Actively Recruiting
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
Eligibility Criteria
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)
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
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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
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
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