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NCT Number: NCT06780462

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

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.

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Key information

Conditions

Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Mouth Diseases Panuveitis Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU BORDEAUX Hôpital Saint-André, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroids + Rivaroxaban

Drug

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

Corticosteroids alone

Drug

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

Primary outcomes

  1. Rate of success

    Time frame: At 6 months

    Defined as absence of deep venous thrombosis relapse and of major bleeding event, without introduction of additional immunosuppressive medication for BS activity other than thrombotic events at 6 months.

Secondary outcomes

  1. Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse

    Time frame: At 12 months

  2. Cumulative incidence of major venous thrombosis

    Time frame: At 12 months

    pulmonary embolism, vena cava , Budd Chiari syndrome , intra-cardiac relapse

  3. Cumulative incidence of venous repermeabilization

    Time frame: At 6 months

    assessed by vascular imaging

  4. Proportion of patients with a dose ≤ 5 mg/day of prednisone

    Time frame: At 6 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  5. Proportion of patients with a dose ≤ 5 mg/day of prednisone

    Time frame: At 12 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  6. Dose of prednisone

    Time frame: At 3 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  7. Dose of prednisone

    Time frame: At 6 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  8. Dose of prednisone

    Time frame: At 12 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  9. Cumulative dose of prednisone

    Time frame: At 3 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  10. Cumulative dose of prednisone

    Time frame: At 6 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  11. Cumulative dose of prednisone

    Time frame: At 12 months

    (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market)

  12. Cumulative incidence of major bleeding event

    Time frame: At 12 months

  13. Cumulative incidence of bleeding event

    Time frame: At 12 months

  14. Number of adverse events

    Time frame: At 3 months

  15. Number of adverse events

    Time frame: At 6 months

  16. Number of adverse events

    Time frame: At 12 months

  17. Change in SF-36 quality-of-life

    Time frame: At 3 months

    The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.

  18. Change in SF-36 quality-of-life

    Time frame: At 6 months

    The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.

  19. Change in SF-36 quality-of-life

    Time frame: At 12 months

    The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.

  20. Change in Behçet's Disease Current Activity Form

    Time frame: At 3 months

    It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease.

  21. Change in Behçet's Disease Current Activity Form

    Time frame: At 6 months

    It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease.

  22. Change in Behçet's Disease Current Activity Form

    Time frame: At 12 months

    It is a 7 items score ranging from 0 to 12. The higher the sore the higher the severity of the disease.

  23. Change in Behçet's Syndrome Assessment Score

    Time frame: At 3 months

    It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease.

  24. Change in Behçet's Syndrome Assessment Score

    Time frame: At 6 months

    It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease.

  25. Change in Behçet's Syndrome Assessment Score

    Time frame: At 12 months

    It is based on various clinical manifestations of Behçet's disease. Score ranges from 0 to 12. The higher the score the higher the severity of the disease.

  26. Change in Physician Global Assessment

    Time frame: At 3 months

    Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease.

  27. Change in Physician Global Assessment

    Time frame: At 6 months

    Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease.

  28. Change in Physician Global Assessment

    Time frame: At 12 months

    Evaluation of the disease activity. It ranges from 0 to 10. The higher the score the higher the activity of the disease.

  29. Overall survival

    Time frame: At 12 months

  30. Event free survival

    Time frame: At 12 months

  31. Proportion of post thrombotic syndrome

    Time frame: At 12 months

    According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms

  32. Changes in Villalta's post-thrombotic syndrome scale

    Time frame: At 6 months

    According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms

  33. Changes in Villalta's post-thrombotic syndrome scale

    Time frame: At 12 months

    According to Villalta's post-thrombotic syndrome scale. It assesses the prensece and severity of post thrombotic syndrome. The score ranges from 0 to 30. The higher the score the more severe are the symptoms

  34. Proportion of remission

    Time frame: At 3 months

    According to other organs involved

  35. Proportion of remission

    Time frame: At 6 months

    According to other organs involved

  36. Proportion of remission

    Time frame: At 12 months

    According to other organs involved

  37. Changes in acute-phase reactants

    Time frame: At 1 month

  38. Changes in acute-phase reactants

    Time frame: At 3 months

  39. Changes in acute-phase reactants

    Time frame: At 6 months

  40. Changes in acute-phase reactants

    Time frame: At 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

David Saadoun, MD PhD

CONTACT

[email protected]

0142178042 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

0142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ACTOR

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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