Preventive Effect of Clopidogrel on the Systemic Sclerosis Development

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05098704
Study type	Interventional
Source	University Hospital, Bordeaux
Contact	Marie-Elise TRUCHETET, Prof
Phone	05.56.79.55.56
Email	marie-elise.truchetet@chu-bordeaux.fr
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	June 22, 2022
Completion date	June 2030

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See also
Status	Clinical Trial	Phase
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Completed	`NCT01468792` - Hemodynamic Changes in Connective Tissue Disease	N/A
Terminated	`NCT00848107` - Open-Label Study of Oral Treprostinil in Digital Ulcers	Phase 2
Completed	`NCT00984932` - Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension	Phase 3
Completed	`NCT00074568` - Scleroderma Registry
Not yet recruiting	`NCT06412614` - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Terminated	`NCT00622687` - Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis	Phase 2
Recruiting	`NCT04464434` - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis	Phase 4
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk — PSSIT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms