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.
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
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
Parallel
Corticosteroids + Rivaroxaban
DrugCorticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market) and Rivaroxaban
Corticosteroids alone
DrugCorticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market)
Rate of success
Defined as absence of deep venous thrombosis relapse and of major bleeding event, without introduction of additional immunosuppressive medication for BS activity other than thrombotic events at 6 months.
Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse
Cumulative incidence of major venous thrombosis
pulmonary embolism, vena cava , Budd Chiari syndrome , intra-cardiac relapse
Cumulative incidence of venous repermeabilization
assessed by vascular imaging
Proportion of patients with a dose ≤ 5 mg/day of prednisone
(prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)
Click on the lead sponsor to view all of their trials.
