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Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2025-06-24
Completion Date
2028-06-24
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Corticosteroids + Rivaroxaban
Corticosteroids 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
Corticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market)
Locations (17)
CHU BORDEAUX Hôpital Saint-André
Bordeaux, France
Ambroise Paré hospital AP-HP
Boulogne-Billancourt, France
CHU Caen
Caen, France
Hopital Henri Mondor AP-HP
Créteil, France
Chu de Grenoble
Grenoble, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Hcl, Hopital de La Croix Rousse
Lyon, France
Centre Hospitalier de Melun
Melun, France
CHRU DE Nancy Hôpitaux de Brabois
Nancy, France
Hôpital Hôtel-Dieu
Nantes, France
Hopital Européen Georges Pompidou AP-HP
Paris, France
Hôpital Lariboisière AP-HP
Paris, France
Hôpital Saint Antoine AP-HP
Paris, France
Hôpital Tenon AP-HP
Paris, France
La Pitié Salpetriere hospital
Paris, France
CHU Bordeaux- GHU SUD hôpital Haut-Lévêque
Pessac, France
CHU DE ROUEN, Hôpital CHARLES NICOLLE
Rouen, France