Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid … (NCT06780462) | Clinical Trial Compass
RecruitingPhase 3
Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
France134 participantsStarted 2025-06-24
Plain-language summary
In patients with Behçet's syndrome (BS), deep venous thrombosis (DVT) is thought to result from inflammation of the vessel wall rather than hyper coagulability.
Post Thrombotic Syndrome (PTS) is frequent especially with recurrent episodes of deep vein thrombosis and may result in leg ulcers that are very difficult to treat. Vascular involvement is a major cause of morbidity and mortality among BS patients. However, one of the most controversial issues regarding the management of BS is whether DVT should be treated with anticoagulants. Moreover, use of anticoagulants exposes patients to serious bleeding, especially in those who presents simultaneous arterial aneurysms. However, many physicians are still using anticoagulants. This is the first prospective, randomized study assessing benefits of corticosteroids associated with anticoagulant compared to that of corticosteroids alone in DVT in BS patients. It will validate or not the use of anticoagulants in those situations. It will allow a direct comparison of the safety profile of those two schemes of treatment.
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
. Age ≥ 18 years old
. Diagnosis of BS according to the international criteria
. First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
. Written inform consent
. Women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment highly effective contraception (ie, abstinence, combined estrogen- and progestogen- containing hormonal contraception, ovulation inhibitors (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner).
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 is a Phase 3 trial comparing steroids plus anticoagulants versus steroids alone for deep vein thrombosis in Behçet's — given that anticoagulants carry bleeding risks, what does my doctor think about whether adding them is likely to help or harm in my specific situation?
2Since the trial is still recruiting and the results aren't in yet, does my doctor feel there's already enough evidence to guide my treatment for Behçet's-related deep vein thrombosis outside of a trial, or would joining this study be the better path for me?
3The trial measures 'rate of success' as its main outcome — can my doctor explain what that likely means in practice, such as clot resolution or symptom improvement, and how that goal lines up with what matters most to me?
4Because this is a multicenter study, would I need to travel to a participating center for treatment and monitoring, and how would that fit with my current care and daily life?
5If I'm not a good fit for this trial or choose not to enroll, what is the standard of care my doctor would recommend for treating deep vein thrombosis related to Behçet's syndrome right now?
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.
. Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
Exclusion criteria
. Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)
. Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
. Isolated superficial thrombosis without concomitant deep venous thrombosis.
. Pregnancy or lactation
. Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 4000 mg methylprednisolone 4 weeks prior to the inclusion visit
. Have been taking anti-coagulation therapy for more than 4 weeks prior to inclusion
. Severe chronic renal (creatinine clearance \<30ml/min/1,73m2) or liver insufficiency associated with coagulopathy