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Taking peoplePhase 3

Steroids with or without a blood thinner for leg vein clots in Behçet's syndrome

Tests rivaroxaban added to steroids for Behçet's syndrome vein clots.

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
France17 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
Status
Recruiting
Phase
Phase 3
People taking part
134 people, planned
Started
24 Jun 2025
Expected to end
24 Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Corticosteroids + Rivaroxaban
  • Corticosteroids alone
Record updated
23 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Behçet's syndrome who have a blood clot in a deep vein (deep venous thrombosis). It compares steroids plus the blood thinner Rivaroxaban with steroids alone.

Age
18 years and older
Sex
All sexes
Disease stage
Behçet's syndrome by the international criteria, with a first or repeat deep vein clot seen on imaging (ultrasound, Angio CT scan or angio MRI).
Earlier treatment
People cannot join if they took blood thinners for more than 4 weeks before joining. They also cannot join if they took more than 20 mg prednisone equivalent daily for more than 6 weeks in a row, or more than 4000 mg methylprednisolone in the 4 weeks before. Their biologic or immunosuppressant dose must not have changed in the month before joining.

Main reasons for not taking part

  • Another condition that needs blood thinners, such as atrial fibrillation
  • Active bleeding or high bleeding risk
  • Only a surface vein clot, with no deep vein clot
  • Pregnancy or breastfeeding
  • Severe kidney disease (creatinine clearance <30ml/min/1,73m2), liver failure with clotting problems, or platelet count < 50 x 103/mm3

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
  • Isolated superficial thrombosis without concomitant deep venous thrombosis
  • 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
  • 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
  • Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…)
  • Severe chronic renal (creatinine clearance <30ml/min/1,73m2) or liver insufficiency associated with coagulopathy
  • Platelet count < 50 x 103/mm3
  • Pregnancy or lactation

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Corticosteroids and RivaroxabanTreatment being tested

    Treatment: Corticosteroids + Rivaroxaban

  • Corticosteroids aloneExisting treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome
Plain-language title
Steroids with or without a blood thinner for leg vein clots in Behçet's syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
23 April 2026