Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Hospital, Bordeaux
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- clopidogrel treatment
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Bordeaux
Lead sponsor
Ministry for Health and Solidarity, France
Collaborator
Source ClinicalTrials.gov