Clinical trial NCT06780462: Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
Official title: Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Behcet Syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled, multicentre, superiority study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Diagnosis of BS according to the international criteria
3. First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)
4. Written inform consent
5. 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).
6. Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study

Exclusion Criteria:

1. Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation...)
2. Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
3. Isolated superficial thrombosis without concomitant deep venous thrombosis.
4. Pregnancy or lactation
5. Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone equivalent for more than 6 weeks continuously prior to the inclusion visit or taking more than 4000 mg methylprednisolone 4 weeks prior to the inclusion visit
6. Have been taking anti-coagulation therapy for more than 4 weeks prior to inclusion
7. Severe chronic renal (creatinine clearance \<30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
8. Platelet count \< 50 x 103/mm3
9. Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit.
10. Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
11. Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study

Primary outcomes:
measure: Rate of success
timeFrame: At 6 months
Secondary outcomes:
measure: Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse
timeFrame: At 12 months
measure: Cumulative incidence of major venous thrombosis
timeFrame: At 12 months
measure: Cumulative incidence of venous repermeabilization
timeFrame: At 6 months
measure: Proportion of patients with a dose ≤ 5 mg/day of prednisone
timeFrame: At 6 months
measure: Proportion of patients with a dose ≤ 5 mg/day of prednisone
timeFrame: At 12 months
measure: Dose of prednisone
timeFrame: At 3 months
measure: Dose of prednisone
timeFrame: At 6 months
measure: Dose of prednisone
timeFrame: At 12 months
measure: Cumulative dose of prednisone
timeFrame: At 3 months
measure: Cumulative dose of prednisone
timeFrame: At 6 months
measure: Cumulative dose of prednisone
timeFrame: At 12 months
measure: Cumulative incidence of major bleeding event
timeFrame: At 12 months
measure: Cumulative incidence of bleeding event
timeFrame: At 12 months
measure: Number of adverse events
timeFrame: At 3 months
measure: Number of adverse events
timeFrame: At 6 months
measure: Number of adverse events
timeFrame: At 12 months
measure: Change in SF-36 quality-of-life
timeFrame: At 3 months
measure: Change in SF-36 quality-of-life
timeFrame: At 6 months
measure: Change in SF-36 quality-of-life
timeFrame: At 12 months
measure: Change in Behçet's Disease Current Activity Form
timeFrame: At 3 months
measure: Change in Behçet's Disease Current Activity Form
timeFrame: At 6 months
measure: Change in Behçet's Disease Current Activity Form
timeFrame: At 12 months
measure: Change in Behçet's Syndrome Assessment Score
timeFrame: At 3 months
measure: Change in Behçet's Syndrome Assessment Score
timeFrame: At 6 months
measure: Change in Behçet's Syndrome Assessment Score
timeFrame: At 12 months
measure: Change in Physician Global Assessment
timeFrame: At 3 months
measure: Change in Physician Global Assessment
timeFrame: At 6 months
measure: Change in Physician Global Assessment
timeFrame: At 12 months
measure: Overall survival
timeFrame: At 12 months
measure: Event free survival
timeFrame: At 12 months
measure: Proportion of post thrombotic syndrome
timeFrame: At 12 months
measure: Changes in Villalta's post-thrombotic syndrome scale
timeFrame: At 6 months
measure: Changes in Villalta's post-thrombotic syndrome scale
timeFrame: At 12 months
measure: Proportion of remission
timeFrame: At 3 months
measure: Proportion of remission
timeFrame: At 6 months
measure: Proportion of remission
timeFrame: At 12 months
measure: Changes in acute-phase reactants
timeFrame: At 1 month
measure: Changes in acute-phase reactants
timeFrame: At 3 months
measure: Changes in acute-phase reactants
timeFrame: At 6 months
measure: Changes in acute-phase reactants
timeFrame: At 12 months
Other outcomes:
Locations:
Study officials:
References: