systemic lupus erythematous
Conditions
Interventions
Trade Name: PLAVIX, clopidogrel, 75mg
Product Name: CLOPIDOGREL
Pharmaceutical Form: Tablet
Sponsors
CHU de BORDEAUX
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 18-65 years - Diagnosis of SLE according to revised criteria of American College of Rhumatology - Being affiliated to health insurance - Having signed an informed consent (later than the day of inclusion and before any examination required by research) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - > 20mg/day of prednisone equivalent for > 7 days 30 days before the pre-inclusion. - Diseases flare 3 months before the inclusion. A disease flare is defined by an increase of SLEDAI score >3 and or a change of the immunosuppressive treatment and or an increase of steroids dose. - Is treated or has received 3 months before the pre-inclusion steroids pulses or intravenous immunoglobulins. - Renal involvement that could required a kidney biopsy. - Required surgery in the next 12 weeks. - Has been treated by cyclophosphamide 3 months before the pre-inclusion. - Has been treated by biotherapy 6 months before the pre-inclusion. - Contraindication to clopidogrel (annex 1). - History of cancer except healed basal cell carcinoma. - History of severe hemorrhage - Disease exposing to hemorrhage - Associated antiphospholipid syndrome - Pregnant or breastfeeding women - No contraception for women of childbearing age - Severe hypertension - Ongoing statin, non-steroidal anti-inflammatory, antiplatelet and anticoagulant drugs. - Being under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Démontrer chez des patients affectés de LES que l’administration du clopidogrel pendant 12 semaines de traitement permet de diminuer les taux plasmatiques de CD40 ligand soluble.;Secondary Objective: - Evaluer la cinétique de diminution des taux plasmatiques de CD40L soluble sous clopidogrel - Evaluer les marqueurs biologiques lupiques sous clopidogrel - Evaluer l’effet du clopidogrel sur l’activation plaquettaire - Evaluer la tolérance du clopidogrel chez des patients lupiques ;Primary end point(s): Decrease of plasmatic sCD40L levels 12 weeks after inclusion;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Decrease of plasmatic sCD40L levels 24 hours, 7 days and every 4 we eks until 16 weeks after inclusion. - Measurements of inflammation markers (erythrocyte sediment rate, C reactive protein), antoantibodies levels (antinuclear antibodies, anti-double strand DNA antibodies), complement fractions (C3, C4, CH50). - Expression of IFN inducible genes by rtPCR in circulating monocytes. - Platelet activation markers (CD40L and P Selectin (CD62p)) by flow cytometry. - Platelet/circulating mononuclear cells aggregates by flow cytometry. - T lymphocytes activation (HLA-DR) by flow cytometry. - Rate of haemorrhagic side effects during the follow up.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
France
Contacts
Public ContactLaetitia LACAZE-BUZY
CHU de BORDEAUX
Outcome results
None listed