Raynaud phenomenon MedDRA version: 20.0 Level: LLT Classification code 10037914 Term: Raynaud's syndrome System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Plavix
Product Name: CLOPIDOGREL
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion 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. - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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. - Pregnant or breastfeeding women. - Women of childbearing age refusing effective contraception method during the study. - Incompetent adults (i.e. Individuals under the protection of a conservator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the onset of a SSc after 5 years in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.;Secondary Objective: - To compare after 2 and 5 years the onset of a skin fibrosis in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo. - To compare after 2 and 5 years the extent of skin fibrosis in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo. - To compare after 2 and 5 years the risk of degradation of the Cochin Hand Function Scale in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo. - Assessment of clinical, demographic, biologic or capillaroscopic prognosis factors associated with a higher risk to develop an SSc when presenting with specific dysimmunity and RP.;Primary end point(s): Occurrence of SSc at 5 years according to ACR / EULAR 2013 criteria in the two randomization groups;Timepoint(s) of evaluation of this end point: 60 months after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups - Mean of modified Rodman skin score in the two randomization groups - Mean of Cochin Hand Function Scale in the two randomization groups - Demographic (sex, age, environmental factors), clinical (associated diseases, history), biological, capillaroscopic criteria in the two randomization groups ;Timepoint(s) of evaluation of this end point: 60 months after baseline | — |
Countries
France
Contacts
Public ContactREC - Laetitia LACAZE-BUZY
CHU de Bordeaux
Outcome results
None listed