NCT05098704RecruitingPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 4 Oct 2021
- Start date
- 22 Jun 2022
- Primary completion date
- 30 Jun 2032
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05098704
- EU CT number
- 2024-511005-39-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 90
- From 22 Jun 2022 to the primary completion date, 30 Jun 2032
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Women of childbearing age refusing effective contraception method during the study treatment (24 months).
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH de la Côte Basque - service de rhumatologie Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| CHU de Bordeaux - service de rhumatologie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| CHU de Brest - Service de rhumatologie Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| CHU de Grenoble Alpes - service de médecine vasculaire Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| CH de Libourne - service de rhumatologie Coordinator of this site? Confirm its status | Libourne | France | Recruiting |
| CH de Mont-de-Marsan - service de rhumatologie Coordinator of this site? Confirm its status | Mont-de-Marsan | France | Recruiting |
| AP-HP - Hôpital Cochin - service de Médecine Interne Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CH de Pau - service de médecine interne Coordinator of this site? Confirm its status | Pau | France | Recruiting |
| Service de Médecine Interne et Immunologie Clinique Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| CHU de Toulouse - service de médecine interne Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.