Clopidogrel to prevent systemic sclerosis development
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
PHASE2; PHASE3 · University Hospital, Bordeaux · NCT05098704
This study tests if taking clopidogrel can help prevent systemic sclerosis from developing in people who have early signs of the disease.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 10 sites (Bayonne and 9 other locations) |
| Trial ID | NCT05098704 on ClinicalTrials.gov |
What this trial studies
This study investigates the preventive effect of clopidogrel, an anti-platelet medication, on the development of systemic sclerosis (SSc) in individuals showing early signs of the disease, such as Raynaud phenomenon and specific autoantibodies. Participants will receive either clopidogrel or a placebo for two years, followed by a 36-month follow-up period to monitor disease progression and treatment effects. The study aims to determine if early intervention can halt or slow the progression of SSc by targeting platelet activation, which is believed to play a significant role in the disease's pathogenesis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with positive autoantibodies related to systemic sclerosis and a history of Raynaud phenomenon.
Not a fit: Patients already diagnosed with systemic sclerosis or those with contraindications to clopidogrel will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing systemic sclerosis in at-risk individuals.
How similar studies have performed: Previous studies have indicated a potential role of platelet activation in systemic sclerosis, but this specific preventive approach using clopidogrel is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bayonne and 9 other locations
- CH de la Cote Basque - service de rhumatologie — Bayonne, France (RECRUITING)
- CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses — Bordeaux, France (NOT_YET_RECRUITING)
- CHU de Bordeaux - service de rhumatologie — Bordeaux, France (RECRUITING)
- CHU de Brest - service de rhumatologie — Brest, France (RECRUITING)
- CHU de Grenoble Alpes - service de médecine vasculaire — Grenoble, France (NOT_YET_RECRUITING)
- CH de Libourne - service de rhumatologie — Libourne, France (RECRUITING)
- CH de Mont-de-Marsan - service de rhumatologie — Mont-de-Marsan, France (RECRUITING)
- AP-HP - Hôpital Cochin - service de médecine interne — Paris, France (RECRUITING)
- CH de Pau - service de médecine interne — Pau, France (RECRUITING)
- CHU de Toulouse - service de médecine interne — Toulouse, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Marie-Elise TRUCHETET, Prof — University Hospital, Bordeaux
- Study coordinator: Marie-Elise TRUCHETET, Prof
- Email: marie-elise.truchetet@chu-bordeaux.fr
- Phone: 05.56.79.55.56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scleroderma, Systemic Sclerosis, systemic sclerosis, clopidogrel, platelet, prevention, primary care