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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

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.

Condition or disease Intervention/treatment Phase
Scleroderma Systemic Sclerosis Drug: clopidogrel treatment Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo-controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : June 2029
Estimated Study Completion Date : June 2029


Arm Intervention/treatment
Experimental: clopidogrel Drug: clopidogrel treatment
75 mg daily during 24 months

Placebo Comparator: placebo Drug: Placebo
75 mg daily during 24 months




Primary Outcome Measures :
  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 [ Time Frame: 60 months after baseline (Day 0) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Proportion of sex ratio at inclusion in the two randomization groups. [ Time Frame: At baseline (Day 0) ]
  5. Mean age at inclusion in the two randomization groups. [ Time Frame: At baseline (Day 0) ]
  6. Proportion of patients exposed to toxic products at inclusion in the two randomization groups. [ Time Frame: At baseline (Day 0) ]
  7. Proportion of patients exposed to toxic products at 5 years in the two randomization groups. [ Time Frame: 60 months after baseline (Day 0) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. Proportion of patients presenting megacapillaries by capillaroscopy at 5 years in the two randomization groups. [ Time Frame: 60 months after baseline (Day 0) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05098704


Contacts
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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

Locations
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France
CHU de Bordeaux - service de rhumatologie Recruiting
Bordeaux, France
Contact: Marie-Elise TRUCHETET, Prof       marie-elise.truchetet@chu-bordeaux.fr   
Contact: Thomas BARNETCHE, PhD       thomas.barnetche@chu-bordeaux.fr   
Principal Investigator: Marie-Elise TRUCHETET, Prof         
Sub-Investigator: Joel CONSTANS, Prof         
Sub-Investigator: Pierre DUFFAU, Prof         
Sub-Investigator: Julien SENESCHAL, Prof         
Sub-Investigator: Estibaliz LAZARO, Prof         
CHU de Brest - service de rhumatologie Not yet recruiting
Brest, France
Contact: Alain SARAUX, Prof       alain.saraux@chu-brest.fr   
Principal Investigator: Alain SARAUX, Prof         
CH de Libourne - service de rhumatologie Not yet recruiting
Libourne, France
Contact: Jean-Philippe VERNHES, MD       philippe.vernhes@ch-libourne.fr   
Principal Investigator: Jean-Philippe VERNHES, MD         
CHU de Limoges - Service de médecine interne Not yet recruiting
Limoges, France
Contact: Anne-Laure FAUCHAIS, Prof       anne-laure.fauchais@unilim.fr   
Principal Investigator: Anne-Laure FAUCHAIS, Prof         
CH de Mont-de-Marsan - service de rhumatologie Not yet recruiting
Mont-de-Marsan, France
Contact: Marion MIRABEL, MD       marion.mirabel@ch-mdm.fr   
Principal Investigator: Marion MIRABEL, MD         
CHU de Montpellier - service de médecine vasculaire Not yet recruiting
Montpellier, France
Contact: Pierrick HENNETON, MD       p-henneton@chu-montpellier.fr   
Principal Investigator: Pierrick HENNETON, MD         
AP-HP - Hôpital Cochin - service de médecine interne Not yet recruiting
Paris, France
Contact: Benjamin CHAIGNE, MD       benjamin.chaigne@aphp.fr   
Principal Investigator: Benjamin CHAIGNE, MD         
CH de Pau - service de médecine interne Not yet recruiting
Pau, France
Contact: Xavier DELBREL, MD       xavier.delbrel@ch-pau.fr   
Principal Investigator: Xavier DELBREL, MD         
CHU de Toulouse - service de médecine interne Not yet recruiting
Toulouse, France
Contact: Grégory PUGNET, MD       pugnet.g@chu-toulouse.fr   
Principal Investigator: Grégory PUGNET, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Investigators
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Principal Investigator: Marie-Elise TRUCHETET, Prof CHU Bordeaux
Study Chair: Linda WITTKOP, MD University of Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT05098704    
Other Study ID Numbers: CHUBX 2017/45
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
systemic sclerosis
clopidogrel
platelet
prevention
primary care
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs