Steroids with or without the blood thinner rivaroxaban for deep vein clots in Behçet's syndrome

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

This trial will try adding the blood thinner rivaroxaban to steroid treatment to see if adults with Behçet's syndrome and deep vein thrombosis have fewer recurrences or long-term leg problems than with steroids alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Drugs / interventions: prednisone
• Locations: 17 sites (Bordeaux and 16 other locations)
• Trial ID: NCT06780462 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, randomized trial compares two treatment approaches for deep venous thrombosis (DVT) in adults with Behçet's syndrome: corticosteroids plus rivaroxaban versus corticosteroids alone. Eligible participants are adults with a first or recurrent DVT confirmed by imaging and who meet local consent and contraceptive requirements. Participants are randomized to one of the two arms and followed for outcomes such as recurrent DVT, post-thrombotic syndrome, and bleeding events. The trial aims to provide prospective evidence to guide whether routine anticoagulation should be added to anti-inflammatory therapy in this condition.

Who should consider this trial

Good fit: Adults (18 or older) diagnosed with Behçet's syndrome who have a first or recurrent deep venous thrombosis confirmed by imaging and who can give informed consent and meet contraception/insurance requirements are ideal candidates.

Not a fit: Patients with contraindications to anticoagulation or with known arterial aneurysms (who face high bleeding risk) may not benefit and could be harmed by the anticoagulant arm.

Why it matters

Potential benefit: If positive, adding rivaroxaban to steroids could reduce DVT recurrence and long-term leg damage in people with Behçet's-associated DVT while clarifying bleeding risks.

How similar studies have performed: This is the first prospective randomized study addressing anticoagulation plus steroids versus steroids alone in Behçet's-related DVT, while prior evidence has been mostly observational and mixed.

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

Where this trial is running

Bordeaux and 16 other locations

• CHU BORDEAUX Hôpital Saint-André — Bordeaux, France (RECRUITING)
• Ambroise Paré hospital AP-HP — Boulogne-Billancourt, France (RECRUITING)
• CHU Caen — Caen, France (RECRUITING)
• Hopital Henri Mondor AP-HP — Créteil, France (RECRUITING)
• Chu de Grenoble — Grenoble, France (RECRUITING)
• Hôpital Bicêtre — Le Kremlin-Bicêtre, France (RECRUITING)
• Hcl, Hopital de La Croix Rousse — Lyon, France (RECRUITING)
• Centre Hospitalier de Melun — Melun, France (RECRUITING)
• CHRU DE Nancy Hôpitaux de Brabois — Nancy, France (RECRUITING)
• Hôpital Hôtel-Dieu — Nantes, France (RECRUITING)
• Hopital Européen Georges Pompidou AP-HP — Paris, France (RECRUITING)
• Hôpital Lariboisière AP-HP — Paris, France (RECRUITING)
• Hôpital Saint Antoine AP-HP — Paris, France (RECRUITING)
• Hôpital Tenon AP-HP — Paris, France (RECRUITING)
• La Pitié Salpetriere hospital — Paris, France (RECRUITING)
• CHU Bordeaux- GHU SUD hôpital Haut-Lévêque — Pessac, France (RECRUITING)
• CHU DE ROUEN, Hôpital CHARLES NICOLLE — Rouen, France (RECRUITING)

Study contacts

• Study coordinator: David Saadoun, MD PhD

Conditions: Behcet Syndrome