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    Clinical Trial Results:
    Risk of apoplexia cerebri in clopidogrel non-responders.

    Summary
    EudraCT number
    2011-004748-23
    Trial protocol
    DK  
    Global end of trial date
    11 Nov 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jul 2018
    First version publication date
    13 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2011080362
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02093299
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Sygehusvej 10, Roskilde, Denmark, 4000
    Public contact
    Neurologisk ambulatorium, Neurologisk Afdeling, 0045 47322800, clra@regionsjaelland.dk
    Scientific contact
    Neurologisk ambulatorium, Neurologisk Afdeling, 0045 47322800, clra@regionsjaelland.dk
    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
    22 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Assesment of risk og apoplexia cerebri in clopidogrel non-responders
    Protection of trial subjects
    All patients were offered quick access by telephone to the study physician should any concerns about treatment occur.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Jan 2012
    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: 165
    Worldwide total number of subjects
    165
    EEA total number of subjects
    165
    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)
    63
    From 65 to 84 years
    102
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects recruited from the stroke unit at the Neurovascular center between December 2012 and November 2016.

    Pre-assignment
    Screening details
    179 subjects were screened for inclusion. Inclusion criteria: age 18 and 90 years, acute ischemic stroke, treatment with clopidogrel 75 mg/day. Exclusion criteria: treatment with other platelet inhibitor than clopidogrel, previous stroke, known cancer, increased bleeding risk.

    Pre-assignment period milestones
    Number of subjects started
    179 [1]
    Number of subjects completed
    165

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Physician decision: 14
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 179 patients were screened and 165 included
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Both subject and investigator were blinded for the Platelet Raction Unit (PRU)-result during the follow-up period. Blood samples were collected by the investigator, but analysis was performed by the study-nurse who had no contact with the subjects. The investigator did not have access to PRU-results.

    Arms
    Arm title
    all patients
    Arm description
    only one arm. Experimental.
    Arm type
    Experimental

    Investigational medicinal product name
    clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    75 mg/day

    Number of subjects in period 1
    all patients
    Started
    165
    Completed
    142
    Not completed
    23
         Adverse event, non-fatal
    19
         Protocol deviation
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    165 165
    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)
    63 63
        From 65-84 years
    102 102
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    55 55
        Male
    110 110

    End points

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    End points reporting groups
    Reporting group title
    all patients
    Reporting group description
    only one arm. Experimental.

    Primary: Composite vascular event

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    End point title
    Composite vascular event [1]
    End point description
    Composite end point of stroke, acute myocardial infarction or vascular death
    End point type
    Primary
    End point timeframe
    froim inclusion and through 24 months follow-up
    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: Too few patients in the HTPR- group to make statistical analysis. Underpowered study
    End point values
    Number of subjects analysed
    Units: Events
    No statistical analyses for this end point

    Primary: Platelet Reaction Units

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    End point title
    Platelet Reaction Units [2]
    End point description
    Platelet Reaction Units are dichotomized at PRU=208 to define subjects with high on treatment platelet reactivity ( or non-responders) (PRU>208)
    End point type
    Primary
    End point timeframe
    Platelet Reaction Units measured once during follow-up (preferrable at inclusion visit)
    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: As there is only 1 group, the form cannot be filled.
    End point values
    Number of subjects analysed
    Units: PRU
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion and through 24 months follow-up
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    SNOMED CT
    Dictionary version
    2011
    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
    18 / 165 (10.91%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases to liver
         subjects affected / exposed
    2 / 165 (1.21%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Aneurysm repair
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transurethral incision of prostate
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileostomy closure
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Atrial fibrillation
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    3 / 165 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Transient ischaemic attack
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Angioedema
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Hip fracture
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 165 (1.21%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 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
    6 / 165 (3.64%)
    Investigations
    Fatigue
         subjects affected / exposed
    4 / 165 (2.42%)
         occurrences all number
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    1 / 165 (0.61%)
         occurrences all number
    1

    More information

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    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
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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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