This study is a Phase III, multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial investigating the treatment of lower extremity venous thrombosis associated with Behçet's Disease. The study compares the effectiveness and safety of immunosuppressive therapy alone versus immunosuppressive therapy combined with oral anticoagulation (Rivaroxaban).
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Participants must meet the following criteria to be eligible for the study:
Age between 18-50 years old. Diagnosed with Behçet's Disease according to the International Study Group (ISG) criteria.
No prior vascular involvement or no previous immunosuppressive therapy for vascular involvement.
Confirmed venous thrombosis in the lower extremity within the last 14 days before randomization.
Venous thrombosis diagnosis confirmed by:
Non-compressible venous segment in ultrasound, OR A significant (\>4 mm) increase in thrombus diameter in an already abnormal segment, OR New intraluminal filling defect on venography, CT, or MR angiography.
Female participants must:
Not be pregnant or breastfeeding. Use effective contraception if of childbearing potential. Be postmenopausal (no menses for at least 1 year) or have undergone surgical sterilization.
Ability to provide written informed consent and comply with study requirements.
Exclusion Criteria:
* Participants will be excluded if they meet any of the following criteria:
Presence of any aneurysm. Chronic multisystemic disease other than Behçet's Disease. History of intolerance to Rivaroxaban. Use of immunosuppressive drugs (azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, TNF inhibitors, or interferon-gamma) within the last 6 months.
Prolonged corticosteroid use (\>3 months) for Behçet's Disease mucocutaneous symptoms.
Prior anticoagulant therapy:
Low molecular weight heparin, fon…