Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Oct 15, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medication called clopidogrel can help prevent the development of systemic sclerosis (SSc) in people who show early signs of the disease. Systemic sclerosis is a serious autoimmune condition that affects the skin and internal organs, and currently, there is no cure for it. The study aims to find out if giving clopidogrel to individuals with certain autoantibodies and symptoms, like Raynaud's phenomenon (which causes fingers and toes to feel numb or cold), can lower the risk of developing full-blown systemic sclerosis over time.

To participate in this trial, you need to be between 18 and 85 years old, have specific autoantibodies linked to systemic sclerosis, and report having Raynaud's phenomenon that your doctor can confirm. However, if you already have a diagnosis of systemic sclerosis or are currently taking certain medications like blood thinners or immunosuppressants, you won't be eligible to join. If you take part, you will be monitored closely for two years to see how your body responds to the treatment. This study is important because it could lead to new ways to prevent a challenging condition that affects many people.

Gender

ALL

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)