Ignite Creation Date:
2024-05-06 @ 3:35 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02320357
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2014-12-16
Brief Title:
Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLOPUS
Brief Summary:
CD40 Ligand CD40L has been identified as a key feature in systemic lupus erythematosus SLE pathogenesis a systemic autoimmune disease characterized by a multiorgan involvement As platelets are a major source of soluble CD40L sCD40L we propose to study the effect of clopidogrel a platelet inhibitor on plasmatic sCD40L levels in SLE patients
Detailed Description:
Type I interferon IFN and CD40L have been identified as important in SLE pathogenesis 1 CD40L is now considered as a biomarker of lupus activity 4 Because platelets represent a major reservoir of CD40L we previously studied the role of platelet derived CD40L in SLE pathogenesis 5 We showed that platelets from SLE patients were activated in vivo by circulating immune complexes composed of autoantibodies bound to self antigens through a Fc-gamma Receptor IIa CD32-dependent mechanism Further platelet activation correlated with severity of the disease and activated platelets formed aggregates with antigen-presenting cells including monocytes and plasmacytoid dendritic cells In addition activated platelets enhanced IFN-α secretion by immune complexes-stimulated plasmacytoid dendritic cells in vitro through a CD154-CD40 interaction In lupus prone mice depletion of platelets or administration of the clopidogrel improved all measures of disease activity and overall survival In this pilot study the treatment of the research is clopidogrel given at the dose of 75mg once a day For the features of the treatment its contraindications its disruption in case of side effects cf to annex 1 Clopidogrel associated with the usual treatment of patients will be given for 12 weeks the follow up of patients will be 16 weeks all side effects occurring during this period will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None