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

Last updated: January 13, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lupus

Claudication

Venous Thrombosis

Treatment

Corticosteroids + Rivaroxaban

Corticosteroids alone

Clinical Study ID

NCT06780462
APHP220673
  • Ages > 18
  • All Genders

Study 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

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 (venousultrasonography , 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 pregnancytest before treatment and must agree to maintain during treatment highly effectivecontraception (ie, abstinence, combined estrogen- and progestogen- containinghormonal contraception, ovulation inhibitors (Oral, Intravaginal, Transdermal);Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterinehormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner).

  6. Affiliation to a social security system. Patients affiliated to universal medicalcoverage (CMU) are eligible for the study

Exclusion

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 withanticoagulants

  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 mgprednisone equivalent for more than 6 weeks continuously prior to the inclusionvisit or taking more than 4000 mg methylprednisolone 4 weeks prior to the inclusionvisit

  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 insufficiencyassociated with coagulopathy

  8. Platelet count < 50 x 103/mm3

  9. Change in the treatment with systemic biologic therapy or immunosuppressant therapydose 1 month prior to inclusion visit.

  10. Contraindication to investigational medicinal products (Corticosteroids and directoral anticoagulant (Rivaroxaban))

  11. Participation to another interventional clinical trial or being in the exclusionperiod at the end of a previous study

Study Design

Total Participants: 134
Treatment Group(s): 2
Primary Treatment: Corticosteroids + Rivaroxaban
Phase: 3
Study Start date:
January 15, 2025
Estimated Completion Date:
January 15, 2028