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    Clinical Trial Results:
    Is cessation of clopidogrel therapy associated with rebound of platelet activity in stable vascular disease patients?

    Summary
    EudraCT number
    		 2007-007638-21
    Trial protocol
    		 GB  
    Global end of trial date
    24 Jul 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Aug 2018
    First version publication date
    19 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR2
    Additional study identifiers
    ISRCTN number
    		 ISRCTN77887299
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NHS Grampian
    Sponsor organisation address
    R&D Office, Foresterhill House Annexe, Aberdeen, United Kingdom, AB25 2ZB
    Public contact
    Gail Holland, NHS Grampian, 01224 555076, researchgovernance@abdn.ac.uk
    Scientific contact
    Gail Holland, NHS Grampian, 01224 555076, researchgovernance@abdn.ac.uk
    Sponsor organisation name
    University of Aberdeen
    Sponsor organisation address
    R&D Office, Foresterhill House Annexe, Aberdeen, United Kingdom, AB25 2ZB
    Public contact
    Professor Julie Brittenden, University of Aberdeen, 01224 551123, researchgovernance@abdn.ac.uk
    Scientific contact
    Professor Julie Brittenden, University of Aberdeen, 01224 551123, researchgovernance@abdn.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
    24 Jan 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of this study is to identify whether there is evidence for a "rebound" effect on platelet markers associated with cessation of clopidogrel therapy. We propose to address this in patients with stable cardiovascular disease by means of a mechanistic study.
    Protection of trial subjects
    Ethical approval was obtained (NOSRES 08/S0801/087), and each patient gave written informed consent.
    Background therapy
    		 The thienopyridine derivative, clopidogrel is an effective inhibitor of platelet activation and aggregation as a result of its selective and irreversible blockade of the P2Y12 receptor1. Combination antiplatelet therapy with clopidogrel and aspirin has been shown to be an effective strategy in patients with acute coronary syndromes and in those undergoing percutaneous interventions.
    Evidence for comparator
    		 A placebo group is included to determine whether any detected change in platelet activation is due to the clopidogrel therapy rather than changes that may occur over the course of the study in this population of patients.
    Actual start date of recruitment
    08 Oct 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: 172
    Worldwide total number of subjects
    172
    EEA total number of subjects
    172
    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)
    75
    From 65 to 84 years
    97
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who meet the criteria of the study will be identified from clinical databases of patients with stable vascular disease who have formerly attended the Cardiology and Vascular Surgery Unit at Aberdeen Royal Infirmary (ARI).

    Pre-assignment
    Screening details
    		 Participants will be invited by letter with information sheet enclosed. Prepaid envelope will be included to facilitate a reply. Those who reply positively will be offered an appointment by telephone by the research nurse and an opportunity to ask questions about the study.

    Period 1
    Period 1 title
    Clopidogrel vs Placebo (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
    		 Clopidogrel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Plavix
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg daily for 30 days (containing Clopidogrel tablets 75mg diluted with Lactose PhEur enclosed in a hard capsule shell).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    75mg daily for 30 days (containing Lactose PhEur 540mg to match the active)

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Clopidogrel Placebo
    Started
    88
    84
    Completed
    88
    84

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Clopidogrel vs Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Clopidogrel vs Placebo Total
    Number of subjects
    		 172 172
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 75 75
        From 65-84 years
    		 97 97
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 84 84
        Male
    		 88 88

    End points

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    End points reporting groups
    Reporting group title
    Clopidogrel
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: ADP -stimulated platelet fibrinogen binding

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    End point title
    		 ADP -stimulated platelet fibrinogen binding
    End point description
    End point type
    Primary
    End point timeframe
    Blood samples were taken at pre-treatment baseline, on treatment just before discontinuation of study drug, and on days 7, 14, and 28 after discontinuation.
    End point values
    		 Clopidogrel Placebo
    Number of subjects analysed
    88
    84
    Units: 10 umol/l
        number (not applicable)
    88
    84
    Statistical analysis title
    		 Final Results
    Statistical analysis description
    Descriptive results were produced for all outcomes, but statistical testing was only performed for the primary and secondary outcomes. The primary research question was addressed using a mixed model procedure, xt-mixed in Stata (21), using 7 models, 1 for each primary and secondary outcome measure, excluding the on-treatment timepoint but including baseline and 7, 14, and 28 days after treatment.
    Comparison groups
    Clopidogrel v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 24hrs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Total AE
    Reporting group description
    		 -

    Serious adverse events
    		 Total AE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 81 (3.70%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Chest pain
         subjects affected / exposed [1]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest tightness
         subjects affected / exposed [2]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Vasovagal
         subjects affected / exposed [3]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total AE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 81 (58.02%)
    Cardiac disorders
    Tightness in gullet/chest
         subjects affected / exposed [4]
    1 / 1 (100.00%)
         occurrences all number
    1
    Atrial fibrillation
         subjects affected / exposed [5]
    1 / 1 (100.00%)
         occurrences all number
    1
    Angina unstable
         subjects affected / exposed [6]
    1 / 1 (100.00%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed [7]
    1 / 1 (100.00%)
         occurrences all number
    1
    Myocardial infarction
    Additional description: Mild
         subjects affected / exposed [8]
    1 / 1 (100.00%)
         occurrences all number
    1
    Irregular heart beat
         subjects affected / exposed [9]
    1 / 1 (100.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Tooth infection
         subjects affected / exposed [10]
    1 / 1 (100.00%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed [11]
    1 / 1 (100.00%)
         occurrences all number
    1
    Shoulder pain
         subjects affected / exposed [12]
    3 / 3 (100.00%)
         occurrences all number
    3
    Bruising
         subjects affected / exposed [13]
    6 / 6 (100.00%)
         occurrences all number
    6
    Thigh pain
         subjects affected / exposed [14]
    1 / 1 (100.00%)
         occurrences all number
    1
    Increased sweats
         subjects affected / exposed [15]
    1 / 1 (100.00%)
         occurrences all number
    1
    swelling of polypoidas
         subjects affected / exposed [16]
    1 / 1 (100.00%)
         occurrences all number
    1
    Tiredness
         subjects affected / exposed [17]
    1 / 1 (100.00%)
         occurrences all number
    1
    Knee pain
         subjects affected / exposed [18]
    1 / 1 (100.00%)
         occurrences all number
    1
    Sore foot
         subjects affected / exposed [19]
    1 / 1 (100.00%)
         occurrences all number
    1
    Arm pain
         subjects affected / exposed [20]
    1 / 1 (100.00%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed [21]
    1 / 1 (100.00%)
         occurrences all number
    1
    redness in ear
         subjects affected / exposed [22]
    1 / 1 (100.00%)
         occurrences all number
    1
    Bad Tempered
         subjects affected / exposed [23]
    1 / 1 (100.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Increased hot flushes
         subjects affected / exposed [24]
    1 / 1 (100.00%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed [25]
    5 / 5 (100.00%)
         occurrences all number
    5
    Increased bleeding
         subjects affected / exposed [26]
    1 / 1 (100.00%)
         occurrences all number
    1
    Vasovagul
         subjects affected / exposed [27]
    1 / 3 (33.33%)
         occurrences all number
    3
    Immune system disorders
    Common Cold
         subjects affected / exposed [28]
    8 / 8 (100.00%)
         occurrences all number
    8
    Cold sore
         subjects affected / exposed [29]
    1 / 1 (100.00%)
         occurrences all number
    1
    Viral illness
         subjects affected / exposed [30]
    1 / 1 (100.00%)
         occurrences all number
    1
    sore throat
         subjects affected / exposed [31]
    1 / 1 (100.00%)
         occurrences all number
    1
    Eye disorders
    Blood shot eye
         subjects affected / exposed [32]
    1 / 1 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed [33]
    3 / 3 (100.00%)
         occurrences all number
    3
    Dyspepsia
         subjects affected / exposed [34]
    4 / 4 (100.00%)
         occurrences all number
    4
    Phlebitis
         subjects affected / exposed [35]
    1 / 1 (100.00%)
         occurrences all number
    1
    Stomach upset
         subjects affected / exposed [36]
    1 / 1 (100.00%)
         occurrences all number
    1
    Diverticulitis
         subjects affected / exposed [37]
    1 / 1 (100.00%)
         occurrences all number
    1
    acid reflux
         subjects affected / exposed [38]
    1 / 1 (100.00%)
         occurrences all number
    1
    Diarrhoea and vomiting
         subjects affected / exposed [39]
    1 / 1 (100.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed [40]
    1 / 1 (100.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [41]
    2 / 2 (100.00%)
         occurrences all number
    2
    Worsening of COPD
         subjects affected / exposed [42]
    1 / 1 (100.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Itchy skin
         subjects affected / exposed [43]
    2 / 2 (100.00%)
         occurrences all number
    2
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed [44]
    1 / 1 (100.00%)
         occurrences all number
    1
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed [45]
    1 / 1 (100.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Increased arthritis pain
         subjects affected / exposed [46]
    1 / 1 (100.00%)
         occurrences all number
    1
    Infections and infestations
    Anus infection
         subjects affected / exposed [47]
    1 / 1 (100.00%)
         occurrences all number
    1
    Chest infection
         subjects affected / exposed [48]
    4 / 4 (100.00%)
         occurrences all number
    4
    Infection
         subjects affected / exposed [49]
    2 / 2 (100.00%)
         occurrences all number
    2
    Infected bursitis
         subjects affected / exposed [50]
    1 / 1 (100.00%)
         occurrences all number
    1
    Notes
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.
    [50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Figures added are accurate to the event.

    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.
    The main limitation of the present study was that patients received clopidogrel for only 1 month, so chronic changes may have been missed.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24211510
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