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Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk (PSSIT)

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ClinicalTrials.gov Identifier: NCT05098704
Recruitment Status : Recruiting
First Posted : October 28, 2021
Last Update Posted : October 18, 2022
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE October 4, 2021
First Posted Date  ICMJE October 28, 2021
Last Update Posted Date October 18, 2022
Actual Study Start Date  ICMJE June 22, 2022
Estimated Primary Completion Date June 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2021)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2021)
  • 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) ]
  • 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) ]
  • 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) ]
  • Proportion of sex ratio at inclusion in the two randomization groups. [ Time Frame: At baseline (Day 0) ]
  • Mean age at inclusion in the two randomization groups. [ Time Frame: At baseline (Day 0) ]
  • Proportion of patients exposed to toxic products at inclusion in the two randomization groups. [ Time Frame: At baseline (Day 0) ]
  • Proportion of patients exposed to toxic products at 5 years in the two randomization groups. [ Time Frame: 60 months after baseline (Day 0) ]
  • Proportion of patients affected by a limited form of SSc at 5 years in the two randomization groups. [ Time Frame: 60 months after baseline (Day 0) ]
  • Proportion of patients affected by a diffuse form of SSc at 5 years in the two randomization groups. [ Time Frame: 60 months after baseline (Day 0) ]
  • Proportion of patients presenting a specific antibody positivity (anti-scl70, anti-centromere) in the two randomization groups at inclusion. [ Time Frame: At baseline (Day 0) ]
  • Proportion of patients presenting megacapillaries by capillaroscopy at 5 years in the two randomization groups. [ Time Frame: 60 months after baseline (Day 0) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Official Title  ICMJE 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
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.
Detailed Description

In this study, platelet activation is targeted as it could play a key role in the pathogenesis of SSc. It has been shown in several publications that platelets are activated in SSc with a correlation between the level of activation and disease activity. Secondary to this activation, soluble and membrane effectors were increased, and induced vascular damages and fibrosis. The results obtained in the laboratory (CNRS UMR-5164) directly involved platelets in this mechanism by inducing the thymic stromal lymphopoietin (TSLP) production by endothelial cells and by showing the pro-fibrotic effect of TSLP. In vivo data in SSc murine model recently obtained, confirmed the preventive role on fibrosis of clopidogrel. The early control of this platelet activation could prevent the course of events leading to SSc.

The therapeutic strategy assessed in this study will be the oral administration of clopidogrel (75 mg per day) during two years to subjects presenting an association of specific dysimmunity and Raynaud phenomenon (RP). The administration of clopidogrel will be double-blinded versus placebo.

Subjects will be included and treated during a 2-year period and will be followed for a period of 36 months after treatment, i.e. a total of 60 months. The follow-up will be every six months mainly comprising clinical examination, patient reported outcomes and blood sampling.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
placebo-controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Scleroderma
  • Systemic Sclerosis
Intervention  ICMJE
  • Drug: clopidogrel treatment
    75 mg daily during 24 months
  • Drug: Placebo
    75 mg daily during 24 months
Study Arms  ICMJE
  • Experimental: clopidogrel
    Intervention: Drug: clopidogrel treatment
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 15, 2021)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2029
Estimated Primary Completion Date June 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, 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.

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.
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie-Elise TRUCHETET, Prof 05.56.79.55.56 ext +33 marie-elise.truchetet@chu-bordeaux.fr
Contact: Thomas BARNETCHE, PhD thomas.barnetche@chu-bordeaux.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05098704
Other Study ID Numbers  ICMJE CHUBX 2017/45
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Bordeaux
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Bordeaux
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministry for Health and Solidarity, France
Investigators  ICMJE
Principal Investigator: Marie-Elise TRUCHETET, Prof CHU Bordeaux
Study Chair: Linda WITTKOP, MD University of Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP