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    Clinical Trial Results:
    Prolonged ENoxapariN in primarY Percutaneous Coronary Intervention; a Pilot Pharmacodynamic study (PENNY PCI study)

    Summary
    EudraCT number
    		 2017-000485-29
    Trial protocol
    		 GB  
    Global end of trial date
    30 Mar 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    STH19752
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03146858
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shefifeld Teaching Hospitals NHS FT
    Sponsor organisation address
    Glossop Road, Sheffield, United Kingdom, S10 2JF
    Public contact
    Nana Theodorou, STH NHS FT, 0114 2712763, nana.theodorou@sth.nhs.uk
    Scientific contact
    Nana Theodorou, STH NHS FT, 0114 2712763, nana.theodorou@sth.nhs.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
    31 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to study the pharmacodynamic effects of a novel regimen of enoxaparin (a bolus followed by an infusion) in patients presenting with STEMI. The primary outcome measure was anti Xa activity. The aim of this regimen is to offer sufficient antithrombotic effect in order to bridge treatment with oral therapy.
    Protection of trial subjects
    The trial protocol has been independently reviewed. All approvals were obtained before commencing recruitment. Study was completed according to the principles set in Good Clinical Practice.
    Background therapy
    		 Not applicable as there was no requirements for the patient to be on any other drugs.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jun 2017
    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: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    11
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Potential participants were identified by the clinical team directly involved in their care. Upon identification of eligible patients, the clinical research team was informed.

    Pre-assignment
    Screening details
    		 Each patient entering the study was screened for all of the inclusion criteria and had none of the exclusion criteria. The Principal Investigator or a medically qualified co investigator will confirm eligibility for the study. All the exclusion criteria are usually checked routinely as part of routine clinical practice.

    Period 1
    Period 1 title
    Medication period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Enoxaparin
    Arm description
    		 Bolus followed by infusion intraarterial enoxaparin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enoxaparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Anticoagulant and preservative solution for blood
    Routes of administration
    Intracoronary use, Intravenous use
    Dosage and administration details
    A bolus of IA/IV enoxaparin 0.75 mg/kg (pre PCI) followed by an IV infusion of 0.75 mg/kg over 6 hours.

    Number of subjects in period 1
    		Enoxaparin
    Started
    22
    Completed
    19
    Not completed
    3
         Physician decision
    1
         Received different treatment to latest protocol
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Medication period
    Reporting group description
    		 The protocol was amended after the second patient as anti Xa levels were found to be low (0.51 IU/ml). Results reported in this report are for the 20 patients who received the updated protocol recommended treatment (0.75 mg/kg of IA enoxaparin followed by 0.75 mg/kg/6h infusion).

    Reporting group values
    		 Medication period Total
    Number of subjects
    		 22 22
    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)
    		 66.2 ( 10.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 18 18
    Subject analysis sets

    Subject analysis set title
    Pharmacodynamic analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled patients that received enoxaparin for the dose and duration specified in the latest version of the protocol

    Subject analysis sets values
    		 Pharmacodynamic analysis
    Number of subjects
    19
    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)
    67.0 ( 10.8 )
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    16

    End points

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    End points reporting groups
    Reporting group title
    Enoxaparin
    Reporting group description
    		 Bolus followed by infusion intraarterial enoxaparin

    Subject analysis set title
    Pharmacodynamic analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled patients that received enoxaparin for the dose and duration specified in the latest version of the protocol

    Primary: Anti-Xa activity

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    End point title
    		 Anti-Xa activity
    End point description
    End point type
    Primary
    End point timeframe
    Time point 1 (T1) prior to anticoagulation – at the start of PCI procedure. Time point 2 (T2) at the end of PPCI. Time point 3 (T3) 2-3 hours from the start of enoxaparin infusion. Time point 4 (T4) at the end of enoxaparin infusion.
    End point values
    		 Enoxaparin Pharmacodynamic analysis
    Number of subjects analysed
    19 [1]
    19
    Units: iu/ml
        arithmetic mean (standard deviation)
    1.003 ( 0.06 )
    1.003 ( 0.06 )
    Notes
    [1] - Reporting the primary end point after 6 hours
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    One-way analysis of variance (ANOVA) was used for assessment of continuous variables. Variance during the infusion was assessed using one-way analysis of variance (ANOVA) with Dunnett's multiple comparison tests . Six hours versus 2 to 3 hours; p = 0.6 and 6 hours versus post-PCI; p = 0.09
    Comparison groups
    Enoxaparin v Pharmacodynamic analysis
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.09 [2]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Notes
    [2] - 6 hours versus post-PCI; p = 0.09

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    14 hours after the start of the infusion
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Pharmacodynamic set
    Reporting group description
    		 -

    Reporting group title
    Medication arm
    Reporting group description
    		 The 22 subjects enrolled

    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: In this study there were no reported non-serious adverse events.
    Serious adverse events
    		 Pharmacodynamic set Medication arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    10063933
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pharmacodynamic set Medication arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2017
    Temporary halt
    17 Jul 2017
    SA02 to update procotol and re start the trial

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    26 Jun 2017
    The second patient suffered a stent thrombosis in the context of a long segment of underdeployed stent. DMC were informed and we halted the trial. Anti Xa levels were 0.51 IU/ml. We therefore increased the enoxaparin dose to 0.75 mg/kg bolus followed by 0.75 mg/kg/6h infusion.
    25 Aug 2017

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The protocol was amended after the second patient as anti Xa levels were found to be low (0.51 IU/ml). Results reported in this report are for the 20 patients who received the updated protocol recommended treatment (0.75 mg/kg of IA enoxaparin follow
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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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