Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Prolonged ENoxapariN in primarY percutaneous coronary intervention compared WIth Standard-of-carE therapy: Feasibility study (PENNYWISE Feasibility)

    Summary
    EudraCT number
    		 2018-000774-30
    Trial protocol
    		 GB  
    Global end of trial date
    09 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2023
    First version publication date
    23 Aug 2023
    Other versions
    Summary report(s)
    		 Prolonged enoxaparin therapy compared with standard-of-care antithrombotic therapy in opiate-treated patients undergoing primary percutaneous coronary intervention

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    STH19902
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03568838
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Angela Pinder, Sheffield Teaching Hospitals NHS Foundation Trust, angela.pinder@nhs.net
    Scientific contact
    Angela Pinder, Sheffield Teaching Hospitals NHS Foundation Trust, angela.pinder@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
    21 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a feasibility study with the objective to establish the practically possible recruitment rate into the study. The other primary objective is to collect more pilot data on bleeding events within the first 24 hours and compare those between the two treatment arms.
    Protection of trial subjects
    Study samples minimised to assess important endpoints but avoid undue discomfort.
    Background therapy
    		 Dual antiplatelet therapy with a loading dose of 300mg of Aspirin and Ticagrelor or Prasugrel. All participants received Morphine or Diamorphine. 83% had received an antiemetic.
    Evidence for comparator
    		 The comparator arm was Standard of Care in our institution.
    Actual start date of recruitment
    28 Jun 2018
    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: 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)
    20
    From 65 to 84 years
    78
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment from 06/07/2018 to 09/03/2019, in a single UK centre.

    Pre-assignment
    Screening details
    		 During the screening period all patients attending the centre for Primary PCI were screened for eligibility to participate in the study, with an Investigator verbally consenting those eligible prior to their procedure as per the protocol. Written consent was subsequently achieved upon completion of the initial procedure at an appropriate time.

    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
    		 Enoxaparin
    Arm description
    		 Patients randomised to Enoxaparin arm given 0.75mg/kg intraarterial bolus plus 0.75mg/kg intravenous infusion over 6 hours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enoxaparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use , Intraarterial use
    Dosage and administration details
    Enoxaparin 0.75mg/kg bolus plus 0.75mg/kg infusion over 6 hours.

    Arm title
    		 Unfractionated Heparin +/- Tirofiban
    Arm description
    		 Standard of care for Primary PCI patients.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Unfractionated Heparin +/- Tirofiban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intraarterial use, Intravenous drip use
    Dosage and administration details
    Unfractionated Heparin- 50-70iu/kg Tirofiban- 25ug/kg for 3 minutes followed by 0.125ug/kg per minute for 6 hours.

    Number of subjects in period 1
    		Enoxaparin Unfractionated Heparin +/- Tirofiban
    Started
    50
    50
    Completed
    50
    49
    Not completed
    0
    1
         Adverse event, serious fatal
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Enoxaparin
    Reporting group description
    		 Patients randomised to Enoxaparin arm given 0.75mg/kg intraarterial bolus plus 0.75mg/kg intravenous infusion over 6 hours.

    Reporting group title
    Unfractionated Heparin +/- Tirofiban
    Reporting group description
    		 Standard of care for Primary PCI patients.

    Reporting group values
    		 Enoxaparin Unfractionated Heparin +/- Tirofiban Total
    Number of subjects
    		 50 50 100
    Age categorical
    Age of participant at time of consent.
    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)
    		 31 33 64
        From 65-84 years
    		 18 17 35
        85 years and over
    		 1 0 1
    Gender categorical
    Units: Subjects
        Female
    		 20 11 31
        Male
    		 30 39 69
    Smoking Status
    Smoking status- current/past or none
    Units: Subjects
        None
    		 17 13 30
        Current/Past
    		 33 37 70
    Call to balloon time
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    		 128 (110 to 161) 126 (105 to 182) -
    Subject analysis sets

    Subject analysis set title
    Efficacy/safety analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised participants who proceeded to angiography.

    Subject analysis sets values
    		 Efficacy/safety analysis set
    Number of subjects
    99
    Age categorical
    Age of participant at time of consent.
    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)
    63
        From 65-84 years
    35
        85 years and over
    1
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    31
        Male
    68
    Smoking Status
    Smoking status- current/past or none
    Units: Subjects
        None
    30
        Current/Past
    69
    Call to balloon time
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    126 (106 to 193)

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Enoxaparin
    Reporting group description
    		 Patients randomised to Enoxaparin arm given 0.75mg/kg intraarterial bolus plus 0.75mg/kg intravenous infusion over 6 hours.

    Reporting group title
    Unfractionated Heparin +/- Tirofiban
    Reporting group description
    		 Standard of care for Primary PCI patients.

    Subject analysis set title
    Efficacy/safety analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised participants who proceeded to angiography.

    Primary: Determine feasibility of conducting a bigger study

    		 Close Top of page
    End point title
    		 Determine feasibility of conducting a bigger study [1]
    End point description
    Recruitment rate over the study period.
    End point type
    Primary
    End point timeframe
    Duration of study.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study protocol stated that the intention of this feasibility study was to determine potential recruitment rate. The recruitment target was met well within 1 year, supporting further studies of this type.
    End point values
    		 Enoxaparin Unfractionated Heparin +/- Tirofiban
    Number of subjects analysed
    50
    49
    Units: Number enrolled
    50
    49
    No statistical analyses for this end point

    Primary: Collect pilot data on bleeding events

    		 Close Top of page
    End point title
    		 Collect pilot data on bleeding events [2]
    End point description
    Collect pilot data on bleeding events within the first 24 hours post procedure and compare between the two treatment arms. Trivial bleeding related to access site disregarded. Bleeding events will be categorised according to BARC types BARC2 - BARC5.
    End point type
    Primary
    End point timeframe
    Bleeding rates at 24 hour timepoint.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: three bleeding events were recorded. One BARC2 event in the SOC group and two BARC1 events in the experimental group
    End point values
    		 Enoxaparin Unfractionated Heparin +/- Tirofiban
    Number of subjects analysed
    50
    50
    Units: absolute number
    2
    1
    No statistical analyses for this end point

    Secondary: Acute stent thrombosis rate

    		 Close Top of page
    End point title
    		 Acute stent thrombosis rate
    End point description
    Acute stent thrombosis rates within the first 24 hours post procedure will be recorded for each treatment arm, and the two groups compared.
    End point type
    Secondary
    End point timeframe
    Within first 24 hours post procedure.
    End point values
    		 Enoxaparin Unfractionated Heparin +/- Tirofiban
    Number of subjects analysed
    50
    50
    Units: absolute number
    0
    2
    No statistical analyses for this end point

    Secondary: Rate of ST segment resolution

    		 Close Top of page
    End point title
    		 Rate of ST segment resolution
    End point description
    Rates of ST-segment resolution will be calculated by comparing the presentation ECG and the ECG taken 1hr post procedure. The rates of ST-segment resolution will be compared between the two treatment groups.
    End point type
    Secondary
    End point timeframe
    Rate of ST-segment resolution will be calculated using the presentation ECG and 1hr post PPCI ECG.
    End point values
    		 Enoxaparin Unfractionated Heparin +/- Tirofiban
    Number of subjects analysed
    50
    50
    Units: percentage resolution
        number (not applicable)
    50
    49
    Statistical analysis title
    		 Percentage resolution
    Statistical analysis description
    Percentage ST segment resolution within 1 hour following primary percutaneous intervention
    Comparison groups
    Enoxaparin v Unfractionated Heparin +/- Tirofiban
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.44 [3]
    Method
    		 Chi-squared
    Parameter type
    		 Median difference (final values)
    Confidence interval
    Notes
    [3] - no significant difference between groups

    Secondary: Rates of composite outcome of myocardial infarction

    		 Close Top of page
    End point title
    		 Rates of composite outcome of myocardial infarction
    End point description
    Rates of the composite outcome of recurrent myocardial infarction, ischaemic stroke or cardiovascular death within 30 days of STEMI will be recorded, and the two treatment groups compared.
    End point type
    Secondary
    End point timeframe
    Within 30 days of STEMI
    End point values
    		 Enoxaparin Unfractionated Heparin +/- Tirofiban
    Number of subjects analysed
    50
    50
    Units: absolute number
    0
    2
    No statistical analyses for this end point

    Secondary: 1 year mortality rates

    		 Close Top of page
    End point title
    		 1 year mortality rates
    End point description
    1 year mortality rates will be compared between the two groups.
    End point type
    Secondary
    End point timeframe
    1 year post procedure
    End point values
    		 Enoxaparin Unfractionated Heparin +/- Tirofiban
    Number of subjects analysed
    50
    50
    Units: absolute number
    3
    1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events will be reported from randomisation until 24 hours post PPCI for all participants in this study. Any AE deemed an SAE will be reported to the sponsor within 24 hours of the study team becoming aware.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Unfractionated Heparin +/- Tirofiban
    Reporting group description
    		 Participants presenting with STEMI treated with an opiate were randomised to standard of care. This group received treatment at the discretion of their cardiologist consisting of a weight adjusted bolus dose of UFH 50-70 IU/kg + a 6 hour regimen of tirofiban (or UFH 70 IU/kg alone if concerns about bleeding risk). The tirofiban regimen consisted of 25 mcg/kg over 3 mins (or 6 mins if weight > 120kg) followed by maintenance dose of 0.15 mcg/kg/min for patients with eGFR more than or equal to 30ml/min/1.73m2 for 6 hours. Half of the aforementioned tirofiban doses were used for patients with an eGFR less than 30 mcg/kg/1.73m2.

    Reporting group title
    Enoxaparin
    Reporting group description
    		 Participants presenting with STEMI who had been treated with opiates randomised to receive an intra-arterial bolus (0.75mg/kg) of enoxaparin followed by intravenous infusion of enoxaparin 0.75mg/kg/6 hours.

    Serious adverse events
    		 Unfractionated Heparin +/- Tirofiban Enoxaparin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    0
    Cardiac disorders
    Coronary stent thrombosis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Unfractionated Heparin +/- Tirofiban Enoxaparin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 50 (4.00%)
    General disorders and administration site conditions
    Gingival bleeding
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    GI bleed
    Additional description: upper GI bleed
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    rash
    Additional description: Rash on torso
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    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/32543247
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 02 22:31:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA