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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Phase II/III Double-blind Randomized Placebo-controlled Trial Assessing the Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk in Subjects With Specific Dysimmunity and Raynaud Phenomenon

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

clopidogrel treatment

75 mg daily during 24 months

DRUG

Placebo

75 mg daily during 24 months

Locations (10)

CH de la Cote Basque - service de rhumatologie
Bayonne, France
CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses
Bordeaux, France
CHU de Bordeaux - service de rhumatologie
Bordeaux, France
CHU de Brest - service de rhumatologie
Brest, France
CHU de Grenoble Alpes - service de médecine vasculaire
Grenoble, France
CH de Libourne - service de rhumatologie
Libourne, France
CH de Mont-de-Marsan - service de rhumatologie
Mont-de-Marsan, France
AP-HP - Hôpital Cochin - service de médecine interne
Paris, France
CH de Pau - service de médecine interne
Pau, France
CHU de Toulouse - service de médecine interne
Toulouse, France