The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score
研究概览
简要总结
The randomized clinical study aimed to assess the efficacy and safety of standard anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.
详细描述
Deep vein thrombosis is an acute inflammatory disease that affects vein wall and leads to the structural changes in the wall and valves reflected with chronic venous insufficiency that called postthrombotic syndrome (PTS).
Diosmin as a flavonoid agent has properties to reduce leukocyte-endothelial interaction and inflammatory response, that could reduce the damage to venous wall and valves.
The hypothesis of the study is based on assumption that diosmin combined with standard anticoagulation can improve outcomes of femoro-popliteal DVT due to increase speed of veins recanalization, decrease of vein wall inflammation and finally decrease the incidence of PTS at 6 month and 1 year after index DVT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor does not involve in randomisation and treatment process, has no information about the patient's belonging to one of the study groups
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •The first episode of femoro-popliteal deep vein thrombosis (DVT)
- •Verification of DVT by duplex ultrasound
- •Informed consent signed
排除标准
- •Suspicion of pulmonary embolism (PE)
- •Verified PE
- •Bilateral DVT
- •Contraindications for rivaroxaban (in accordance with the official instructions)
- •Contraindications for diosmin (in accordance with the official instructions)
- •Active cancer
- •Verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins C, S, antithrombin 3)
- •Use of other anticoagulants for more than 7 days from the DVT verification
- •Impossibility of using compression stocking after 3 days from DVT verification
- •Performed surgical intervention on the superficial or deep veins of the lower extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior cava filter)
- •Continuous use of other drugs that affect the hemostasis system (except for acetylsalicylic acid in a dose of not more than 100 mg).
- •Low compliance
研究组 & 干预措施
Experimental: Rivaroxaban + Diosmin + Stockings
treatment of deep vein thrombosis with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin
干预措施: Rivaroxaban (Drug)
Experimental: Rivaroxaban + Diosmin + Stockings
treatment of deep vein thrombosis with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin
干预措施: Diosmin (Drug)
Experimental: Rivaroxaban + Diosmin + Stockings
treatment of deep vein thrombosis with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin
干预措施: compression stockings (Other)
Control: Rivaroxaban + Stockings only
standard treatment of deep vein thrombosis with anticoagulation (rivaroxaban) and elastic compression stockings
干预措施: Rivaroxaban (Drug)
Control: Rivaroxaban + Stockings only
standard treatment of deep vein thrombosis with anticoagulation (rivaroxaban) and elastic compression stockings
干预措施: compression stockings (Other)
结局指标
主要结局
Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score
时间窗: 12 months
Detection of the postthrombotic syndrome (PTS) was made according to the Villalta score (a combination of 5 subjective symptoms and 6 objective signs of chronic venous disease) ranged from 0 (no signs) to 33 scores (maximal severity). PTS defined as 5 and more scores; mild PTS as 5-9 scores; moderate PTS as 10-14 scores; severe PTS as 15 and more scores.
次要结局
- Major Bleeding(12 months)
- Minor Bleeding(12 months)
- Number of Participants With Recurrent Symptomatic or Asymptomatic DVT(12 months)
- Number of Participants With Symptomatic Pulmonary Embolism(12 months)
- The Value of Venous Clinical Severity Score(12 months)
- The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items(12 months)
- Clinically Relevant Non-major Bleeding(12 months)
- Number of Participants With Full Recanalization of the Popliteal Vein(12 months)
- Extension of Residual Venous Obstruction by Marder Score(12 months)
- Adverse Events(12 months)