Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
This research is investigating if a treatment called clopidogrel, a medication that helps prevent blood clots, can stop a serious autoimmune disease known as systemic sclerosis (also called scleroderma) from fully developing. Systemic sclerosis is a condition where the body's immune system attacks its own tissues, leading to hardened skin, internal organ problems, and circulation issues. Currently, there isn't a cure. The study focuses on people who have early signs of systemic sclerosis, such as a specific type of blood test result (autoantibodies) and a circulation problem called Raynaud's phenomenon. Researchers believe that clopidogrel might work by calming overactive blood cells called platelets, which seem to play a role in the disease's development. This is a Phase 2/3 study, meaning it's well into testing the medication's effectiveness and safety.
At a glance
What is this study about?
Systemic sclerosis, often called scleroderma, is a chronic illness where your immune system mistakenly attacks healthy parts of your body. This can lead to hardening of the skin, problems with blood vessels, and damage to internal organs. There's currently no cure for it, so finding ways to prevent or slow its progression is really important.
Researchers have noticed that some people show early warning signs of systemic sclerosis before they develop the full illness. These signs include having a specific type of abnormal protein in their blood (called autoantibodies) along with a condition called Raynaud's phenomenon, which causes fingers and toes to feel numb and cold in response to cold temperatures or stress. About half of these individuals will go on to develop full systemic sclerosis within five years.
This study is looking at whether an existing medication called clopidogrel could help prevent systemic sclerosis from developing in these people with early signs. Clopidogrel is a blood thinner that works by making blood cells called platelets less sticky. Scientists believe that overactive platelets might play a key role in causing the blood vessel damage and scarring seen in systemic sclerosis. Lab tests and studies in animals have suggested that clopidogrel might help protect against these changes, and this trial aims to see if it works in humans.
Key takeaways
- This study investigates if clopidogrel can prevent systemic sclerosis.
- It focuses on people with early risk factors: specific antibodies and Raynaud's.
- Participation involves taking a study drug (or placebo) for two years.
- Regular health checks and blood tests will occur over five years.
- This research hopes to find a way to stop the disease before it progresses.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 85 years old. You must have specific types of antibodies in your blood that are linked to systemic sclerosis and also experience Raynaud's phenomenon, which your doctor should confirm. You also need to be part of a health insurance system and be willing to give your informed consent, meaning you understand the study and agree to take part.
There are several reasons why someone might not be able to join. You can't participate if you've already been officially diagnosed with systemic sclerosis, or if you have skin hardening that's already visible. If you are already taking blood-thinning medications that affect platelets or other strong immune-suppressing drugs, you won't be able to join either. The study also excludes pregnant or breastfeeding women, and women of childbearing age who are not willing to use effective contraception throughout the study's treatment period.
Additionally, if you have any medical conditions that would make clopidogrel unsafe for you to take, or if you are deemed unable to make your own decisions about participating in a study (for example, if you have a legal guardian), you would not be eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 85 years old?
- Do you have a diagnosis of Raynaud's phenomenon confirmed by a doctor?
- Do your blood tests show specific anti-nuclear antibodies (autoantibodies) linked to systemic sclerosis?
- Are you currently NOT diagnosed with full systemic sclerosis?
- Are you NOT currently taking blood-thinning medications or strong immune-suppressing drugs?
- If you are a woman who could get pregnant, are you willing to use effective contraception throughout the treatment period?
What does participation involve?
If you decide to take part in this study, you would receive either clopidogrel (a 75mg tablet once a day) or a placebo (a dummy pill with no active medicine) for two years. Neither you nor your study doctor will know whether you are taking the actual medication or the placebo – this is called a "double-blind" study and helps ensure fair results. Alongside the treatment, you will be followed closely for a total of five years.
During this five-year period, you'll have regular check-ups every six months. These visits will involve a physical examination, answering questions about how you're feeling (these are called patient-reported outcomes), and giving blood samples for testing. The two-year treatment phase is followed by a three-year observation phase where your health continues to be monitored.
Potential risks and benefits
Locations (10)
- CH de la Cote Basque - service de rhumatologieVerified postcodeBayonne, France· Recruiting
- CHU de Bordeaux - service de Médecine Interne et Maladies InfectieusesVerified postcodeBordeaux, France· Not yet recruiting
- CHU de Bordeaux - service de rhumatologieVerified postcodeBordeaux, France· Recruiting
- CHU de Brest - service de rhumatologieVerified postcodeBrest, France· Recruiting
- CHU de Grenoble Alpes - service de médecine vasculaireVerified postcodeGrenoble, France· Not yet recruiting
- CH de Libourne - service de rhumatologieVerified postcodeLibourne, France· Recruiting
- CH de Mont-de-Marsan - service de rhumatologieVerified postcodeMont-de-Marsan, France· Recruiting
- AP-HP - Hôpital Cochin - service de médecine interneVerified postcodeParis, France· Recruiting
- CH de Pau - service de médecine interneVerified postcodePau, France· Recruiting
- CHU de Toulouse - service de médecine interneVerified postcodeToulouse, France· Not yet recruiting
Common questions
What is systemic sclerosis (scleroderma)?
It's a rare, serious illness where your immune system attacks your body, causing skin hardening, blood vessel problems, and potential damage to internal organs.
What is Raynaud's phenomenon?
It's a common condition where blood vessels in your fingers and toes overreact to cold or stress, causing them to turn white, then blue, and feel numb or tingly.
What is clopidogrel?
Clopidogrel is a medicine that helps prevent blood clots by making blood cells called platelets less sticky. It's often used after heart attacks or strokes.
What does 'double-blinded' mean?
It means that neither you nor your study doctor will know whether you are receiving the actual study medication (clopidogrel) or a placebo (a dummy pill) during the trial.
How long will the study last if I join?
The total follow-up period will be five years, with two years of taking the study medication or placebo, followed by three years of observation.
How to find out more
Marie-Elise TRUCHETET, Prof
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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