[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587231":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":110,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Marmara University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immunosuppressive Therapy + Placebo","PLACEBO_COMPARATOR","Azathioprine (2.5 mg\u002Fkg\u002Fday, maximum 200 mg\u002Fday, oral) Methylprednisolone (0.5 mg\u002Fkg\u002Fday, oral, tapered over 12 weeks according to protocol) + Placebo",[13],"Drug: Placebo plus immunosuppression",{"label":15,"type":16,"description":17,"interventionNames":18},"Immunosuppressive Therapy + Rivaroxaban","ACTIVE_COMPARATOR","Azathioprine (2.5 mg\u002Fkg\u002Fday, maximum 200 mg\u002Fday, oral) Methylprednisolone (0.5 mg\u002Fkg\u002Fday, oral, tapered over 12 weeks according to protocol), plus Rivaroxaban (20 mg\u002Fday, oral, for 12 months)",[19],"Drug: Rivaroxaban plus immunosupression",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Placebo plus immunosuppression","Participants in this arm will receive placebo plus standard immunosuppressive therapy consisting of:\n\nAzathioprine (2.5 mg\u002Fkg\u002Fday, maximum 200 mg\u002Fday, oral) Methylprednisolone (0.5 mg\u002Fkg\u002Fday, 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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Rivaroxaban plus immunosupression","Participants in this arm will receive standard immunosuppressive therapy as described above, plus Rivaroxaban (20 mg\u002Fday, oral, for 12 months).\n\nThis 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.",[15],[32],{"name":33,"affiliation":5,"role":34},"Fatma Alibaz-Oner, Prof","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+90 216 625 45 45","falibaz@gmail.com",[41,72],{"facility":42,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":26,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Marmara University, School of Medicine, Division of Rheumatology","Istanbul","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],28.94966,41.01384,{"lat":49,"lon":48},[52,53,55,58,60,62,64,66,68,70],{"name":26,"role":37,"phone":26,"phoneExt":26,"email":39},{"name":54,"role":34,"phone":26,"phoneExt":26,"email":26},"Fatma Alibaz Oner, Prof",{"name":56,"role":57,"phone":26,"phoneExt":26,"email":26},"Kerem Abacar, MD","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":26,"phoneExt":26,"email":26},"Haner Direskeneli, Prof",{"name":61,"role":57,"phone":26,"phoneExt":26,"email":26},"Ahmet Gül, Prof",{"name":63,"role":57,"phone":26,"phoneExt":26,"email":26},"Cemal Bes, Prof",{"name":65,"role":57,"phone":26,"phoneExt":26,"email":26},"Ayten Yazici, Prof",{"name":67,"role":57,"phone":26,"phoneExt":26,"email":26},"Ömer Karadağ, Prof",{"name":69,"role":57,"phone":26,"phoneExt":26,"email":26},"Mehmet Akif Öztürk, Prof",{"name":71,"role":57,"phone":26,"phoneExt":26,"email":26},"Ahmet Omma, Ass. Prof",{"facility":5,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":26,"cosmosGeoPoint":73,"geoPoint":75,"contacts":26},{"type":46,"coordinates":74},[48,49],{"lat":49,"lon":48},{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[79],{"name":80,"class":81},"Health Institutes of Turkey","OTHER_GOV","100587231","phase-3-immunosuppressive-therapy-alone-versus-plus-oral-anticoagulation-in-the-treatment-of-vt-associated-with-behcets-disease-100587231",false,"NCT06925698","Immunosuppressive Therapy Alone Versus Plus Oral Anticoagulation in the Treatment of VT Associated With Behcet's Disease","Immunosuppressive Therapy Alone Versus Immunosuppressive Therapy Plus Oral Anticoagulation in the Treatment of Lower Extremity Venous Thrombosis Associated With Behcet's Disease","BETTER","Inclusion Criteria:\n\n* Participants must meet the following criteria to be eligible for the study:\n\nAge between 18-50 years old. Diagnosed with Behçet's Disease according to the International Study Group (ISG) criteria.\n\nNo prior vascular involvement or no previous immunosuppressive therapy for vascular involvement.\n\nConfirmed venous thrombosis in the lower extremity within the last 14 days before randomization.\n\nVenous thrombosis diagnosis confirmed by:\n\nNon-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.\n\nFemale participants must:\n\nNot 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.\n\nAbility to provide written informed consent and comply with study requirements.\n\nExclusion Criteria:\n\n* Participants will be excluded if they meet any of the following criteria:\n\nPresence 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.\n\nProlonged corticosteroid use (\\>3 months) for Behçet's Disease mucocutaneous symptoms.\n\nPrior anticoagulant therapy:\n\nLow molecular weight heparin, fondaparinux, or unfractionated heparin for \\>48 hours before randomization.\n\nMore than one dose of vitamin K antagonists before randomization. Thrombectomy, vena cava filter placement, or fibrinolytic therapy for the current thrombotic episode.\n\nPlanned administration of a live vaccine within 30 days after randomization. Clinically significant acute or uncontrolled chronic diseases (e.g., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) that may interfere with study results.\n\nPlanned surgical procedure or significant medical condition deemed unsuitable for the study by the investigator.\n\nHistory of malignancy within the last 5 years (except adequately treated basal or squamous cell carcinoma or carcinoma in situ of the cervix).\n\nRenal impairment (Creatinine clearance \\\u003C30 ml\u002Fmin). Severe liver disease (e.g., acute hepatitis, active chronic hepatitis, cirrhosis, or ALT \\>3 times the upper limit).\n\nActive bleeding or high bleeding risk contraindicating anticoagulant therapy. Uncontrolled hypertension (SBP \\>180 mmHg or DBP \\>110 mmHg). Severe anemia (Hemoglobin \\\u003C10 mg\u002FdL). Women who are pregnant, breastfeeding, or of childbearing potential without contraception.\n\nUse of strong CYP3A4 inhibitors or inducers (e.g., protease inhibitors, systemic ketoconazole, rifampin, carbamazepine, phenytoin).\n\nParticipation in another experimental drug study within the last 30 days. Life expectancy of less than 3 months. History of serious infections within the last 60 days (e.g., bacterial endocarditis, tuberculosis, opportunistic infections).\n\nActive substance or alcohol abuse or history of substance dependence within the last year.\n\nPositive screening for Hepatitis B surface antigen, Hepatitis C antibody, or known HIV-1 infection.\n\nKnown coagulation disorders or laboratory abnormalities (e.g., DMID toxicity scale Grade 3 or higher).\n\nHistory of suicidal behavior in the last 6 months or suicidal ideation (C-SSRS type 4 or 5) in the last 2 months.","ALL","18 Years","50 Years",{"count":94,"type":95},110,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","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).",[101,102,103,104],"Behcet Disease","Behcet Disease and Vascular Involvement","Deep Venous Thromboses","Post Thrombotic Syndrome",[106,107,108,109],"Behcet's disease","Deep venous thrombosis","Anticoagulant therapy","Rivaroxaban","NOT_YET_RECRUITING","2025-04-07",{"date":113,"type":114},"2025-04-13","ACTUAL",{"date":116,"type":95},"2025-04-30",{"date":118,"type":95},"2028-04-01",{"name":5,"class":6},2]