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    Clinical Trial Results:
    Study of two regimens of TicagrElor compared to clopidogrel in patients undergoing ELective Percutaneous Coronary Intervention (STEEL PCI)

    Summary
    EudraCT number
    		 2014-004783-38
    Trial protocol
    		 GB  
    Global end of trial date
    31 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    STH18423
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02327624
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    Trust Headquarters, 8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    Scientific contact
    Dr Dipak Patel, Sheffield Teaching Hospitals NHS Foundation Trust, sth.ResearchAdministration@nhs.net
    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
    31 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the effects of a single loading regimen and two different maintenance regimens of ticagrelor on erythrocyte adenosine reuptake compared with standard regimens of clopidogrel.
    Protection of trial subjects
    Participants were regularly monitored by research staff post - procedure in appointments at the research facility and phone calls. An SOP was designed to aid the transition from ticagrelor to clopidogrel where necessary and follow up phonecalls confirmed that the patients were able to get repeat prescriptions from their GP.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jun 2015
    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: 180
    Worldwide total number of subjects
    180
    EEA total number of subjects
    180
    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)
    87
    From 65 to 84 years
    93
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 180 patients were recruited from the PCI pre assessment clinic.

    Pre-assignment
    Screening details
    		 Patients over the age of 18 were considered if listed for a PCI. Exclusion criteria such as no previous MI, no medication issues, no extreme bleeding events and fitness to participate were assessed prior to enrolment.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ticagrelor 60 mg
    Arm description
    		 Patients randomised to ticagrelor 180 mg loading dose 2 hours prior to PCI then 60 mg BD of ticagrelor for 1 month.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor 60 mg
    Investigational medicinal product code
    274693-27-5
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    180 mg loading dose 2 hours prior to PCI then 60 mg BD for one month

    Arm title
    		 Ticagrelor 90 mg
    Arm description
    		 Patients randomised to 180 mg ticagrelor loading dose 2 hours prior to PCI then 90 mg ticagrelor BD for 1 month.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor 90 mg
    Investigational medicinal product code
    274693-27-5
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    180 mg ticagrelor given as loading dose a minimum of 2 hours prior to PCI then ticagrelor 90 mg BD for 1 month

    Arm title
    		 Clopidogrel
    Arm description
    		 Standard of care- patients randomised to this arm received a standard loading dose of clopidogrel prior to PCI followed by 1 month clopidogrel 75 md OD.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clopidogrel 75 mg
    Investigational medicinal product code
    113665-84-2
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Standard of care- patients randomised to this arm received a standard loading dose of clopidogrel prior to PCI followed by 1 month clopidogrel 75 md OD.

    Number of subjects in period 1
    		Ticagrelor 60 mg Ticagrelor 90 mg Clopidogrel
    Started
    60
    60
    60
    Enrolment
    60
    60
    60
    Randomisation
    60
    60
    60
    Visits 3 to 5
    55
    51
    56
    Visit 6
    54
    48
    53
    Completed
    54
    48
    53
    Not completed
    6
    12
    7
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    5
    2
    3
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    1
         Did not proceed to PCI
    1
    8
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ticagrelor 60 mg
    Reporting group description
    		 Patients randomised to ticagrelor 180 mg loading dose 2 hours prior to PCI then 60 mg BD of ticagrelor for 1 month.

    Reporting group title
    Ticagrelor 90 mg
    Reporting group description
    		 Patients randomised to 180 mg ticagrelor loading dose 2 hours prior to PCI then 90 mg ticagrelor BD for 1 month.

    Reporting group title
    Clopidogrel
    Reporting group description
    		 Standard of care- patients randomised to this arm received a standard loading dose of clopidogrel prior to PCI followed by 1 month clopidogrel 75 md OD.

    Reporting group values
    		 Ticagrelor 60 mg Ticagrelor 90 mg Clopidogrel Total
    Number of subjects
    		 60 60 60 180
    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)
    		 66.9 ± 8.6 66.0 ± 7.7 64.6 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    		 11 9 14 34
        Male
    		 49 51 46 146
    Subject analysis sets

    Subject analysis set title
    Efficacy Analysis Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomised patients who attended hospital for their planned PCI procedure and received a loading dose of study medication (unless randomised to clopidogrel and having received more than 5 days maintenance therapy and/or a loading dose prior to admission in which case hospital attendance for the PCI procedure will be the criterion for inclusion).

    Subject analysis sets values
    		 Efficacy Analysis Set
    Number of subjects
    162
    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)
    66 ± 8
    Gender categorical
    Units: Subjects
        Female
    30
        Male
    132

    End points

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    End points reporting groups
    Reporting group title
    Ticagrelor 60 mg
    Reporting group description
    		 Patients randomised to ticagrelor 180 mg loading dose 2 hours prior to PCI then 60 mg BD of ticagrelor for 1 month.

    Reporting group title
    Ticagrelor 90 mg
    Reporting group description
    		 Patients randomised to 180 mg ticagrelor loading dose 2 hours prior to PCI then 90 mg ticagrelor BD for 1 month.

    Reporting group title
    Clopidogrel
    Reporting group description
    		 Standard of care- patients randomised to this arm received a standard loading dose of clopidogrel prior to PCI followed by 1 month clopidogrel 75 md OD.

    Subject analysis set title
    Efficacy Analysis Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomised patients who attended hospital for their planned PCI procedure and received a loading dose of study medication (unless randomised to clopidogrel and having received more than 5 days maintenance therapy and/or a loading dose prior to admission in which case hospital attendance for the PCI procedure will be the criterion for inclusion).

    Primary: In vitro adenosine uptake at PCI

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    End point title
    		 In vitro adenosine uptake at PCI
    End point description
    End point type
    Primary
    End point timeframe
    At PCI
    End point values
    		 Ticagrelor 60 mg Ticagrelor 90 mg Clopidogrel
    Number of subjects analysed
    54
    51
    57
    Units: micromole(s)/litre
        arithmetic mean (standard deviation)
    0.288 ± 0.10
    0.278 ± 0.15
    0.274 ± 0.133
    Statistical analysis title
    		 T Test
    Comparison groups
    Ticagrelor 90 mg v Clopidogrel
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Proportion of non-responders defined as PRU greater than 208.

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    End point title
    		 Proportion of non-responders defined as PRU greater than 208.
    End point description
    End point type
    Secondary
    End point timeframe
    Post loading dose.
    End point values
    		 Ticagrelor 60 mg Ticagrelor 90 mg Clopidogrel
    Number of subjects analysed
    53
    57
    59
    Units: Patients
    1
    0
    18
    Statistical analysis title
    		 T Test
    Comparison groups
    Clopidogrel v Ticagrelor 60 mg
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T Test
    Comparison groups
    Clopidogrel v Ticagrelor 90 mg
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: PRU (CYP2C19 loss of function carrier)

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    End point title
    		 PRU (CYP2C19 loss of function carrier)
    End point description
    End point type
    Secondary
    End point timeframe
    1 month post dose.
    End point values
    		 Ticagrelor 60 mg Ticagrelor 90 mg Clopidogrel
    Number of subjects analysed
    16
    8
    16
    Units: PRU
        arithmetic mean (standard deviation)
    35 ± 25
    8 ± 3
    176 ± 60
    No statistical analyses for this end point

    Secondary: PRU (CYP2C19 no loss of function)

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    End point title
    		 PRU (CYP2C19 no loss of function)
    End point description
    End point type
    Secondary
    End point timeframe
    1 month post dose.
    End point values
    		 Ticagrelor 60 mg Ticagrelor 90 mg Clopidogrel
    Number of subjects analysed
    35
    39
    36
    Units: PRU
        arithmetic mean (standard deviation)
    32 ± 32
    27 ± 22
    155 ± 49
    No statistical analyses for this end point

    Secondary: Periprocedural Myocardial Infarction

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    End point title
    		 Periprocedural Myocardial Infarction
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours post procedure.
    End point values
    		 Ticagrelor 60 mg Ticagrelor 90 mg Clopidogrel Efficacy Analysis Set
    Number of subjects analysed
    54
    51
    57
    162
    Units: Patients
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 month.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Ticagrelor 60
    Reporting group description
    		 -

    Reporting group title
    Ticagrelor 90
    Reporting group description
    		 -

    Reporting group title
    Clopidogrel
    Reporting group description
    		 -

    Serious adverse events
    		 Ticagrelor 60 Ticagrelor 90 Clopidogrel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 56 (12.50%)
    6 / 58 (10.34%)
    5 / 60 (8.33%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Radial artery injury
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute massive pulmonary embolism
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Heart racing
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain - cardiac
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain exertional
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vasovagal symptoms
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Vessel puncture site haemorrhage
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 58 (1.72%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain (non-cardiac)
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Swelling arm
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Bowel ischaemia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ticagrelor 60 Ticagrelor 90 Clopidogrel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 56 (37.50%)
    27 / 58 (46.55%)
    9 / 60 (15.00%)
    Injury, poisoning and procedural complications
    Bruising
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 58 (1.72%)
    2 / 60 (3.33%)
         occurrences all number
    1
    1
    2
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    Pre-syncope
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 56 (5.36%)
    6 / 58 (10.34%)
    2 / 60 (3.33%)
         occurrences all number
    3
    6
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Gastrointestinal discomfort
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 58 (3.45%)
    3 / 60 (5.00%)
         occurrences all number
    3
    2
    3
    Reproductive system and breast disorders
    Haematospermia
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 58 (3.45%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 56 (7.14%)
    11 / 58 (18.97%)
    0 / 60 (0.00%)
         occurrences all number
    4
    11
    0
    Epistaxis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    Shingles
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 58 (1.72%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    1

    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/29930021
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