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    Clinical Trial Results:
    Simvastatin in aneurysmal subarchnoid haemorrhage (STASH): a multicentre randomised controlled clinical phase III study

    Summary
    EudraCT number
    		 2006-000277-30
    Trial protocol
    		 GB   SE  
    Global end of trial date
    10 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    30 Jul 2015
    Other versions
    Summary report(s)
    		 AEs & SAEs for STASH

    Trial information

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    Trial identification
    Sponsor protocol code
    STASH01
    Additional study identifiers
    ISRCTN number
    		 ISRCTN75948817
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cambridge University NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge University Hospitals NHS Foundation Trus, United Kingdom, CB2 0QQ
    Public contact
    Carole Turner, Dept of Neurosurgery , +44 1223 217205, clt29@medschl.cam.ac.uk
    Scientific contact
    Peter Kirkpatrick, Dept of Neurosurgery, +44 1223 217205, pjk21@medschl.cam.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
    10 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if up to a 3 week treatment period of simvastatin can improve the long-term outcome in subjects who have had an aneurysmal subarachnoid haemorrhage.
    Protection of trial subjects
    All subjects were monitored whilst in hospital as part of clinical care. Biochemical papameters were recorded at baseline and between days 9-12, in addition subjects were reviewed regularly by the research team.
    Background therapy
    		 Subjects received either simvastatin 40mg or a matched placebo, in tablet form, once a day for up to 14 days. The study medication stopped at discharge from the acute Neurosurgical Units.
    Evidence for comparator
    		 Matched placebo
    Actual start date of recruitment
    02 Jan 2007
    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
    Singapore: 25
    Country: Number of subjects enrolled
    Uruguay: 23
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Colombia: 10
    Country: Number of subjects enrolled
    Canada: 26
    Country: Number of subjects enrolled
    Russian Federation: 11
    Country: Number of subjects enrolled
    Sweden: 20
    Country: Number of subjects enrolled
    United Kingdom: 676
    Country: Number of subjects enrolled
    Italy: 6
    Worldwide total number of subjects
    803
    EEA total number of subjects
    702
    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)
    803
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period was Jan 2006 to Feb 2013. All patients were recruited in on an acute Neurosurgical ward in a tertiary referral centre

    Pre-assignment
    Screening details
    		 Patients were screened for eligiblitiy by the clinical team, on admission to the acute neurosurgical centre.

    Pre-assignment period milestones
    Number of subjects started
    		 803
    Number of subjects completed
    		 803

    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
    Blinding implementation details
    n/a

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Statin
    Arm description
    		 Subjects precribed to statin arm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Simvastatin
    Investigational medicinal product code
    C10A A01
    Other name
    Ritechol
    Pharmaceutical forms
    Tablet
    Routes of administration
    Nasogastric use , Oral use
    Dosage and administration details
    40mg once a day

    Arm title
    		 Placebo
    Arm description
    		 Subjects prescribed to placebo
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Statin Placebo
    Started
    391
    412
    Completed
    379
    403
    Not completed
    12
    9
         Lost to follow-up
    12
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Statin
    Reporting group description
    		 Subjects precribed to statin arm

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects prescribed to placebo

    Reporting group values
    		 Statin Placebo Total
    Number of subjects
    		 391 412 803
    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)
    		 391 412 803
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51 ± 9.5 49 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    		 260 291 551
        Male
    		 131 121 252
    UK subject
    Units: Subjects
        UK subject
    		 332 344 676
        non-UK subjects
    		 59 68 127

    End points

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    End points reporting groups
    Reporting group title
    Statin
    Reporting group description
    		 Subjects precribed to statin arm

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects prescribed to placebo

    Primary: Modified Rankin Scale (mRS)

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    End point title
    		 Modified Rankin Scale (mRS)
    End point description
    Clinical outcome as measured by the mRS
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Statin Placebo
    Number of subjects analysed
    379
    403
    Units: subjects
        mRS 0-2
    271
    289
        mRS 3-6
    108
    114
    Statistical analysis title
    		 analysis of outcome measures
    Statistical analysis description
    intention to treat population. Primary outcome based on ordinal analysis of 6 month mRS assuming treatment effect followed a proportional odds model
    Comparison groups
    Placebo v Statin
    Number of subjects included in analysis
    782
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.809
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.25
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    consent to discharge
    Adverse event reporting additional description
    Adverse events reported are given in the attachment. They are not coded .
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not coded
    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: The adverse events are given in the attachment AEs break down for the Statin Arm: # subjects exposed 391 # subjects affected by SAE 71 # subject affected by non-AE 63 # of deaths (all causes) 37 # of deaths resulting from AEs 37 AE break down for the Placebo Arm: # of subjects exposed 412 # of subjects affected by SAEs 74 # of subject affected by non-AEs 73 # of deaths (all causes) 35 # of deaths resulting from AEs 35

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2010
    Request to reduce the cohort from 1600 to 800 based on statistical analysis of the primary outcome measures

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Jun 2009
    Request by Sponsor to suspend recruitment as a result of a commissioned audit. It was noted that IMP was being supplied to sites in other contries with the label in English only. REC and MHRA were notified
    29 Jul 2010

    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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