Status:

RECRUITING

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Lead Sponsor:

University Hospital, Bordeaux

Collaborating Sponsors:

Ministry for Health and Solidarity, France

Conditions:

Scleroderma

Systemic Sclerosis

Eligibility:

All Genders

18-85 years

Phase:

PHASE2

PHASE3

Brief 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...

Detailed 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 ...

Eligibility 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, 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)

Key Trial Info

Start Date :

June 22 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2031

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT05098704

Start Date

June 22 2022

End Date

June 1 2031

Last Update

July 14 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

CH de la Cote Basque - service de rhumatologie

Bayonne, France

2

CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses

Bordeaux, France

3

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

4

CHU de Brest - service de rhumatologie

Brest, France