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    Clinical Trial Results:
    STOP-AUST: The Spot sign and Tranexamic acid On Preventing ICH growth – AUStralasia Trial

    Summary
    EudraCT number
    		 2013-001262-42
    Trial protocol
    		 FI  
    Global end of trial date
    13 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2020
    First version publication date
    06 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NTA1201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01702636
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Florey Institute of Neuroscience and Mental Health
    Sponsor organisation address
    245 Burgundy Street, Heidelberg, Australia, VIC 3084
    Public contact
    Neuroscience Trials Australia, The Florey Institute of Neuroscience and Mental Health, 61 3-9035-7232,
    Scientific contact
    Neuroscience Trials Australia, The Florey Institute of Neuroscience and Mental Health, 61 3-9035-7232,
    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
    28 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test the hypothesis that ICH patients selected with CTA “spot sign” will have lower rates of haematoma growth when treated with intravenous tranexamic acid within 4.5 hours of stroke onset, compared to placebo.
    Protection of trial subjects
    Independent data monitoring committee, according to charter.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2012
    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
    Finland: 23
    Country: Number of subjects enrolled
    Australia: 65
    Country: Number of subjects enrolled
    Taiwan: 12
    Worldwide total number of subjects
    100
    EEA total number of subjects
    23
    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)
    100
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We recruited 100 participants between March 1, 2013, and Aug 13, 2019.

    Pre-assignment
    Screening details
    		 3325 patients with intracerebral patients seen at 7 hospitals during trial recruitment period (2.6 % of patients recruited into the trial).

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic acid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 gram tranexamic acid in 100 mL NaCl 0.9% infusion over 10 minutes followed by 1 gram tranexamic acid in 500 mL NaCl 0.9% infusion over 8 hours.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCl 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mL NaCl 0.9% in 100 mL NaCl 0.9% infusion over 10 minutes followed by 10 mL NaCl 0.9% in 500 mL NaCl 0.9% infusion over 8 hours.

    Number of subjects in period 1
    		Tranexamic acid Placebo
    Started
    50
    50
    Completed
    50
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tranexamic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Tranexamic acid Placebo Total
    Number of subjects
    		 50 50 100
    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
        median (inter-quartile range (Q1-Q3))
    		 73 (55 to 78) 71 (58 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 15 23 38
        Male
    		 35 27 62
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat full analysis set

    Subject analysis sets values
    		 ITT
    Number of subjects
    100
    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
        median (inter-quartile range (Q1-Q3))
    71 (57 to 79)
    Gender categorical
    Units: Subjects
        Female
    38
        Male
    62

    End points

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    End points reporting groups
    Reporting group title
    Tranexamic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat full analysis set

    Primary: intracerebral haemorrhage growth of at least 33% or 6 mL from baseline

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    End point title
    		 intracerebral haemorrhage growth of at least 33% or 6 mL from baseline
    End point description
    End point type
    Primary
    End point timeframe
    24 h (±3) after start of study drug
    End point values
    		 Tranexamic acid Placebo
    Number of subjects analysed
    50
    50
    Units: 2
    22
    26
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    Tranexamic acid v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1.59

    Secondary: absolute intracerebral haemorrhage growth volume

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    End point title
    		 absolute intracerebral haemorrhage growth volume
    End point description
    End point type
    Secondary
    End point timeframe
    24 h +/- 3h
    End point values
    		 Tranexamic acid Placebo ITT
    Number of subjects analysed
    49
    50
    99
    Units: mL
        median (inter-quartile range (Q1-Q3))
    1.9 (0.2 to 9.5)
    3.4 (0.0 to 16.0)
    2.7 (0.1 to 13.7)
    Statistical analysis title
    		 absolute ICH growth
    Comparison groups
    Tranexamic acid v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28
    Method
    		 median regression
    Parameter type
    		 Median difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 1.5

    Secondary: absolute intraventricular haemorrhage growth

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    End point title
    		 absolute intraventricular haemorrhage growth
    End point description
    End point type
    Secondary
    End point timeframe
    24 +/- 3 h
    End point values
    		 Tranexamic acid Placebo ITT
    Number of subjects analysed
    49
    50
    99 [1]
    Units: mL
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.6)
    0.0 (0.0 to 0.0)
    Notes
    [1] - Missing data for one tranexamic acid patient.
    Statistical analysis title
    		 absolute intraventricula haemorrhage growth
    Comparison groups
    Tranexamic acid v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.99
    Method
    		 median regression
    Parameter type
    		 Median difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Secondary: mRS 0–4 or return to prestroke score at 90 days

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    End point title
    		 mRS 0–4 or return to prestroke score at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Tranexamic acid Placebo ITT
    Number of subjects analysed
    50
    50
    100
    Units: mRS 0-4 or back to prestroke
    34
    40
    74
    Statistical analysis title
    		 mRS 0-4 or back to baseline
    Comparison groups
    Tranexamic acid v Placebo v ITT
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 1.23

    Secondary: mRS 0–3 or return to prestroke score at 90 days

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    End point title
    		 mRS 0–3 or return to prestroke score at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Tranexamic acid Placebo ITT
    Number of subjects analysed
    50
    50
    100
    Units: mRS 0-3 or back to prestroke
    28
    23
    51
    Statistical analysis title
    		 mRS 0-3 or back to baseline
    Comparison groups
    Placebo v Tranexamic acid v ITT
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 4.24

    Secondary: categorical shift in mRS at 90 days

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    End point title
    		 categorical shift in mRS at 90 days
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Tranexamic acid Placebo ITT
    Number of subjects analysed
    50
    50
    100
    Units: OR
        number (confidence interval 95%)
    1.01 (0.63 to 1.61)
    1.01 (0.63 to 1.61)
    1.01 (0.63 to 1.61)
    Statistical analysis title
    		 mRS categorical shift
    Comparison groups
    Tranexamic acid v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.97
    Method
    		 assumption-free Wilcoxon-Mann-Whitney ge
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.61
    Notes
    [2] - assumption-free Wilcoxon-Mann-Whitney generalised OR

    Secondary: major thromboembolic events

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    End point title
    		 major thromboembolic events
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Tranexamic acid Placebo ITT
    Number of subjects analysed
    50
    50
    100
    Units: Number of events
    1
    2
    3
    Statistical analysis title
    		 major thromboembolic events
    Comparison groups
    Tranexamic acid v Placebo v ITT
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.57
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 5.58

    Secondary: Death

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    End point title
    		 Death
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Tranexamic acid Placebo ITT
    Number of subjects analysed
    50
    50
    100
    Units: Deaths
        number (confidence interval 95%)
    13 (13 to 13)
    8 (8 to 8)
    2.38 (0.66 to 8.67)
    Statistical analysis title
    		 death within 90 days
    Comparison groups
    Tranexamic acid v Placebo v ITT
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 8.67

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    90 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Not reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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/33128912
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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
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