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

Sponsor
Marmara University
Study ID
NCT06925698
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Behcet Disease
  • Behcet Disease and Vascular Involvement
  • Deep Venous Thromboses
  • Post Thrombotic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo plus immunosuppression — DRUG
    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.
  • Rivaroxaban plus immunosupression — DRUG
    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.

Study Details

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).

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Immunosuppressive Therapy + Placebo
    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) + Placebo
  • Active Comparator: Immunosuppressive Therapy + Rivaroxaban
    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), plus Rivaroxaban (20 mg/day, oral, for 12 months)

Primary Outcome Measure

Rate of Thrombotic Relapse at 52 Weeks [ Time Frame: 52 weeks ]

Central Contacts

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