RecruitingPhase 3NCT06780462

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

Enrollment

134 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Corticosteroids + Rivaroxaban and a drug called Corticosteroids alone for people with behcet syndrome. The study is currently recruiting participants at 17 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCorticosteroids + 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

DRUGCorticosteroids 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06780462


Related Trials