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    Clinical Trial Results:
    The Effect of Intravenous Cangrelor and Oral Ticagrelor on Platelets, the Microcirculation and Myocardial Damage in Patients admitted with STEMI Treated by Primary Percutaneous Coronary Intervention A randomized controlled pilot trial

    Summary
    EudraCT number
    		 2016-000195-19
    Trial protocol
    		 GB  
    Global end of trial date
    31 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2015CAR77
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02733341
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Royal Wolverhampton NHS Trust
    Sponsor organisation address
    Research & Development Directorate, The Chestnuts, Wolverhampton, United Kingdom, WV10 0QP
    Public contact
    Lorraine Jacques, The Royal Wolverhampton NHS Trust, 01902 695065, lorraine.jacques@nhs.net
    Scientific contact
    Sarah Glover, The Royal Wolverhampton NHS Trust, 1902 695065, sarah.glover7@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 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the degree and time-course of platelet inhibition in patients admitted with STEMI treated with IV Cangrelor vs oral Ticagrelor. To assess the impact of Cangrelor vs Ticagrelor on the index of myocardial microcirculatory resistance using IMR. To investigate the impact of Cangrelor vs Ticagrelor on markers of PPCI success (TIMI flow grade assessment to evaluate coronary blood flow after PPCI). To assess ST segment resolution post PPCI. To investigate the impact of Cangrelor vs Ticagrelor on initial myocardial infarct size based on Peak Troponin. To investigate the impact of Cangrelor vs Ticagrelor on final myocardial infarct size by CMR at three months post PPCI.
    Protection of trial subjects
    Trial management group utilised.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jul 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: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    0
    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)
    58
    From 65 to 84 years
    37
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of subjects start: 21/07/16, end 28/01/17 in a single centre, UK

    Pre-assignment
    Screening details
    		 Patients treated with GP IIb/IIIa receptor antagonist therapy during the primary PCI were withdrawn from the analysis.

    Pre-assignment period milestones
    Number of subjects started
    		 117 [1]
    Number of subjects completed
    		 100

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 the use of GPIIb/IIIa inhibitors: 11
    Reason: Number of subjects
    		 extreme clinical instability: 2
    Reason: Number of subjects
    		 presence of an alternative diagnosis: 4
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Seventeen subjects were withdrawn from the study after randomization
    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
    		 Cangrelor
    Arm description
    		 IV cangrelor drug arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cangrelor
    Investigational medicinal product code
    B01AC25
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cangrelor was administered at a rate of 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion. The bolus and infusion will be initiated in the cardiac catheter lab prior to the PCI procedure and continued for at least two hours or for the duration of the procedure (to increase up to three hours), whichever is longer.

    Arm title
    		 Ticagrelor
    Arm description
    		 Patients allocated to ticagrelor received a loading dose of 180mg of the drug orally immediately following randomization and prior to admission to the catheter suite. They then continued a maintenance dose of 90mg twice daily for 12 months as per standard clinical practice.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ticagrelor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients allocated to ticagrelor received a loading dose of 180mg of the drug orally immediately following randomization and prior to admission to the catheter suite. They then continued a maintenance dose of 90mg twice daily for 12 months as per standard clinical practice.

    Number of subjects in period 1
    		Cangrelor Ticagrelor
    Started
    50
    50
    Completed
    50
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cangrelor
    Reporting group description
    		 IV cangrelor drug arm

    Reporting group title
    Ticagrelor
    Reporting group description
    		 Patients allocated to ticagrelor received a loading dose of 180mg of the drug orally immediately following randomization and prior to admission to the catheter suite. They then continued a maintenance dose of 90mg twice daily for 12 months as per standard clinical practice.

    Reporting group values
    		 Cangrelor Ticagrelor Total
    Number of subjects
    		 50 50 100
    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)
    		 27 31 58
        From 65-84 years
    		 22 15 37
        85 years and over
    		 1 4 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.2 ( 13.9 ) 63.4 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 17 28
        Male
    		 39 33 72

    End points

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    End points reporting groups
    Reporting group title
    Cangrelor
    Reporting group description
    		 IV cangrelor drug arm

    Reporting group title
    Ticagrelor
    Reporting group description
    		 Patients allocated to ticagrelor received a loading dose of 180mg of the drug orally immediately following randomization and prior to admission to the catheter suite. They then continued a maintenance dose of 90mg twice daily for 12 months as per standard clinical practice.

    Primary: P2Y12 reaction units at balloon inflation time

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    End point title
    		 P2Y12 reaction units at balloon inflation time
    End point description
    End point type
    Primary
    End point timeframe
    At balloon inflation time
    End point values
    		 Cangrelor Ticagrelor
    Number of subjects analysed
    50
    50
    Units: P2Y12 reaction units
        arithmetic mean (standard deviation)
    145.2 ( 50.6 )
    248.3 ( 55.1 )
    Statistical analysis title
    		 PRU at balloon inflation time
    Comparison groups
    Cangrelor v Ticagrelor
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: platelet inhibition at 4 hours

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    End point title
    		 platelet inhibition at 4 hours
    End point description
    End point type
    Primary
    End point timeframe
    4 hours after balloon inflation
    End point values
    		 Cangrelor Ticagrelor
    Number of subjects analysed
    50
    50
    Units: P2Y12 reaction units
        arithmetic mean (standard deviation)
    158.1 ( 92.1 )
    131.2 ( 92.9 )
    Statistical analysis title
    		 PRU 4 hours after balloon inflation time
    Comparison groups
    Cangrelor v Ticagrelor
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.15
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Platelet inhibition at at 24-36 hours

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    End point title
    		 Platelet inhibition at at 24-36 hours
    End point description
    End point type
    Primary
    End point timeframe
    24-36 hours after balloon inflation
    End point values
    		 Cangrelor Ticagrelor
    Number of subjects analysed
    50
    50
    Units: P2Y12 reaction units
        arithmetic mean (standard deviation)
    61.0 ( 50.0 )
    60.1 ( 56.3 )
    Statistical analysis title
    		 PRU 24-36 hours after balloon inflation time
    Comparison groups
    Cangrelor v Ticagrelor
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.93
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    FROM RECRUITMENT UNTIL PATIENTS DISCHARGE FROM HOSPITAL
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Cangrelor
    Reporting group description
    		 IV cangrelor drug arm

    Reporting group title
    Ticagrelor
    Reporting group description
    		 Patients allocated to ticagrelor received a loading dose of 180mg of the drug orally immediately following randomization and prior to admission to the catheter suite. They then continued a maintenance dose of 90mg twice daily for 12 months as per standard clinical practice.

    Serious adverse events
    		 Cangrelor Ticagrelor
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    acute pulmonary oedema
    Additional description: Acute Pulmonary Oedema, needed CPAP/Intubation and Acute Ischemic MVR led to MVR Prosthetic + single graft to OM.
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cangrelor Ticagrelor
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 50 (8.00%)
    General disorders and administration site conditions
    hematoma
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    2
    3
    Respiratory, thoracic and mediastinal disorders
    shortness of breath
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2016
    Addition of a poster

    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.
    The principal limitation of this study is its sample size. While adequately powered for the P2Y12 related endpoints, the results of surrogate endpoints do not provide convincing data and should be interpreted as hypothesis generating

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31129911
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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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