NCT05098704 Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
| NCT ID | NCT05098704 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University Hospital, Bordeaux |
| Condition | Scleroderma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-06-22 |
| Primary Completion | 2032-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2022-06-22 with a primary completion date of 2032-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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)
Contact & Investigator
Marie-Elise TRUCHETET, Prof
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05098704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Scleroderma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05098704 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05098704 currently recruiting?
Yes, NCT05098704 is actively recruiting participants. Contact the research team at marie-elise.truchetet@chu-bordeaux.fr for enrollment information.
Where is the NCT05098704 trial being conducted?
This trial is being conducted at Bayonne, France, Bordeaux, France, Bordeaux, France, Brest, France and 7 additional locations.
Who is sponsoring the NCT05098704 clinical trial?
NCT05098704 is sponsored by University Hospital, Bordeaux. The principal investigator is Marie-Elise TRUCHETET, Prof at University Hospital, Bordeaux. The trial plans to enroll 90 participants.