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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 - PSSIT

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511005-39-00
Acronym
CHUBX 2017/45
Enrollment
90
Registered
2024-02-15
Start date
2022-06-22
Completion date
Unknown
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Raynaud phenomenon

Brief summary

Occurrence of SSc at 5 years according to ACR / EULAR 2013 criteria in the two randomization groups

Detailed description

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

Interventions

DRUGPL1
DRUGPlavix 75 mg film-coated tablets

Sponsors

Centre Hospitalier Universitaire De Bordeaux
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of SSc at 5 years according to ACR / EULAR 2013 criteria in the two randomization groups—

Secondary

MeasureTime frame
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—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026