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Study on Clopidogrel's Effect in Preventing Systemic Sclerosis for Patients with Raynaud's Phenomenon and Specific Immune Conditions

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Clopidogrel on reducing the risk of developing Systemic Sclerosis in individuals who have specific immune system characteristics and experience Raynaud's Phenomenon. Raynaud's Phenomenon is a condition where some areas of the body, like fingers and toes, feel numb and cold in response to cold temperatures or stress. Systemic Sclerosis is a rare disease that involves the hardening and tightening of the skin and connective tissues. The study will compare the effects of Clopidogrel with a placebo to see if it can prevent the onset of Systemic Sclerosis over a period of five years.

Participants in the study will be randomly assigned to receive either Clopidogrel or a placebo. The medication will be taken orally in the form of film-coated tablets. The study will last for up to 24 months, during which participants will be monitored for any signs of Systemic Sclerosis and other related symptoms. The goal is to determine if Clopidogrel can effectively reduce the risk of developing this condition in people who are at higher risk due to their immune system profile and symptoms of Raynaud's Phenomenon.

Throughout the study, participants will undergo regular check-ups to assess their health and any changes in their condition. The study aims to provide valuable information on whether Clopidogrel can be used as a preventive treatment for Systemic Sclerosis, potentially offering a new approach to managing this challenging disease. Participants' health and safety will be closely monitored by medical professionals throughout the trial.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must be between 18 and 85 years old and have a positive test for specific antibodies related to systemic sclerosis.

    The patient must have Raynaud phenomenon, confirmed by a physician, and be affiliated with a health insurance system.

    The patient must agree to participate and sign an informed consent form.

  2. Step 2

    Randomization and treatment

    The patient will be randomly assigned to one of two groups: one receiving the medication clopidogrel and the other receiving a placebo.

    The medication, Plavix 75 mg film-coated tablets, is taken orally.

  3. Step 3

    Treatment duration

    The treatment will continue for a period of 5 years.

    The primary goal is to assess the onset of systemic sclerosis during this time.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient will undergo regular assessments to monitor for the occurrence of systemic sclerosis and other related conditions.

    These assessments will include clinical evaluations by at least two independent investigators.

  5. Step 5

    End of trial

    The trial is expected to conclude by June 30, 2030.

    At the end of the trial, the data collected will be analyzed to determine the effectiveness of clopidogrel in preventing systemic sclerosis.

Who can join the trial?

5 criteria

  • Patient must be over 18 years old and less than 85 years old.
  • Patient must have a positive **AAN** test result. **AAN** stands for **antinuclear antibodies**, which are proteins made by the immune system that can attack the body's own cells. The test result should be 1/160 or higher, with specific types like anti-Scl70, anti-centromere, anti-RNApolIII, or other antibodies related to **systemic sclerosis**.
  • Patient must have **Raynaud phenomenon** (**RP**), which is a condition where fingers and toes change color and may feel numb or painful in response to cold or stress. This must be reported by the patient and confirmed by a doctor.
  • Patient must be affiliated with a health insurance system.
  • Patient must agree to participate in the study and sign an informed consent form, which is a document that explains the study and confirms the patient's willingness to join.

Who cannot join the trial?

5 criteria

  • Patients who have a medical condition other than **Raynaud phenomenon**. This means if you have a different health issue, you might not be able to join.
  • Patients who are not within the specified age range. The study is looking for people in certain age groups, so if you are too young or too old, you might not qualify.
  • Patients who are not part of the specified clinical trial groups. This means the study is looking for people with specific characteristics or conditions.
  • Patients who are not willing to follow the study procedures. This means you need to agree to do what the study requires.
  • Patients who are part of a vulnerable population that the study is not including. This means if you are in a group that needs special protection, you might not be able to join.
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Investigated drugs

Clopidogrel is a medication used in this trial to assess its preventive effect on the development of systemic sclerosis in patients who have specific immune system issues and experience Raynaud phenomenon. It is being tested to see if it can reduce the risk of developing this condition over a period of five years.

What is already known about the treatment

Clopidogrel – Clopidogrel is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential to prevent the development of systemic sclerosis in individuals with specific immune system issues and Raynaud phenomenon. The main therapeutic indication for Clopidogrel is to reduce the risk of blood clots, which it achieves by inhibiting platelet aggregation. At the molecular level, Clopidogrel works by blocking the P2Y12 receptor on platelets, preventing them from clumping together. It is classified as an antiplatelet medication.

Investigated diseases

Raynaud Phenomenon – Raynaud phenomenon is a condition characterized by episodes of reduced blood flow to the fingers and toes, often triggered by cold temperatures or stress. During an episode, affected areas may turn white or blue and feel cold or numb. As blood flow returns, the skin may turn red and throb or tingle. These episodes can last from minutes to hours and vary in frequency and severity. Over time, repeated episodes can lead to skin damage or ulcers. The condition is more common in women and can occur on its own or as part of other diseases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511005-39-00Protocol codeCHUBX 2017/45Estimated enrolment90 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).