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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: David Saadoun, MD PhD
• Email: david.saadoun@psl.aphp.fr
• Phone: 0142178042

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.