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).
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Parallel
Placebo plus immunosuppression
DrugParticipants in this arm will receive placebo plus standard immunosuppressive therapy consisting of: Azathioprine (2.5 mg/kg/day, maximum 200 mg/day, oral) Methylprednisolone (0.5 mg/kg/day, oral, tapered over 12 weeks according to protocol) This intervention represents the standard treatment for venous thrombosis associated with Behçet's Disease and serves as the control arm of the study.
Rivaroxaban plus immunosupression
DrugParticipants in this arm will receive standard immunosuppressive therapy as described above, plus Rivaroxaban (20 mg/day, oral, for 12 months). This intervention aims to evaluate whether the addition of oral anticoagulation (Rivaroxaban) to immunosuppressive therapy reduces the risk of thrombotic relapse and post-thrombotic syndrome compared to immunosuppressive therapy alone.
Rate of Thrombotic Relapse at 52 Weeks
The primary outcome is the rate of thrombotic relapse within 52 weeks, assessed via lower extremity venous Doppler ultrasound. Thrombotic relapse is defined as: A new thrombotic event in a previously unaffected ipsilateral or contralateral vein. Re-thrombosis in a previously affected vein that was classified as well-recanalized (≥50% compressibility on Doppler ultrasound). Venous Doppler ultrasound assessments will be performed at baseline, months 1, 3, 6, 9, and 12.
Development of Post-Thrombotic Syndrome (PTS) at 52 Weeks
The occurrence of Post-Thrombotic Syndrome (PTS) will be assessed using standardized clinical scoring systems, including: Villalta Scale (PTS severity assessment) Venous Clinical Severity Score (VCSS) Venous Disability Score (VDS) Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) PTS is defined as a Villalta score ≥5 or the presence of a venous ulcer.
Rate of Venous Recanalization at 52 Weeks
Venous recanalization will be assessed via Doppler ultrasound to evaluate the extent of clot resolution in affected veins. Partial or complete recanalization will be determined based on compressibility and flow characteristics. Measured at baseline, months 1, 3, 6, 9, and 12.
Incidence of Major and Clinically Relevant Non-Major Bleeding Events
The frequency of major bleeding (as per ISTH criteria) and clinically relevant non-major bleeding will be recorded. Major bleeding: * 2.0 g/dL hemoglobin drop * 2 units of red blood cell transfusion Intracranial, retroperitoneal, or fatal bleeding Clinically relevant non-major bleeding: Epistaxis \>5 minutes, spontaneous hematomas \>25 cm², gastrointestinal bleeding not meeting major criteria.
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Marmara University
Lead sponsor
Health Institutes of Turkey
Collaborator
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