Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 85Years
All Genders
NCT05098704

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Led by University Hospital, Bordeaux · Updated on 2025-07-14

90

Participants Needed

10

Research Sites

466 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Bordeaux

Lead Sponsor

M

Ministry for Health and Solidarity, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years old and under 85 years old
  • Positive anti-nuclear antibodies (AAN ≥ 1/160) specific to systemic sclerosis such as anti-Scl70, anti-centromere, or anti-RNA polymerase III
  • Presence of Raynaud phenomenon confirmed by a physician
  • Affiliated with a health insurance system
  • Willingness to participate and signed informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of systemic sclerosis according to ACR/EULAR 2013 criteria
  • Presence of skin fibrosis at screening
  • Current antiplatelet treatment
  • Contraindications to clopidogrel
  • Use of immunosuppressive agents at screening
  • Use of anticoagulant treatment at screening
  • Pregnant or breastfeeding women
  • Women of childbearing age not using effective contraception during the 24-month treatment
  • Adults under legal protection (incompetent adults)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

CH de la Cote Basque - service de rhumatologie

Bayonne, France

Actively Recruiting

2

CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses

Bordeaux, France

Not Yet Recruiting

3

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

Actively Recruiting

4

CHU de Brest - service de rhumatologie

Brest, France

Actively Recruiting

5

CHU de Grenoble Alpes - service de médecine vasculaire

Grenoble, France

Not Yet Recruiting

6

CH de Libourne - service de rhumatologie

Libourne, France

Actively Recruiting

7

CH de Mont-de-Marsan - service de rhumatologie

Mont-de-Marsan, France

Actively Recruiting

8

AP-HP - Hôpital Cochin - service de médecine interne

Paris, France

Actively Recruiting

9

CH de Pau - service de médecine interne

Pau, France

Actively Recruiting

10

CHU de Toulouse - service de médecine interne

Toulouse, France

Not Yet Recruiting

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Research Team

M

Marie-Elise TRUCHETET, Prof

CONTACT

T

Thomas BARNETCHE, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk | DecenTrialz