Immunosuppressive Therapy Alone Versus Plus Oral Anticoagulation in the Treatment of VT Associated With Behcet's Disease

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2028

Conditions
Behcet DiseaseBehcet Disease and Vascular InvolvementDeep Venous ThrombosesPost Thrombotic Syndrome
Interventions
DRUG

Placebo plus immunosuppression

"Participants 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."

DRUG

Rivaroxaban plus immunosupression

"Participants 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."

Trial Locations (2)

Unknown

Marmara University, School of Medicine, Division of Rheumatology, Istanbul

Marmara University, Istanbul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Health Institutes of Turkey

OTHER_GOV

lead

Marmara University

OTHER

NCT06925698 - Immunosuppressive Therapy Alone Versus Plus Oral Anticoagulation in the Treatment of VT Associated With Behcet's Disease | Biotech Hunter | Biotech Hunter