    		 Primary outcome analysis
    Statistical analysis description
    The primary endpoint (myocardial infarct (MI) size in grams at 12 weeks) was compared between those randomised to placebo and those randomised to mineralocorticoid receptor antagonist therapy (MRA) using linear regression with the myocardial infarct size at three months as the response variable and the treatment group included as a binary covariate in the model. The distribution of MI size in grams showed marked positive skew, but this distribution was normalised by expressing MI size as % of LV
    Comparison groups
    Placebo v Intervention arm
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Acute MI size by CMR

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    End point title
    		 Acute MI size by CMR
    End point description
    End point type
    Secondary
    End point timeframe
    Within the first week.
    End point values
    		 Intervention arm Placebo
    Number of subjects analysed
    38
    32
    Units: percentage
        arithmetic mean (standard deviation)
    23 ( 14 )
    26 ( 16 )
    No statistical analyses for this end point

    Secondary: Microvascular obstruction

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    End point title
    		 Microvascular obstruction
    End point description
    End point type
    Secondary
    End point timeframe
    One week
    End point values
    		 Intervention arm Placebo
    Number of subjects analysed
    38
    32
    Units: percentage
    65
    67
    No statistical analyses for this end point

    Secondary: Change in end-diastolic volume at 3 months

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    End point title
    		 Change in end-diastolic volume at 3 months
    End point description
    Change in LV end-diastolic at 3 months
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Intervention arm Placebo
    Number of subjects analysed
    38
    32
    Units: percentage
        arithmetic mean (standard deviation)
    -3 ( 16 )
    10 ( 14 )
    No statistical analyses for this end point

    Secondary: Change in end-systolic volume at 3 months

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    End point title
    		 Change in end-systolic volume at 3 months
    End point description
    Cchange in end-systolic volume at 3 months
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Intervention arm Placebo
    Number of subjects analysed
    38
    32
    Units: percentage
        arithmetic mean (standard deviation)
    -12 ( 24 )
    6 ( 24 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    November 2015 to April 2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Intervention
    Reporting group description
    		 -

    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: Less than 5% of non-serious adverse events recorded.
    Serious adverse events
    		 Placebo Intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 32 (28.13%)
    11 / 38 (28.95%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    3 / 32 (9.38%)
    5 / 38 (13.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arrhythmia
         subjects affected / exposed
    4 / 32 (12.50%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Panic attack
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 38 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 38 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2016
    Change in trial statistician which led to a change in statistical plan.

    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
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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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