Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Scleroderma, Systemic Sclerosis

In brief

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.

Key facts

Study ID

NCT05098704

Run by

University Hospital, Bordeaux

People needed

90

Starts

2022-06-22

Expected to finish

2032-06-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• CH de la Cote Basque - service de rhumatologie — Bayonne, France (enrolling)
• CH de Mont-de-Marsan - service de rhumatologie — Mont-de-Marsan, France (enrolling)
• AP-HP - Hôpital Cochin - service de médecine interne — Paris, France (enrolling)
• CH de Pau - service de médecine interne — Pau, France (enrolling)
• CHU de Bordeaux - service de rhumatologie — Bordeaux, France (enrolling)
• CHU de Brest - service de rhumatologie — Brest, France (enrolling)
• CHU de Grenoble Alpes - service de médecine vasculaire — Grenoble, France (enrolling)
• CH de Libourne - service de rhumatologie — Libourne, France (enrolling)
• CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses — Bordeaux, France
• CHU de Toulouse - service de médecine interne — Toulouse, France
• Service de Médecine Interne et Immunologie Clinique — Rennes, France

Full record on ClinicalTrials.gov

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