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Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

RecruitingPhase 2, Phase 3

Sponsor: University Hospital, Bordeaux

Conditions: Scleroderma, Systemic Sclerosis

Interventions: clopidogrel treatment, Placebo

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patient over 18 years old, and less than 85 years old.
* Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere or anti-RNApolIII, or any other auto-antibodies related to systemic sclerosis
* Patient with RP reported by the subject and confirmed by the physician.
* Patient affiliated to a health insurance system.
* Patient who accepts to participate to the study and signs an inform consent form.

Exclusion Criteria:

* Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.
* Patient with skin fibrosis at screening.
* Patient with antiplatelet treatment at screening.
* Patient with contraindications to clopidogrel.
* Patient treated by immunosuppressive agent at screening.
* Patient treated by anticoagulants at screening
* Pregnant or breastfeeding women.
* Women of childbearing age refusing effective contraception method during the study treatment (24 months).
* Incompetent adults (i.e. Individuals under the protection of a conservator)

Locations (11)

Bayonne, France
Bordeaux, France
Bordeaux, France
Brest, France
Grenoble, France
Libourne, France
Mont-de-Marsan, France
Paris, France
Pau, France
Rennes, France
Toulouse, France