Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

NCT05098704 | Recruiting Phase 2

• 1 other identifier: CHUBX 2017/45
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

Brief Summary

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

Scleroderma; Systemic Sclerosis

Keywords

systemic sclerosis; clopidogrel; platelet; prevention; primary care

Outcome Measures

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

  60 months after baseline (Day 0)

Secondary Outcomes (11)

• Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups

  60 months after baseline (Day 0)

• Mean of modified Rodnan skin score (which varies between 0 and 51, with higher values mean higher disease severity) in the two randomization groups.

  60 months after baseline (Day 0)

• Mean of Cochin hand function scale (which varies between 0 and 90, with higher values mean higher disease severity) in the two randomization groups.

  60 months after baseline (Day 0)

• Proportion of sex ratio at inclusion in the two randomization groups.

  At baseline (Day 0)

• Mean age at inclusion in the two randomization groups.

  At baseline (Day 0)

Study Arms (2)

clopidogrel

EXPERIMENTAL

Drug: clopidogrel treatment

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

clopidogrel treatment DRUG

75 mg daily during 24 months

clopidogrel

Placebo DRUG

75 mg daily during 24 months

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient who accepts to participate to the study and signs an inform consent form.

You may not qualify if:

• 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.
• Patient treated by anticoagulants at screening
• Pregnant or breastfeeding women.
• Women of childbearing age refusing effective contraception method during the study treatment (24 months).
• Incompetent adults (i.e. Individuals under the protection of a conservator)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry for Health and Solidarity, France: collaborator

Study Sites (10)

CH de la Cote Basque - service de rhumatologie

Bayonne, France

RECRUITING

CHU de Bordeaux - service de Médecine Interne et Maladies Infectieuses

Bordeaux, France

NOT YET RECRUITING

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

RECRUITING

CHU de Brest - service de rhumatologie

Brest, France

RECRUITING

CHU de Grenoble Alpes - service de médecine vasculaire

Grenoble, France

NOT YET RECRUITING

CH de Libourne - service de rhumatologie

Libourne, France

RECRUITING

CH de Mont-de-Marsan - service de rhumatologie

Mont-de-Marsan, France

RECRUITING

AP-HP - Hôpital Cochin - service de médecine interne

Paris, France

RECRUITING

CH de Pau - service de médecine interne

Pau, France

RECRUITING

CHU de Toulouse - service de médecine interne

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Marie-Elise TRUCHETET, Prof

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Linda WITTKOP, MD

  University of Bordeaux

  STUDY CHAIR

Central Study Contacts

Marie-Elise TRUCHETET, Prof

CONTACT

05.56.79.55.56; marie-elise.truchetet@chu-bordeaux.fr

Thomas BARNETCHE, PhD

CONTACT

thomas.barnetche@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: placebo-controlled trial

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 28, 2021
• Study Start: June 22, 2022
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

FR (10)