2023-510262-27-00招募中2 期
Randomized controlled multicenter study comparing steroid therapy plus anticoagulants to steroid therapy alone in deep venous thrombosis of Behçet’s syndrome. AntiCoagulation in Treatment Of thRombosis in Behçet's syndrome (ACTOR).
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 10
- 主要终点
- Rate of success defined as absence of deep venous thrombosis relapse and major bleeding event, without introduction of additional immunosuppressive medication for BS venous activity at 6 months and following the glucocorticoids tapering.
研究概览
简要总结
Assess efficacy and safety of prednisone therapy plus anticoagulant versus prednisone alone (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market) in reducing rate of relapse of deep venous thrombosis related to BS without major bleeding.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
排除标准
- •Clinical condition, other than venous thrombosis, requiring anticoagulation (e.g. atrial fibrillation…).
- •Active bleeding or high risk for bleeding contraindicating treatment with anticoagulants
- •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
- •Severe 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
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Rate of success defined as absence of deep venous thrombosis relapse and major bleeding event, without introduction of additional immunosuppressive medication for BS venous activity at 6 months and following the glucocorticoids tapering.
Rate of success defined as absence of deep venous thrombosis relapse and major bleeding event, without introduction of additional immunosuppressive medication for BS venous activity at 6 months and following the glucocorticoids tapering.
次要结局
- Cumulative incidence of deep venous thrombosis and superficial venous thrombosis relapse within 12 months from randomization
- Cumulative incidence of major venous thrombosis (i.e other than limbs) relapse within 12 months from randomization
- Cumulative incidence of venous repermeabilization, assessed by vascular imaging at 6 months. The following ultrasound criteria will be used to determine the absence of repermeabilization flow: partial compressibility of the vein, diminution of the vessel diameter, heterogeneous and hyperechoic thrombus, multiple channels of flow inside the veins, reflux, and collateral circulation.
- Femoral and popliteal vein reflux is defined as retrograde flow > 1 s after calf and thigh compression release while the patient was in the standing position
- Measures of corticosteroid sparing: Proportion of patients with a dose ≤ 5 mg/day of prednisone at 6, and 12 months. (prednisone or equivalent prednisone dose only if prednisone is out of stock in the market). Dose at 3, 6 and 12 months. Cumulative dose at 3, 6, and 12 months
- Cumulative incidence of major bleeding event within 12 months from randomization
- Cumulative incidence of bleeding event within 12 months from randomization
- Adverse events (counts, proportions) at 3, 6, and 12 months
- Change in SF-36 quality-of-life at 3, 6, and 12 months, from baseline
- Change in Behçet's Disease activity scores BDCAF, BSAS and Physician Global Assessment (PhGA) at 3, 6, and 12 months
- Overall Survival and event-free-survival within 12 months from randomization
- Proportion of post thrombotic syndrome according to Villalta’s post-thrombotic syndrome scale and mean changes in Villalta’s post-thrombotic syndrome scale at 6, and 12 months
- Proportion of remission according to other organs involved at 3, 6, and 12 months
- Changes in acute-phase reactants at 1, 3, 6, and 12 months
研究者
stanislas quenard
Scientific
Assistance Publique Hopitaux De Paris
研究点 (10)
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