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    Clinical Trial Results:
    Pilot Study related to the effect of clopidogrel on plasmatic soluble CD40 ligand during systemic lupus erythematous

    Summary
    EudraCT number
    		 2014-003733-25
    Trial protocol
    		 FR  
    Global end of trial date
    11 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2026
    First version publication date
    18 Sep 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUBX 2013/27
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02320357
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Bordeaux
    Sponsor organisation address
    12, rue Dubernat, TALENCE, France, 33404 cedex
    Public contact
    Laetitia LACAZE-BUZY, CHU de BORDEAUX, 33 557821134, laetitia.lacaze-buzy@chu-bordeaux.fr
    Scientific contact
    Laetitia LACAZE-BUZY, CHU de BORDEAUX, 33 557821134, laetitia.lacaze-buzy@chu-bordeaux.fr
    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
    15 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Clopidogrel is an anti-platelet aggregation agent that exposes the risk of bleeding. Thus, any situation at risk of bleeding at inclusion or during the study will imply a non-inclusion or an adaptation of the protocol.
    Protection of trial subjects
    Clopidogrel is an anti-platelet aggregation agent that exposes the risk of bleeding. Thus, any situation at risk of bleeding at inclusion or during the study will imply a non-inclusion or an adaptation of the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    15
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of inclusion of first patient: 19-AUG-2015 Date of last visit last patient: 11-SEP-2017 3 centers in France participated in the study

    Pre-assignment
    Screening details
    		 -Patients 18 years of age and older -Diagnosis of SLE according to revised criteria of American College of Rhumatology -Being affiliated to health insurance -Having signed an informed consent

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

    Arms
    Arm title
    		 Clopidogrel
    Arm description
    		 -
    Arm type
    		 Single arm study

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally at the dosage of one 75 mg tablet per day.

    Number of subjects in period 1
    		Clopidogrel
    Started
    18
    Completed
    18
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Clopidogrel
    Arm description
    		 Patients receiving clopidogrel over a 12 week period
    Arm type
    		 Single arm study

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally at the dosage of one 75 mg tablet per day.

    Number of subjects in period 2
    		Clopidogrel
    Started
    18
    Completed
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 18 18
    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 (standard deviation)
    		 48.8 ( 16.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Clopidogrel
    Reporting group description
    		 -
    Reporting group title
    Clopidogrel
    Reporting group description
    		 Patients receiving clopidogrel over a 12 week period

    Primary: Decrease of plasmatic sCD40L levels

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    End point title
    		 Decrease of plasmatic sCD40L levels
    End point description
    End point type
    Primary
    End point timeframe
    At 12 weeks
    End point values
    		 Clopidogrel Clopidogrel
    Number of subjects analysed
    18
    15
    Units: percent
        arithmetic mean (standard deviation)
    80.8 ( 70.7 )
    65.1 ( 39.4 )
    Statistical analysis title
    		 Soluble CD40L: mixed model analysis
    Statistical analysis description
    Slope change model at D7 and S12 with random intercept
    Comparison groups
    Clopidogrel v Clopidogrel
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3492
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Measurements of inflammation markers (CRP)

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    End point title
    		 Measurements of inflammation markers (CRP)
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Clopidogrel
    Number of subjects analysed
    16
    Units: milligram(s)/litre
        arithmetic mean (standard deviation)
    3.3 ( 3.9 )
    No statistical analyses for this end point

    Secondary: Platelet activation markers - Platelet volume

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    End point title
    		 Platelet activation markers - Platelet volume
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Clopidogrel
    Number of subjects analysed
    15
    Units: fluid ounce
        arithmetic mean (standard deviation)
    8.3 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Platelet/circulating mononuclear cells aggregates - Aggregates CD3+ platelets

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    End point title
    		 Platelet/circulating mononuclear cells aggregates - Aggregates CD3+ platelets
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Clopidogrel Clopidogrel
    Number of subjects analysed
    18
    15
    Units: percent
        arithmetic mean (standard deviation)
    28.2 ( 8.4 )
    27.2 ( 9.4 )
    Statistical analysis title
    		 Agreg evolution CD3+ platelets
    Statistical analysis description
    Slope change model at D0 and S12 with random intercept
    Comparison groups
    Clopidogrel v Clopidogrel
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9362
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: T lymphocytes activation

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    End point title
    		 T lymphocytes activation
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Clopidogrel
    Number of subjects analysed
    16
    Units: percent
        arithmetic mean (standard deviation)
    23.3 ( 10.7 )
    No statistical analyses for this end point

    Secondary: Measurements of complement protein - C3 weight assay

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    End point title
    		 Measurements of complement protein - C3 weight assay
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Clopidogrel
    Number of subjects analysed
    16
    Units: gram(s)/litre
        arithmetic mean (standard deviation)
    1.0 ( 0.2 )
    No statistical analyses for this end point

    Secondary: Measurements of complement protein - C4 weight assay

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    End point title
    		 Measurements of complement protein - C4 weight assay
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Clopidogrel
    Number of subjects analysed
    16
    Units: gram(s)/litre
        arithmetic mean (standard deviation)
    0.2 ( 0.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Adverse event reporting additional description
    These adverse events are described by Preferred Terms (PT).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Clopidogrel
    Reporting group description
    		 -

    Serious adverse events
    		 Clopidogrel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 18 (11.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Reproductive system and breast disorders
    Menorrhagia (10027313)
    Additional description: Menorrhagia (10027313)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Respiratory tract infection viral (10062106)
    Additional description: Respiratory tract infection viral (10062106)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Clopidogrel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 18 (94.44%)
    Vascular disorders
    Haematoma (10018852)
    Additional description: Haematoma (10018852)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Varicose vein (10046996)
    Additional description: Varicose vein (10046996)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Cervical dysplasia (10008263)
    Additional description: Cervical dysplasia (10008263)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Menstrual disorder (10027327)
    Additional description: Menstrual disorder (10027327)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea (10013968)
    Additional description: Dyspnoea (10013968)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Epistaxis (10015090)
    Additional description: Epistaxis (10015090)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Subcutaneous haematoma (10042345)
    Additional description: Subcutaneous haematoma (10042345)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nervous system disorders
    Headache (10019211)
    Additional description: Headache (10019211)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Epilepsy (10015037)
    Additional description: Epilepsy (10015037)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Sciatica (10039674)
    Additional description: Sciatica (10039674)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Aplasia pure red cell (10002965)
    Additional description: Aplasia pure red cell (10002965)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis allergic (10010744)
    Additional description: Conjunctivitis allergic (10010744)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Abnormal sensation in eye (10000173)
    Additional description: Abnormal sensation in eye (10000173)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dyspepsia (10013946)
    Additional description: Dyspepsia (10013946)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Functional gastrointestinal disorder (10071275)
    Additional description: Functional gastrointestinal disorder (10071275)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Toothache (10044055)
    Additional description: Toothache (10044055)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Eczema (10014184)
    Additional description: Eczema (10014184)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Ecchymosis (10014080)
    Additional description: Ecchymosis (10014080)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Erythema (10015150)
    Additional description: Erythema (10015150)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Skin haemorrhage (10064265)
    Additional description: Skin haemorrhage (10064265)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Rash (10037844)
    Additional description: Rash (10037844)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Photosensitivity reaction (10034972)
    Additional description: Photosensitivity reaction (10034972)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Renal and urinary disorders
    Pollakiuria (10036018)
    Additional description: Pollakiuria (10036018)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Urine odour abnormal (10057135)
    Additional description: Urine odour abnormal (10057135)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Endocrine disorders
    Thyroid mass (10058900)
    Additional description: Thyroid mass (10058900)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia (10003239)
    Additional description: Arthralgia (10003239)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 18 (38.89%)
         occurrences all number
    7
    Sjogren's syndrome (10040767)
    Additional description: Sjogren's syndrome (10040767)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pain in extremity (10033425)
    Additional description: Pain in extremity (10033425)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Tenosynovitis (10043261)
    Additional description: Tenosynovitis (10043261)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Tendonitis (10043255)
    Additional description: Tendonitis (10043255)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis (10006451)
    Additional description: Bronchitis (10006451)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Gastroenteritis (10017888)
    Additional description: Gastroenteritis (10017888)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Gingivitis (10018292)
    Additional description: Gingivitis (10018292)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Sinusitis (10040753)
    Additional description: Sinusitis (10040753)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Pharyngitis (10034835)
    Additional description: Pharyngitis (10034835)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nasopharyngitis (10028810)
    Additional description: Nasopharyngitis (10028810)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Tinea versicolour (10056131)
    Additional description: Tinea versicolour (10056131)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Vulvovaginal mycotic infection (10064899)
    Additional description: Vulvovaginal mycotic infection (10064899)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    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/33152483
    http://www.ncbi.nlm.nih.gov/pubmed/29635077
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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
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