Study Testing Clopidogrel to Prevent Systemic Sclerosis in Adults with Specific Autoantibodies and Raynaud Phenomenon

What this Trial Is About

Researchers are investigating the preventive effect of clopidogrel on the development of systemic sclerosis SSc, a severe autoimmune disease involving immune dysfunction, blood vessel damage, and tissue scarring. The study focuses on people with Raynaud phenomenon and specific SSc-related autoantibodies, who are at risk of developing full systemic sclerosis. This Phase IIIII trial aims to assess whether early platelet activation control can reduce disease progression. Participants will be randomly assigned to receive either clopidogrel 75 mg daily or a placebo for two years in a double-blind manner. The study will include a 24-month treatment period followed by a 36-month follow-up, totaling five years. Clopidogrel targets platelet activation, which lab and animal studies suggest plays a key role in SSc-related fibrosis. Throughout the study, participants will have clinical exams, blood tests, and patient-reported outcome assessments every six months. Researchers will measure the frequency of SSc development after five years according to established criteria, along with skin fibrosis, hand function, and antibody presence. The trial also monitors disease features and safety over the entire 60-month period.

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk