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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Rate of success [Срок оценки: At 6 months]

Вторичные конечные точки (12)

• Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse [Срок оценки: At 12 months]
• Cumulative incidence of major venous thrombosis [Срок оценки: At 12 months]
• Cumulative incidence of venous repermeabilization [Срок оценки: At 6 months]
• Proportion of patients with a dose ≤ 5 mg/day of prednisone [Срок оценки: At 6 months]
• Proportion of patients with a dose ≤ 5 mg/day of prednisone [Срок оценки: At 12 months]
• Dose of prednisone [Срок оценки: At 3 months]
• Dose of prednisone [Срок оценки: At 6 months]
• Dose of prednisone [Срок оценки: At 12 months]
• Cumulative dose of prednisone [Срок оценки: At 3 months]
• Cumulative dose of prednisone [Срок оценки: At 6 months]
• Cumulative dose of prednisone [Срок оценки: At 12 months]
• Cumulative incidence of major bleeding event [Срок оценки: At 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 17 центров

• CHU BORDEAUX Hôpital Saint-André — Bordeaux
• Ambroise Paré hospital AP-HP — Boulogne-Billancourt
• CHU Caen — Caen
• Hopital Henri Mondor AP-HP — Créteil
• Chu de Grenoble — Grenoble
• Hôpital Bicêtre — Le Kremlin-Bicêtre
• Hcl, Hopital de La Croix Rousse — Lyon
• Centre Hospitalier de Melun — Melun
• … и ещё 9 центров

Идентификаторы

NCT: NCT06780462 · APHP220673

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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