Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Hospital, Bordeaux
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
clopidogrel treatment
Drug75 mg daily during 24 months
Placebo
Drug75 mg daily during 24 months
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: clopidogrelExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of occurrence of SSc at 5 years according to American College of Rheumatology (ACR) / European League Against Rhumatism (EULAR) 2013 criteria in the two randomization groups
Time frame
60 months after baseline (Day 0)Secondary outcomes
1
Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups
Time frame
60 months after baseline (Day 0)2
Mean of modified Rodnan skin score (which varies between 0 and 51, with higher values mean higher disease severity) in the two randomization groups.
Time frame
60 months after baseline (Day 0)3
Mean of Cochin hand function scale (which varies between 0 and 90, with higher values mean higher disease severity) in the two randomization groups.
Time frame
60 months after baseline (Day 0)4
Proportion of sex ratio at inclusion in the two randomization groups.
Time frame
At baseline (Day 0)Sponsors and contacts
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University Hospital, Bordeaux
Lead sponsor
Ministry for Health and Solidarity, France
Collaborator
Source ClinicalTrials.gov