A Phase 2/3 interventional study of clopidogrel treatment and Placebo in Scleroderma and Systemic Sclerosis, sponsored by University Hospital, Bordeaux. Recruiting at 11 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University Hospital, Bordeaux · Phase 2/3, Interventional, and Treatment
Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.
In this study, platelet activation is targeted as it could play a key role in the pathogenesis of SSc. It has been shown in several publications that platelets are activated in SSc with a correlation between the level of activation and disease activity. Secondary to this activation, soluble and membrane effectors were increased, and induced vascular damages and fibrosis. The results obtained in the laboratory (CNRS UMR-5164) directly involved platelets in this mechanism by inducing the thymic stromal lymphopoietin (TSLP) production by endothelial cells and by showing the pro-fibrotic effect of TSLP. In vivo data in SSc murine model recently obtained, confirmed the preventive role on fibrosis of clopidogrel. The early control of this platelet activation could prevent the course of events leading to SSc.
The therapeutic strategy assessed in this study will be the oral administration of clopidogrel (75 mg per day) during two years to subjects presenting an association of specific dysimmunity and Raynaud phenomenon (RP). The administration of clopidogrel will be double-blinded versus placebo.
Subjects will be included and treated during a 2-year period and will be followed for a period of 36 months after treatment, i.e. a total of 60 months. The follow-up will be every six months mainly comprising clinical examination, patient reported outcomes and blood sampling.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's planned enrollment of 90 is above the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: clopidogrel treatment
Drug: Placebo
75 mg daily during 24 months
75 mg daily during 24 months
Frequency of occurrence of SSc at 5 years according to American College of Rheumatology (ACR) / European League Against Rhumatism (EULAR) 2013 criteria in the two randomization groups
Time frame: 60 months after baseline (Day 0)
Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups
Time frame: 60 months after baseline (Day 0)
Mean of modified Rodnan skin score (which varies between 0 and 51, with higher values mean higher disease severity) in the two randomization groups.
Time frame: 60 months after baseline (Day 0)
Mean of Cochin hand function scale (which varies between 0 and 90, with higher values mean higher disease severity) in the two randomization groups.
Time frame: 60 months after baseline (Day 0)
Proportion of sex ratio at inclusion in the two randomization groups.
Time frame: At baseline (Day 0)
Mean age at inclusion in the two randomization groups.
Time frame: At baseline (Day 0)
Proportion of patients exposed to toxic products at inclusion in the two randomization groups.
Time frame: At baseline (Day 0)
Proportion of patients exposed to toxic products at 5 years in the two randomization groups.
Time frame: 60 months after baseline (Day 0)
Proportion of patients affected by a limited form of SSc at 5 years in the two randomization groups.
Time frame: 60 months after baseline (Day 0)
Proportion of patients affected by a diffuse form of SSc at 5 years in the two randomization groups.
Time frame: 60 months after baseline (Day 0)
Proportion of patients presenting a specific antibody positivity (anti-scl70, anti-centromere) in the two randomization groups at inclusion.
Time frame: At baseline (Day 0)
Proportion of patients presenting megacapillaries by capillaroscopy at 5 years in the two randomization groups.
Time frame: 60 months after baseline (Day 0)
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