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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    CLOpidogrel response and CYP2C19 Genotype in Ischemic Stroke patients

    Summary
    EudraCT number
    		 2015-003548-38
    Trial protocol
    		 DK  
    Global end of trial date
    17 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Dec 2020
    First version publication date
    12 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2015-1CR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Sygehusvej 10, Roskilde, Denmark, 4000
    Public contact
    Neurologisk Afdeling, Roskilde Syge, Neurologisk Afdeling, Roskilde Sygehus, +45 47322800,
    Scientific contact
    Neurologisk Afdeling, Roskilde Syge, Neurologisk Afdeling, Roskilde Sygehus, +45 47322800,
    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
    17 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Is there a connection between single nucleotide polymorphisms of liver enzyme CYP2C19 and the high on treatment platelet reactivity (HOTPR) when treating with Clopidogrel (Clopidogrel-respons) in different doses.
    Protection of trial subjects
    No specific measures. Patients delivered a blood sample.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 May 2016
    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
    Denmark: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    37
    From 65 to 84 years
    62
    85 years and over
    4

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 All adults over the age of 18 with a diagnosis of ischemic stroke and treated with clopidogrel once daily were recruited after informed verbal and written signed consent.

    Pre-assignment
    Screening details
    		 All patient with a diagnosis of ischemic stroke were screened by a physician

    Period 1
    Period 1 title
    Overall trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Study population
    Arm description
    		 All patients in the trail. All had clopidogrel as a standard of care and all had a blood sample.
    Arm type
    		 Experimental

    Investigational medicinal product name
    clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg orally once daily

    Number of subjects in period 1
    		Study population
    Started
    103
    Completed
    103
    Period 2
    Period 2 title
    trial
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 genotype
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		genotype
    Started
    103
    Completed
    103

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 103 103
    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)
    		 37 37
        From 65-84 years
    		 62 62
        85 years and over
    		 4 4
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 62 62

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Study population
    Reporting group description
    		 All patients in the trail. All had clopidogrel as a standard of care and all had a blood sample.
    Reporting group title
    genotype
    Reporting group description
    		 -

    Primary: responder and genotype

    		 Close Top of page
    End point title
    		 responder and genotype
    End point description
    End point type
    Primary
    End point timeframe
    Instantly after bloodsampling using POC-device
    End point values
    		 Study population genotype
    Number of subjects analysed
    103
    103 [1]
    Units: 2
        responder
    103
    0
        nonresponder
    0
    0
        carrier
    0
    31
        non-carrier
    0
    70
    Notes
    [1] - 101
    Statistical analysis title
    		 responder and CYP2C19 carrier
    Comparison groups
    Study population v genotype
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    From inklusion to last blood sampling
    Adverse event reporting additional description
    The were np seroius og non-serious adverse events. This was because there were no non-responders to 75 mg clopidogrel once daily and therefore no subject were followed in the study. There was no intervention
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
    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: Alle forsøgsdetalgere var respondere på clopidogrel 75 mg dagligt. Derfor blev alle forsøgsdeltagere afsluttet ved første besøg. Der var ingen intervention, ingen forsøgsdeltagere blev fulgt og derfor ingen adverse events.

    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
    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-Sun Apr 28 01:56:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA