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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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