Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06780462

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-23

134

Participants Needed

17

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years old
  • Diagnosis of Behet's syndrome according to international criteria
  • First or recurrent deep venous thrombosis confirmed by imaging (venous ultrasonography, Angio CT scan, or Angio MRI)
  • Written informed consent provided
  • Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during treatment
  • Affiliated to a social security system or universal medical coverage (CMU)
Not Eligible

You will not qualify if you...

  • Need for anticoagulation for conditions other than venous thrombosis (e.g., atrial fibrillation)
  • Active bleeding or high bleeding risk that contraindicates anticoagulant treatment
  • Isolated superficial thrombosis without deep venous thrombosis
  • Pregnancy or breastfeeding
  • Continuous use of glucocorticoids over 20 mg prednisone equivalent for more than 6 weeks before inclusion or more than 4000 mg methylprednisolone within 4 weeks before inclusion
  • Anticoagulation therapy for more than 4 weeks before inclusion
  • Severe chronic kidney failure (creatinine clearance <30 ml/min/1.73m2) or liver failure with coagulopathy
  • Platelet count below 50,000/mm3
  • Change in systemic biologic or immunosuppressant therapy dose within 1 month before inclusion
  • Contraindications to corticosteroids or rivaroxaban
  • Participation in another interventional clinical trial or within the exclusion period after a previous study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 17 locations

1

CHU BORDEAUX Hôpital Saint-André

Bordeaux, France

Actively Recruiting

2

Ambroise Paré hospital AP-HP

Boulogne-Billancourt, France

Actively Recruiting

3

CHU Caen

Caen, France

Actively Recruiting

4

Hopital Henri Mondor AP-HP

Créteil, France

Actively Recruiting

5

Chu de Grenoble

Grenoble, France

Actively Recruiting

6

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Actively Recruiting

7

Hcl, Hopital de La Croix Rousse

Lyon, France

Actively Recruiting

8

Centre Hospitalier de Melun

Melun, France

Actively Recruiting

9

CHRU DE Nancy Hôpitaux de Brabois

Nancy, France

Actively Recruiting

10

Hôpital Hôtel-Dieu

Nantes, France

Actively Recruiting

11

Hopital Européen Georges Pompidou AP-HP

Paris, France

Actively Recruiting

12

Hôpital Lariboisière AP-HP

Paris, France

Actively Recruiting

13

Hôpital Saint Antoine AP-HP

Paris, France

Actively Recruiting

14

Hôpital Tenon AP-HP

Paris, France

Actively Recruiting

15

La Pitié Salpetriere hospital

Paris, France

Actively Recruiting

16

CHU Bordeaux- GHU SUD hôpital Haut-Lévêque

Pessac, France

Actively Recruiting

17

CHU DE ROUEN, Hôpital CHARLES NICOLLE

Rouen, France

Actively Recruiting

Loading map...

Research Team

D

David Saadoun, MD PhD

CONTACT

J

Jérôme Lambert, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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