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    Clinical Trial Results:
    Antiplatelet treatment in patients with diabetes mellitus: is there a difference between aspirin, clopidogrel and prasugrel

    Summary
    EudraCT number
    2009-011907-22
    Trial protocol
    GB  
    Global end of trial date
    31 Mar 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    09 May 2020
    First version publication date
    09 May 2020
    Other versions
    Summary report(s)
    Antiplatelet in Diabetes final report

    Trial information

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    Trial identification
    Sponsor protocol code
    ED09/8912
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Worsley Building, Leeds, United Kingdom, LS2 9JT
    Public contact
    Dr Ramzi Ajjan, University of Leeds, R.Ajjan@leeds.ac.uk
    Scientific contact
    Dr Ramzi Ajjan, University of Leeds, R.Ajjan@leeds.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
    31 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the biochemical efficacy of Aspirin, Clopidegrel and Prasugrel in subjects with type 2 diabetes using a dual approach that investigates both platelet function and clot structure/fibrinolysis
    Protection of trial subjects
    This clinical trial, which involves the use of a medicinal product has been designed and will be run in accordance with the Principles of GCP and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004 / 1031) and any subsequent amendments of the clinical trial regulations.. The right of any individual to refuse consent without giving reasons will be respected. Furthermore, the patient will remain free to withdraw from the study at any time without giving reasons and without prejudicing any further treatment. Each participant will be involved in the study for a maximum of 10 weeks. Patients will need to attend on 5 occasions. Additional visits will be arranged at subject request or if this is deemed clinically necessary. AEs will be collected for all patients and will be evaluated for duration and intensity according to the NCRI Common Toxicity Criteria.
    Background therapy
    Diabetes is associated with increased risk of vascular disease, including heart attack and strokes 1. People with diabetes also have a worse short and long term prognosis following a heart attack with a higher death rate, when compared to non-diabetics 2. Antiplatelet therapy is an established management strategy for secondary prevention from cardiovascular events in people with diabetes, although the role of this agent in primary prevention in these subjects remains unclear as the evidence is both limited and inconclusive. Aspirin and clopidogrel are the two main antiplatelet agents currently in use, and they differ in their mechanism of action. Aspirin affects platelet function by inhibiting an enzyme called cyclo-oxygenase 1, which is important for the production of proteins involved in platelet activation. Furthermore, aspirin has a direct effect on the structure of blood clots, making them easier to breakdown (lyse) 3. Clopidogrel also inhibits the function of platelets but uses a different pathway by directly inhibiting platelet function through its action on a special receptor called P2Y12. In contrast to aspirin, the effects of this agent on clot structure and function are unknown. Prasugrel, a new antiplatelet agent that has recently obtained marketing authorization and that is now marketed in the UK, has a similar mode of action compared with clopidogrel but seems to have a superior clinical efficacy 4, which is probably related to greater and more consistent inhibition of platelet activation 5.
    Evidence for comparator
    -
    Actual start date of recruitment
    29 May 2010
    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: 56
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were eligible to participate if they were aged 18–75 years, already on treatment with aspirin 75 mg once-daily (OD) and able to give informed consent.

    Pre-assignment
    Screening details
    Patients will be recruited in the diabetes centre at Leeds Teaching Hospitals Trust and specialist cardiovascular/diabetes clinics. A verbal explanation of the trial and an Information Sheet will be provided by Dr Ajjan for the subject to consider. This will include detailed information about the rationale, design and personal implications

    Period 1
    Period 1 title
    Main Trial Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg
    Arm description
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. This arm then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Aspirin 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. One half then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days, whilst the other half received prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 Days

    Investigational medicinal product name
    Clopidogrel 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. One half then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days, whilst the other half received prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 Days

    Investigational medicinal product name
    Prasugrel 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. One half then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days, whilst the other half received prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 Days

    Arm title
    Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Arm description
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. This arm thenreceived prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 days, in an alternate sequence to Arm 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Aspirin 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. One half then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days, whilst the other half received prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 Days

    Investigational medicinal product name
    Clopidogrel 75mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. One half then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days, whilst the other half received prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 Days

    Investigational medicinal product name
    Prasugrel 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. One half then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days, whilst the other half received prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 Days

    Number of subjects in period 1
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Started
    28
    28
    Completed
    28
    28

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Trial Period
    Reporting group description
    -

    Reporting group values
    Main Trial Period Total
    Number of subjects
    56 56
    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 (full range (min-max))
    60.7 (46 to 73) -
    Gender categorical
    Units: Subjects
        Female
    9 9
        Male
    47 47

    End points

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    End points reporting groups
    Reporting group title
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg
    Reporting group description
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. This arm then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days.

    Reporting group title
    Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Reporting group description
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. This arm thenreceived prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 days, in an alternate sequence to Arm 1.

    Primary: Prasugrel Maximum platelet aggregation response

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    End point title
    Prasugrel Maximum platelet aggregation response [1]
    End point description
    Please note, maximum platelet aggregation response is recorded on the system for the each treatment. not via each arm in the study, as treatment was identical, just at different time points. This is to accommodate the unusual design of the study. For more information on the end point data, please see the attached publication.
    End point type
    Primary
    End point timeframe
    please see attached publication for the details regarding periods of assesment
    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: Please see attached publication for details of all statistical analysis
    End point values
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Number of subjects analysed
    28
    28
    Units: 20μmol/L
        arithmetic mean (standard deviation)
    34.1 ± 14.1
    34.1 ± 14.1
    No statistical analyses for this end point

    Primary: Aspirin Maximum platelet aggregation response

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    End point title
    Aspirin Maximum platelet aggregation response [2]
    End point description
    Please note, maximum platelet aggregation response is recorded on the system for the each treatment. not via each arm in the study, as treatment was identical, just at different time points. This is to accommodate the unusual design of the study. For more information on the end point data, please see the attached publication.
    End point type
    Primary
    End point timeframe
    Please see attached publication for time frame details
    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: Please see attached publication for details of all statistical analysis
    End point values
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Number of subjects analysed
    28
    28
    Units: 20μmol/L
        arithmetic mean (standard deviation)
    77.6 ± 8.4
    77.6 ± 8.4
    No statistical analyses for this end point

    Primary: Clopidogrel Maximum platelet aggregation response

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    End point title
    Clopidogrel Maximum platelet aggregation response [3]
    End point description
    Please note, maximum platelet aggregation response is recorded on the system for the each treatment, not via each arm in the study, as treatment was identical, just at different time points. This is to accommodate the unusual design of the study. For more information on the end point data, please see the attached publication.
    End point type
    Primary
    End point timeframe
    Please see attached publication for all timeframe details
    Notes
    [3] - 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: Please see attached publication for details of all statistical analysis
    End point values
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Number of subjects analysed
    28
    28
    Units: 20μmol/L
        arithmetic mean (standard deviation)
    57.7 ± 17.6
    57.7 ± 17.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs will be collected for all patients at all visits, and will be evaluated for duration and intensity according to the NCRI Common Toxicity Criteria.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg
    Reporting group description
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. This arm then received clopidogrel 75 mg OD for 28 days then prasugrel 10 mg OD for 28 days.

    Reporting group title
    Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Reporting group description
    All patients continued aspirin 75 mg OD for an initial lead-in period of 14 days. This arm thenreceived prasugrel 10 mg OD for 28 days followed by clopidogrel 75 mg OD for 28 days, in an alternate sequence to Arm 1.

    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: Please see the attached final publication for details of Non-serious adverse events
    Serious adverse events
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Dizzyness
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Right Toe Ulcer
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Aspirin 75mg, Clopidogrel 75mg, Prasugrel 10mg Aspirin 75mg, Prasugrel 10mg, Clopidogrel 75mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2010
    PIS amended to v4.0, to include the contact details of a new research nurse joining the research team
    22 Jul 2011
    Protocol & PIS amended to versions 4.0 & 5.0.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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