Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome

Ki vehet részt

• 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)
• Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study

Ki nem vehet részt

• Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
• Isolated superficial thrombosis without concomitant deep venous thrombosis
• 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
• Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit
• Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
• Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study
• Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)
• Severe chronic renal (creatinine clearance <30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
• Platelet count < 50 x 103/mm3
• Pregnancy or lactation