Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic… (NCT02320357) | Clinical Trial Compass
CompletedPhase 1/2
Pilot Study Related to the Effect of Clopidogrel on Plasmatic Soluble CD40 Ligand During Systemic Lupus Erythematous
France18 participantsStarted 2015-08-19
Plain-language summary
CD40 Ligand (CD40L) has been identified as a key feature in systemic lupus erythematosus (SLE) pathogenesis, a systemic autoimmune disease characterized by a multiorgan involvement. As platelets are a major source of soluble CD40L (sCD40L), we propose to study the effect of clopidogrel, a platelet inhibitor, on plasmatic sCD40L levels in SLE patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of SLE according to revised criteria of American College of Rheumatology
* Being affiliated to health insurance
* Having signed an informed consent (later than the day of inclusion and before any examination required by research)
Exclusion Criteria:
* \> 20mg/day of prednisone equivalent for \> 7 days 30 days before the pre-inclusion.
* Diseases flare 3 months before the inclusion. A disease flare is defined by an increase of SLEDAI score \>3 and or a change of the immunosuppressive treatment and or an increase of steroids dose.
* Is treated or has received 3 months before the pre-inclusion steroids pulses or intravenous immunoglobulins.
* Renal involvement that could required a kidney biopsy.
* Required surgery in the next 12 weeks.
* Has been treated by cyclophosphamide 3 months before the pre-inclusion.
* Has been treated by biotherapy 6 months before the pre-inclusion.
* Contraindication to clopidogrel (annex 1).
* History of cancer except healed basal cell carcinoma.
* History of severe hemorrhage
* Disease exposing to hemorrhage
* Associated antiphospholipid syndrome
* Pregnant or breastfeeding women
* No contraception for women of childbearing age
* Severe hypertension
* Ongoing statin, non-steroidal anti-inflammatory, antiplatelet and anticoagulant drugs.
* Being under guardianship
* Patient participating at an other biomedical research with an exclusion period at the screening visit.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested clopidogrel — a blood thinner normally used for heart conditions — in people with lupus to measure its effect on a protein called sCD40L; can you explain what sCD40L is and why it might matter for my lupus specifically?
2Since this was a Phase 1/2 pilot study, what does that mean for how much we actually know about whether clopidogrel is safe and beneficial for lupus patients, and are there any published results I could review with you?
3Clopidogrel carries a risk of increased bleeding — given my current lupus treatments and overall health, is that a meaningful concern you'd want me to think carefully about before considering anything like this?
4Now that this trial is completed, do you know if the results showed anything meaningful about clopidogrel's effect on sCD40L levels in lupus, and does that change how you'd think about my treatment options?
5Are there other ongoing or completed studies building on this pilot that might be a better fit for me to discuss, or would standard lupus therapies still be the stronger first path for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.