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

Overview

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.

Interventions

• Drug Corticosteroids + 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
• Drug Corticosteroids alone
  Corticosteroids according to the schedule of reduction of prednisone (or equivalent prednisone dose only if prednisone is out of stock in the market)

Primary outcome measures

• Rate of success [Time frame: At 6 months]

Secondary outcome measures (12)

• Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse [Time frame: At 12 months]
• Cumulative incidence of major venous thrombosis [Time frame: At 12 months]
• Cumulative incidence of venous repermeabilization [Time frame: At 6 months]
• Proportion of patients with a dose ≤ 5 mg/day of prednisone [Time frame: At 6 months]
• Proportion of patients with a dose ≤ 5 mg/day of prednisone [Time frame: At 12 months]
• Dose of prednisone [Time frame: At 3 months]
• Dose of prednisone [Time frame: At 6 months]
• Dose of prednisone [Time frame: At 12 months]
• Cumulative dose of prednisone [Time frame: At 3 months]
• Cumulative dose of prednisone [Time frame: At 6 months]
• Cumulative dose of prednisone [Time frame: At 12 months]
• Cumulative incidence of major bleeding event [Time frame: At 12 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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
• Have been taking anti-coagulation therapy for more than 4 weeks prior to inclusion
• Severe chronic renal (creatinine clearance <30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
• Platelet count < 50 x 103/mm3
• Change in the treatment with systemic biologic therapy or immunosuppressant therapy dose 1 month prior to inclusion visit.
• Contraindication to investigational medicinal products (Corticosteroids and direct oral anticoagulant (Rivaroxaban))
• Participation to another interventional clinical trial or being in the exclusion period at the end of a previous study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 17 centers

• CHU BORDEAUX Hôpital Saint-André — Bordeaux
• Ambroise Paré hospital AP-HP — Boulogne-Billancourt
• CHU Caen — Caen
• Hopital Henri Mondor AP-HP — Créteil
• Chu de Grenoble — Grenoble
• Hôpital Bicêtre — Le Kremlin-Bicêtre
• Hcl, Hopital de La Croix Rousse — Lyon
• Centre Hospitalier de Melun — Melun
• … and 9 more centers

Identifiers

NCT: NCT06780462 · APHP220673

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗