Clopidogrel to prevent systemic sclerosis development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the preventive effect of clopidogrel, an anti-platelet medication, on the development of systemic sclerosis (SSc) in individuals showing early signs of the disease, such as Raynaud phenomenon and specific autoantibodies. Participants will receive either clopidogrel or a placebo for two years, followed by a 36-month follow-up period to monitor disease progression and treatment effects. The study aims to determine if early intervention can halt or slow the progression of SSc by targeting platelet activation, which is believed to play a significant role in the disease's pathogenesis.

Why it matters

Who can join: the full rules

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)

Where it's running

• CH de la Cote Basque - service de rhumatologie
  Bayonne, France Recruiting
• CHU de Bordeaux - service de rhumatologie
  Bordeaux, France Recruiting
• CHU de Brest - service de rhumatologie
  Brest, France Recruiting
• CHU de Grenoble Alpes - service de médecine vasculaire
  Grenoble, France Recruiting
• CH de Libourne - service de rhumatologie
  Libourne, France Recruiting
• CH de Mont-de-Marsan - service de rhumatologie
  Mont-de-Marsan, France Recruiting

Study contacts

• Principal investigator: Marie-Elise TRUCHETET, Prof — University Hospital, Bordeaux
• Study coordinator: Marie-Elise TRUCHETET, Prof
• Email: marie-elise.truchetet@chu-bordeaux.fr
• Phone: 05.56.79.55.56

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.