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    Clinical Trial Results:
    A study of very low dose twice-daily compared to standard low dose once-daily aspirin following acute coronary syndromes - WILL lOWer dose aspirin be more effective following ACS?

    Summary
    EudraCT number
    		 2016-000920-25
    Trial protocol
    		 GB  
    Global end of trial date
    30 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2018
    First version publication date
    07 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    STH19177
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02741817
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS FT
    Sponsor organisation address
    Glossop ROad, Sheffield, United Kingdom, S10 2JF
    Public contact
    Clinical Research Office, Sheffield Teaching Hospitals NHS Foundation Trust, 0114 2712763, ResearchAdministration@sth.nhs.uk
    Scientific contact
    Prof Rob Storey, Sheffield Teaching Hospitals NHS Foundation Trust, r.f.storey@sheffield.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
    30 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal objective of this study is to assess the effects of two aspirin regimens (very low dose twice daily or standard low dose once daily) on the levels of thromboxane and prostacyclin, substances relevant to platelet activity, measured as their breakdown products in blood and urine, in patients on dual antiplatelet therapy for acute coronary syndromes (heart attacks and severe 'unstable' angina).
    Protection of trial subjects
    Study participants were asked to take a lower dose of aspirin than usual for 14 days within the study. The patients to be studied were already on established on standard doses of aspirin and ticagrelor for acute coronary syndromes (ACS), and enough into the treatment period to be in a stable phase and therefore to minimise any additional risk. The REC approved protocol was followed as well as local SOPs. The IMP dose and bleeding times were kept to the mininum to answer the outcome measure.
    Background therapy
    		 Not applicable as there was no requirements for the patient to be on any other drugs.
    Evidence for comparator
    		 Aspirin 75mg once daily represents guideline directed standard therapy.
    Actual start date of recruitment
    28 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    10
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 20/06/2016 to 01/12/2016. Participants were recruited from England at one site in Sheffield.

    Pre-assignment
    Screening details
    		 Number of subjects screened: 216 Screening enrollment criteria Male or female aged over 18 years Diagnosis of acute coronary syndrome greater than 30 days and less than 10 months Receiving dual antiplatelet therapy with aspirin 75 mg once daily and ticagrelor 90 mg twice daily

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    Study medication period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1
    Arm description
    		 Aspirin 20mg twice daily for 14 days and Ticagrelor 90mg twice daily for 14 days Followed by Aspirin 75mg once daily for 14 days and Ticagrelor 90mg twice daily for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aspirine lysine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg twice daily or 75mg twice daily

    Arm title
    		 Sequence 2
    Arm description
    		 Aspirin 75mg twice daily for 14 days and Ticagrelor 90mg twice daily for 14 days Followed by Aspirin 20mg once daily for 14 days and Ticagrelor 90mg twice daily for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aspirine lysine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg twice daily or 75mg twice daily

    Number of subjects in period 1
    		Sequence 1 Sequence 2
    Started
    10
    10
    Visit 1 -14 days
    10
    10
    Visit 2 - 28 days
    10
    10
    Visit 3 - 42 days
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study medication period
    Reporting group description
    		 -

    Reporting group values
    		 Study medication period Total
    Number of subjects
    		 20 20
    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
        arithmetic mean (standard deviation)
    		 64.3 ± 11.9 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Pharmacodynamic analysis set Aspririn 20mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised to receive study medication when receiving Aspirin 20mg

    Subject analysis set title
    Pharmacodynamic analysis set Aspirin 75mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients that received Aspirin 75mg

    Subject analysis sets values
    		 Pharmacodynamic analysis set Aspririn 20mg Pharmacodynamic analysis set Aspirin 75mg
    Number of subjects
    20
    20
    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
        arithmetic mean (standard deviation)
    64.3 ± 11.9
    64.3 ± 11.9
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    16

    End points

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    End points reporting groups
    Reporting group title
    Sequence 1
    Reporting group description
    		 Aspirin 20mg twice daily for 14 days and Ticagrelor 90mg twice daily for 14 days Followed by Aspirin 75mg once daily for 14 days and Ticagrelor 90mg twice daily for 14 days

    Reporting group title
    Sequence 2
    Reporting group description
    		 Aspirin 75mg twice daily for 14 days and Ticagrelor 90mg twice daily for 14 days Followed by Aspirin 20mg once daily for 14 days and Ticagrelor 90mg twice daily for 14 days

    Subject analysis set title
    Pharmacodynamic analysis set Aspririn 20mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients randomised to receive study medication when receiving Aspirin 20mg

    Subject analysis set title
    Pharmacodynamic analysis set Aspirin 75mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients that received Aspirin 75mg

    Primary: Serum thromboxane

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    End point title
    		 Serum thromboxane
    End point description
    End point type
    Primary
    End point timeframe
    In steady state after 14 days of treatment after two hours following the last dose of the period
    End point values
    		 Pharmacodynamic analysis set Aspririn 20mg Pharmacodynamic analysis set Aspirin 75mg
    Number of subjects analysed
    20
    20
    Units: nanogram(s)
        arithmetic mean (standard deviation)
    3.03 ± 3.64
    0.83 ± 1.93
    Statistical analysis title
    		 Overall analysis
    Statistical analysis description
    Post-dose serum TXB2 results for participants when receiving aspirin 20 mg twice daily vs. 75 mg once daily were analysed using a two-tailed paired t-test (3.03 ± 3.64 ng/ml vs. 0.83 ± 1.93 ng/ml, p=0.018).
    Comparison groups
    Pharmacodynamic analysis set Aspririn 20mg v Pharmacodynamic analysis set Aspirin 75mg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.018
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Bleeding time

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    End point title
    		 Bleeding time
    End point description
    End point type
    Secondary
    End point timeframe
    After each 14 day treatment period. Two hours after last dose
    End point values
    		 Pharmacodynamic analysis set Aspririn 20mg Pharmacodynamic analysis set Aspirin 75mg
    Number of subjects analysed
    20
    20
    Units: second
        arithmetic mean (standard deviation)
    679.5 ± 305.5
    833.9 ± 385.7
    No statistical analyses for this end point

    Secondary: Pre-dose serum thomboxane serum 2

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    End point title
    		 Pre-dose serum thomboxane serum 2
    End point description
    End point type
    Secondary
    End point timeframe
    After 14 days of treatment and before the last dose
    End point values
    		 Pharmacodynamic analysis set Aspririn 20mg Pharmacodynamic analysis set Aspirin 75mg
    Number of subjects analysed
    20
    20
    Units: nanogram(s)
        arithmetic mean (standard deviation)
    3.51 ± 4.07
    2.48 ± 3.14
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From enrollment to day 42 phone call
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Aspiring 20mg regime
    Reporting group description
    		 -

    Reporting group title
    Aspiring 75mg regime
    Reporting group description
    		 -

    Serious adverse events
    		 Aspiring 20mg regime Aspiring 75mg regime
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Aspiring 20mg regime Aspiring 75mg regime
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 20 (20.00%)
    General disorders and administration site conditions
    Epistaxis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Haematoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Chest discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    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
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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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