Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

• Status: Not yet recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Ministry for Health and Solidarity, France
• Treatments: Clopidogrel

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.

• 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.

• Pregnant or breastfeeding women.

• Women of childbearing age refusing effective contraception method during the study.

• Incompetent adults (i.e. Individuals under the protection of a conservator)