Testing clopidogrel to prevent systemic sclerosis in people with Raynaud phenomenon
Tests whether clopidogrel, compared with placebo, prevents systemic sclerosis in adults with Raynaud phenomenon.
Plain-language title generated from the registry record
Registry title: Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Key facts
- Where
- Bayonne, Bordeaux, Brest, Grenoble, Libourne, Mont-de-Marsan, Paris, Pau, Rennes, and Toulouse, FranceSee the 11 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05098704, who can take part
Where in France
- CH de la Côte Basque - service de rhumatologieBayonne, FranceTaking people
- CHU de Bordeaux - service de Médecine Interne et Maladies InfectieusesBordeaux, FranceNot yet recruiting
- CHU de Bordeaux - service de rhumatologieBordeaux, FranceTaking people
- CHU de Brest - Service de rhumatologieBrest, FranceTaking people
- CHU de Grenoble Alpes - service de médecine vasculaireGrenoble, FranceTaking people
- CH de Libourne - service de rhumatologieLibourne, FranceTaking people
- CH de Mont-de-Marsan - service de rhumatologieMont-de-Marsan, FranceTaking people
- AP-HP - Hôpital Cochin - service de Médecine InterneParis, FranceTaking people
- CH de Pau - service de médecine internePau, FranceTaking people
- Service de Médecine Interne et Immunologie CliniqueRennes, FranceNot yet recruiting
- CHU de Toulouse - service de médecine interneToulouse, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Bordeaux
- Trial code
- NCT05098704EU 2024-511005-39-00
- Record updated
- 7 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Women of childbearing age refusing effective contraception method during the study treatment (24 months); 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; Incompetent adults (i.e. Individuals under the protection of a conservator).