Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

In patients with Behçet's syndrome (BS), deep venous thrombosis (DVT) is thought to result from inflammation of the vessel wall rather than hyper coagulability.

Post Thrombotic Syndrome (PTS) is frequent especially with recurrent episodes of deep vein thrombosis and may result in leg ulcers that are very difficult to treat. Vascular involvement is a major cause of morbidity and mortality among BS patients. However, one of the most controversial issues regarding the management of BS is whether DVT should be treated with anticoagulants. Moreover, use of anticoagulants exposes patients to serious bleeding, especially in those who presents simultaneous arterial aneurysms. However, many physicians are still using anticoagulants. This is the first prospective, randomized study assessing benefits of corticosteroids associated with anticoagulant compared to that of corticosteroids alone in DVT in BS patients. It will validate or not the use of anticoagulants in those situations. It will allow a direct comparison of the safety profile of those two schemes of treatment.

Eligibility criteria

Qualifiers

Age ≥ 18 years old

Diagnosis of BS according to the international criteria

First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)

Written inform consent

Disqualifiers

Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)

Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants

Isolated superficial thrombosis without concomitant deep venous thrombosis.

Pregnancy or lactation

Trial design

Treatments tested in this trial

  • Corticosteroids + Rivaroxaban
  • Corticosteroids alone

Treatment groups

134 Participants
are divided into 2 treatment groups