Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
ACTOR
1 other identifier
interventional
134
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2025
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 24, 2028
April 23, 2026
April 1, 2026
2.5 years
January 13, 2025
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
At 6 months
Secondary Outcomes (40)
Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse
At 12 months
Cumulative incidence of major venous thrombosis
At 12 months
Cumulative incidence of venous repermeabilization
At 6 months
Proportion of patients with a dose ≤ 5 mg/day of prednisone
At 6 months
Proportion of patients with a dose ≤ 5 mg/day of prednisone
At 12 months
- +35 more secondary outcomes
Study Arms (2)
Corticosteroids and Rivaroxaban
EXPERIMENTALCorticosteroids alone
ACTIVE COMPARATORInterventions
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 according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market)
Eligibility Criteria
You may qualify if:
- 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
- Women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment highly effective contraception (ie, abstinence, combined estrogen- and progestogen- containing hormonal contraception, ovulation inhibitors (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner).
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
You may not qualify if:
- 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
- Severe chronic renal (creatinine clearance \<30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
- Platelet count \< 50 x 103/mm3
- Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2025
First Posted
January 17, 2025
Study Start
June 24, 2025
Primary Completion (Estimated)
December 24, 2027
Study Completion (Estimated)
June 24, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04