Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Last updated: November 7, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

2/3

Condition

Scleroderma

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

clopidogrel treatment

Placebo

Clinical Study ID

NCT05098704
CHUBX 2017/45
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-Scl70or anti-centromere or anti-RNApolIII, or any other auto-antibodies related tosystemic 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

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 studytreatment (24 months).

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

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: clopidogrel treatment
Phase: 2/3
Study Start date:
June 22, 2022
Estimated Completion Date:
June 30, 2030

Study Description

In this study, platelet activation is targeted as it could play a key role in the pathogenesis of SSc. It has been shown in several publications that platelets are activated in SSc with a correlation between the level of activation and disease activity. Secondary to this activation, soluble and membrane effectors were increased, and induced vascular damages and fibrosis. The results obtained in the laboratory (CNRS UMR-5164) directly involved platelets in this mechanism by inducing the thymic stromal lymphopoietin (TSLP) production by endothelial cells and by showing the pro-fibrotic effect of TSLP. In vivo data in SSc murine model recently obtained, confirmed the preventive role on fibrosis of clopidogrel. The early control of this platelet activation could prevent the course of events leading to SSc.

The therapeutic strategy assessed in this study will be the oral administration of clopidogrel (75 mg per day) during two years to subjects presenting an association of specific dysimmunity and Raynaud phenomenon (RP). The administration of clopidogrel will be double-blinded versus placebo.

Subjects will be included and treated during a 2-year period and will be followed for a period of 36 months after treatment, i.e. a total of 60 months. The follow-up will be every six months mainly comprising clinical examination, patient reported outcomes and blood sampling.

Connect with a study center

  • CH de la Cote Basque - service de rhumatologie

    Bayonne,
    France

    Site Not Available

  • CHU de Bordeaux - service de rhumatologie

    Bordeaux,
    France

    Active - Recruiting

  • CHU de Brest - service de rhumatologie

    Brest,
    France

    Active - Recruiting

  • CHU de Grenoble Alpes - service de médecine vasculaire

    Grenoble,
    France

    Site Not Available

  • CH de Libourne - service de rhumatologie

    Libourne,
    France

    Site Not Available

  • CHU de Limoges - Service de médecine interne

    Limoges,
    France

    Site Not Available

  • CH de Mont-de-Marsan - service de rhumatologie

    Mont-de-Marsan,
    France

    Active - Recruiting

  • CHU de Montpellier - service de médecine vasculaire

    Montpellier,
    France

    Site Not Available

  • AP-HP - Hôpital Cochin - service de médecine interne

    Paris,
    France

    Active - Recruiting

  • CH de Pau - service de médecine interne

    Pau,
    France

    Site Not Available

  • CHU de Toulouse - service de médecine interne

    Toulouse,
    France

    Site Not Available

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