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    Clinical Trial Results:
    Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage TICH-2

    Summary
    EudraCT number
    		 2012-004108-37
    Trial protocol
    		 GB   SE   ES   HU   DK   IT   IE  
    Global end of trial date
    28 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2018
    First version publication date
    18 Aug 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    12101
    Additional study identifiers
    ISRCTN number
    		 ISRCTN93732214
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CTA reference: 03057/056/001/00001, REC reference: 12/EM/0369
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Clinical Sciences Building, Nottingham City Campus, Hucknall Road, Nottingham, United Kingdom, NG5 1PB
    Public contact
    University of Nottingham Diane Havard Senior Trial Manager Division of Neurosciences (Stroke), University of Nottingham Diane Havard Senior Trial Manager Division of Neurosciences (Stroke), 00 44 (0)115 823 1775, diane.havard@nottingham.ac.uk
    Scientific contact
    University of Nottingham Nikola Sprigg Professor Stroke Medicine Division of Neurosciences (Stroke, University of Nottingham Nikola Sprigg Professor Stroke Medicine Division of Neurosciences (Stroke, 00 44 (0)115 823 1778, nikola.sprigg@nottingham.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 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH).
    Protection of trial subjects
    Patient lacks capacity to give consent: Lack of capacity waill be determined by the participant’s attending stroke physician. If the potential participant lacked capacity to give meaningful consent (e.g. in cases of dysphasia, confusion, or reduced conscious level) the following procedures were employed: Relatives available: If relatives were present, they were provided with brief information about the trial. Further information was provided on request. If relatives objected to the inclusion of the patient in the trial, their views were respected and the patient was not be enrolled. Full informed written consent was obtained from the patient or legal representative afterwards as soon as was practicable. If relatives were not physically present but available and happy to speak on the telephone, the same procedure was followed. If the relative was unhappy to speak on the telephone or unable to decide, the patient was not enrolled. Relatives not available: If no relatives were not available, a doctor was recruited, wherever possible unconnected with the trial, provide verbal information relating to the trial and obtain verbal consent for the patient's inclusion in the trial. If a doctor unconnected with the trial was not available patients were not enrolled into the trial. If enrolled, full informed written consent was obtained from the patient or their legal representative afterwards as soon as practicable. Serious adverse events: Serious adverse events are common in haemorrhagic stroke, for a full list of expected SAE that are not subject to expedited reporting, please refer to Appendix ???. As the IMP was administered once and has a short half life, serious adverse events occurring within the first 7 days were assessed for seriousness, expectedness and causality. In addition fatal SAEs and safety outcome events (VTE, recurrent stroke, TIA, MI, PAD and seizures) were reported until day 90.
    Background therapy
    		 Tranexamic acid is a licensed anti-fibrinolytic drug that can be administered intravenously or orally and is used in a number of bleeding conditions to reduce bleeding. In a recent mega-trial (CRASH-2) in 20,000 patients with major bleeding following trauma, tranexamic acid significantly reduced mortality, OR 0.91 (0.85-0.97), with no increase in vascular occlusive events. Treatment was most effective when given rapidly; delayed administration was associated with lack of efficacy and potential harm. In a subgroup analysis of patients with traumatic ICH, tranexamic acid showed a non-significant trend to reduced mortality, OR 0.47 (0.21-1.04), and death of dependency, OR 0.66 (0.32-1.36). However, patients in CRASH-2 were younger and had less co-morbidities than those with SICH. In another randomised controlled trial in traumatic intracerebral haemorrhage, tranexamic acid reduced death, OR 0.69 (0.35 -1.39), and death or dependency, 0.76 (0.46 – 1.27), without increased thromboembolic events. Tranexamic acid has been tested in aneurismal subarachnoid haemorrhage, where it reduced the risk of re-bleeding at the expense of increased risk of cerebral ischaemia. However administration was for a week, conferring prolonged exposure to risk of ischaemic events. Additionally, tranexamic acid has been found to restrict haematoma expansion in acute SICH in a small non randomised study, although this did not report on safety. In another small study (n=156), rapid administration of a bolus of tranexamic acid within 24 hours of stroke was observed to reduce haematoma expansion (17.5% vs. 4.3%). In this study, tranexamic acid was given in combination with intensive blood pressure control, suggesting that it may be possible to combine haemostatic and haemodynamic approaches. There have been recent calls in the literature for large clinical trials to examine the use of tranexamic acid in SICH.
    Evidence for comparator
    		 This was a placebo-controlled trial and the placebo in this instance was 0.9% normal saline administered by intravenous infusion.The placebo was supplied, packaged, labelled, QP released and distributed as for the active IMP (tranexamic acid).
    Actual start date of recruitment
    01 Mar 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    United Kingdom: 1910
    Country: Number of subjects enrolled
    Denmark: 39
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Ireland: 17
    Country: Number of subjects enrolled
    Italy: 96
    Country: Number of subjects enrolled
    Malaysia: 46
    Country: Number of subjects enrolled
    Georgia: 141
    Country: Number of subjects enrolled
    Switzerland: 46
    Country: Number of subjects enrolled
    Turkey: 9
    Worldwide total number of subjects
    2325
    EEA total number of subjects
    2083
    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)
    837
    From 65 to 84 years
    1198
    85 years and over
    290

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The trial setting was in secondary care, in acute stroke services across the UK and worldwide; 2325 patients recruited from 124 centres (94 UK, 30 non-UK) in 12 countries.Participants will be recruited from the acute stroke unit or emergency admissions department. The initial approach will be from a member of the patient’s usual care team.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Adult (≥18 years) patients with acute SICH within 8 hours of stroke onset. (Where stroke onset time is unknown, the time of when last known well was used.

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Central randomisation using a secure internet site in real-time involved minimisation on key prognostic factors: age; sex; time since onset; systolic blood pressure; stroke severity (NIHSS); presence of intraventricular haemorrhage; & known history antiplatelet treatment used immediately prior to stroke onset - ensuring concealment of allocation, minimising differences in key baseline prognostic variables, and slightly improving statistical power

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 tranexamic acid
    Arm description
    		 active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Cyklokapron, 100mg/ml 5ml ampoules, Pfizer Manufacturing Authorisation: PL 00057/0952)
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as tranexamic acid 1g (10ml in 100ml sodium chloride 0.9% infusion bag) through a venous cannula with a loading dose infusion over 10 minutes followed by 1g infusion (10ml in 250ml sodium chloride 0.9% infusion bag) over 8 hours. Placebo treatment replaced tranexamic acid 100mg/ml with sodium chloride 0.9%

    Arm title
    		 Placebo controlled
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    N/A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as a 100ml sodium chloride 0.9% infusion bag through a venous cannula over 10 minutes followed by a 250ml sodium chloride 0.9% infusion bag over 8 hours.

    Number of subjects in period 1
    		tranexamic acid Placebo controlled
    Started
    1161
    1164
    Completed
    1161
    1164
    Period 2
    Period 2 title
    Day 2 follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Central randomisation using a secure internet site in real-time. Randomisation involved minimisation on key prognostic factors: age; sex; time since onset; systolic blood pressure; stroke severity (NIHSS); presence of intraventricular haemorrhage; known history antiplatelet treatment used immediately prior to stroke onset. This approach ensured concealment of allocation, minimised differences in key baseline prognostic variables, and slightly improved statistical power.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic Acid
    Arm description
    		 Experimental drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Cyklokapron, 100mg/ml 5ml ampoules, Pfizer Manufacturing Authorisation: PL 00057/0952)
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as tranexamic acid 1g (10ml in 100ml sodium chloride 0.9% infusion bag) through a venous cannula with a loading dose infusion over 10 minutes followed by 1g infusion (10ml in 250ml sodium chloride 0.9% infusion bag) over 8 hours. Placebo treatment replaced tranexamic acid 100mg/ml with sodium chloride 0.9%

    Arm title
    		 Placebo
    Arm description
    		 Control
    Arm type
    		 Placebo

    Investigational medicinal product name
    sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    N/A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as a 100ml sodium chloride 0.9% infusion bag through a venous cannula over 10 minutes followed by a 250ml sodium chloride 0.9% infusion bag over 8 hours.

    Number of subjects in period 2
    		Tranexamic Acid Placebo
    Started
    1161
    1164
    Completed
    1121
    1107
    Not completed
    40
    57
         Adverse event, serious fatal
    40
    57
    Period 3
    Period 3 title
    Day 7 follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Central randomisation using a secure internet site in real-time. Randomisation involved minimisation on key prognostic factors: age; sex; time since onset; systolic blood pressure; stroke severity (NIHSS); presence of intraventricular haemorrhage; known history antiplatelet treatment used immediately prior to stroke onset. This approach ensured concealment of allocation, minimised differences in key baseline prognostic variables, and slightly improved statistical power.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic Acid
    Arm description
    		 Experimental drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Cyklokapron, 100mg/ml 5ml ampoules, Pfizer Manufacturing Authorisation: PL 00057/0952)
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as tranexamic acid 1g (10ml in 100ml sodium chloride 0.9% infusion bag) through a venous cannula with a loading dose infusion over 10 minutes followed by 1g infusion (10ml in 250ml sodium chloride 0.9% infusion bag) over 8 hours. Placebo treatment replaced tranexamic acid 100mg/ml with sodium chloride 0.9%

    Arm title
    		 Placebo
    Arm description
    		 Control
    Arm type
    		 Placebo

    Investigational medicinal product name
    sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    N/A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as a 100ml sodium chloride 0.9% infusion bag through a venous cannula over 10 minutes followed by a 250ml sodium chloride 0.9% infusion bag over 8 hours.

    Number of subjects in period 3
    		Tranexamic Acid Placebo
    Started
    1121
    1107
    Completed
    1060
    1041
    Not completed
    61
    66
         Adverse event, serious fatal
    61
    66
    Period 4
    Period 4 title
    Day 90 follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Central randomisation using a secure internet site in real-time. Randomisation involved minimisation on key prognostic factors: age; sex; time since onset; systolic blood pressure; stroke severity (NIHSS); presence of intraventricular haemorrhage; known history antiplatelet treatment used immediately prior to stroke onset. This approach ensured concealment of allocation, minimised differences in key baseline prognostic variables, and slightly improved statistical power.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tranexamic Acid
    Arm description
    		 Experimental drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Cyklokapron, 100mg/ml 5ml ampoules, Pfizer Manufacturing Authorisation: PL 00057/0952)
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as tranexamic acid 1g (10ml in 100ml sodium chloride 0.9% infusion bag) through a venous cannula with a loading dose infusion over 10 minutes followed by 1g infusion (10ml in 250ml sodium chloride 0.9% infusion bag) over 8 hours. Placebo treatment replaced tranexamic acid 100mg/ml with sodium chloride 0.9%

    Arm title
    		 Placebo
    Arm description
    		 Control
    Arm type
    		 Placebo

    Investigational medicinal product name
    tranexamic acid
    Investigational medicinal product code
    Other name
    Cyklokapron, 100mg/ml 5ml ampoules, Pfizer Manufacturing Authorisation: PL 00057/0952)
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as tranexamic acid 1g (10ml in 100ml sodium chloride 0.9% infusion bag) through a venous cannula with a loading dose infusion over 10 minutes followed by 1g infusion (10ml in 250ml sodium chloride 0.9% infusion bag) over 8 hours. Placebo treatment replaced tranexamic acid 100mg/ml with sodium chloride 0.9%

    Investigational medicinal product name
    sodium chloride 0.9%
    Investigational medicinal product code
    Other name
    N/A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trial treatment was administered as a 100ml sodium chloride 0.9% infusion bag through a venous cannula over 10 minutes followed by a 250ml sodium chloride 0.9% infusion bag over 8 hours.

    Number of subjects in period 4
    		Tranexamic Acid Placebo
    Started
    1060
    1041
    Completed
    1152
    1155
    Not completed
    158
    135
         Adverse event, serious fatal
    149
    126
         Consent withdrawn by subject
    6
    3
         Lost to follow-up
    3
    6
    Joined
    250
    249
         Death scores included
    250
    249

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    tranexamic acid
    Reporting group description
    		 active treatment

    Reporting group title
    Placebo controlled
    Reporting group description
    		 -

    Reporting group values
    		 tranexamic acid Placebo controlled Total
    Number of subjects
    		 1161 1164 2325
    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)
    		 406 431 837
        From 65-84 years
    		 612 586 1198
        85 years and over
    		 143 147 290
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.1 ( 13.7 ) 68.7 ( 13.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 519 505 1024
        Male
    		 642 659 1301

    End points

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    End points reporting groups
    Reporting group title
    tranexamic acid
    Reporting group description
    		 active treatment

    Reporting group title
    Placebo controlled
    Reporting group description
    		 -
    Reporting group title
    Tranexamic Acid
    Reporting group description
    		 Experimental drug

    Reporting group title
    Placebo
    Reporting group description
    		 Control
    Reporting group title
    Tranexamic Acid
    Reporting group description
    		 Experimental drug

    Reporting group title
    Placebo
    Reporting group description
    		 Control
    Reporting group title
    Tranexamic Acid
    Reporting group description
    		 Experimental drug

    Reporting group title
    Placebo
    Reporting group description
    		 Control

    Primary: Death or dependency (modified Rankin Scale, mRS) at day 90.

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    End point title
    		 Death or dependency (modified Rankin Scale, mRS) at day 90.
    End point description
    Death or dependency (modified Rankin Scale, mRS) at day 90.
    End point type
    Primary
    End point timeframe
    from randomisation to day 90
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    1152
    1155
    Units: Numbers
        MRS 0
    26
    24
        MRS 1
    115
    124
        MRS 2
    197
    181
        MRS 3
    187
    194
        MRS 4
    213
    221
        MRS 5
    164
    162
        MRS 6
    250
    249
    Statistical analysis title
    		 Odds ratio
    Comparison groups
    Tranexamic Acid v Placebo
    Number of subjects included in analysis
    2307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11
    Method
    		 Ordinal logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.03

    Secondary: Disability (Barthel index) at day 90

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    End point title
    		 Disability (Barthel index) at day 90
    End point description
    Disability (Barthel index) at day 90
    End point type
    Secondary
    End point timeframe
    from randomisation to day 90
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    1152
    1155
    Units: Mean
        arithmetic mean (standard deviation)
    52.92 ( 44.0 )
    53.21 ( 43.7 )
    No statistical analyses for this end point

    Secondary: Quality of Life (EuroQol) at day 90

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    End point title
    		 Quality of Life (EuroQol) at day 90
    End point description
    Quality of Life (EuroQol) at day 90
    End point type
    Secondary
    End point timeframe
    from randomisation to day 90
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    1152
    1155
    Units: Mean
        arithmetic mean (standard deviation)
    0.34 ( 0.4 )
    0.34 ( 0.4 )
    No statistical analyses for this end point

    Secondary: Cognition

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    End point title
    		 Cognition
    End point description
    Cognition and mood at day 90 (TICS and ZDS).
    End point type
    Secondary
    End point timeframe
    from randomisation to day 90
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    1152
    1155
    Units: Mean
        arithmetic mean (standard deviation)
    13.57 ( 12.5 )
    13.94 ( 12.8 )
    No statistical analyses for this end point

    Secondary: Seizures

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    End point title
    		 Seizures
    End point description
    Seizures
    End point type
    Secondary
    End point timeframe
    from randomisation to end of study
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    1152
    1155
    Units: Numbers
    77
    85
    No statistical analyses for this end point

    Secondary: Mood

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    End point title
    		 Mood
    End point description
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    1152
    1155
    Units: Mean
        arithmetic mean (standard deviation)
    67.28 ( 29.5 )
    67.29 ( 29.9 )
    No statistical analyses for this end point

    Other pre-specified: Death

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    End point title
    		 Death
    End point description
    cause of death
    End point type
    Other pre-specified
    End point timeframe
    from randomisation to end of study
    End point values
    		 Tranexamic Acid Placebo
    Number of subjects analysed
    1152
    1155
    Units: Numbers
    250
    249
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 90
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    tranexamic acid
    Reporting group description
    		 active treatment

    Reporting group title
    Placebo controlled
    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: Only serious adverse events were collected for the trial
    Serious adverse events
    		 tranexamic acid Placebo controlled
    Total subjects affected by serious adverse events
         subjects affected / exposed
    521 / 1161 (44.88%)
    556 / 1164 (47.77%)
         number of deaths (all causes)
    250
    249
         number of deaths resulting from adverse events
    250
    249
    General disorders and administration site conditions
    All SAE's
         subjects affected / exposed
    521 / 1161 (44.88%)
    556 / 1164 (47.77%)
         occurrences causally related to treatment / all
    0 / 742
    5 / 781
         deaths causally related to treatment / all
    0 / 250
    3 / 249
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 tranexamic acid Placebo controlled
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1161 (0.00%)
    0 / 1164 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Dec 2012
    The protocol had to be amended following REC review. The changes relate to participant identifiers and the consent process for potential participants who are not able to consent for themselves and do not have relatives present.
    09 Oct 2013
    Update to Part B Section 3 (Radiation) on the REC and R&D Form.
    28 Feb 2014
    Extension to follow up period, temperature monitoring, co-enrolment. clarification of consent procedures in the emergency situation, typographical errors.
    04 Mar 2015
    addition of MRI sub study.
    24 Jul 2015
    Update to MRI sub study consent forms – to include missing initial box and remove participant signature line on personal legal representative consent form as participant would not sign this form.
    09 Nov 2015
    Minor amendment to MRI sub study consent forms.
    26 May 2016
    Addition of plasma biomarkers sub study in one centre.
    01 Sep 2017
    1 September 2016 - 12 month extension. Recruitment ended September 2017, grant closure February 2018.

    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/29778325
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