Mesoglycan (Prisma®) Versus Placebo in Secondary Prevention of the Superficial Venous Thrombosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Cumulative thrombosis recurrence
研究概览
简要总结
The objective of the study is to demonstrate the superiority of the mesoglycan (Prisma®), compared to placebo, in reducing the incidence of thromboembolic complications (relapse / extension of superficial venous thrombosis (SVT), deep venous thrombosis (DVT), pulmonary embolism (PE)) in patients who have completed the cycle of therapy of the acute phase after superficial vein thrombosis.
详细描述
Rationale: SVT is a relatively common clinical condition, with recent evidence of association with the development of DVT and / or pulmonary embolism that has changed the perception of the risk of this disease (with conflicting data in the literature: 3-33 %). Previous natural history studies have observed that thromboembolic complications (relapse / extension of SVT, DVT, PE) can affect up to 10-15% of subjects at 3-6 months from the initial event, despite adequate treatment of the acute phase. There are no literature studies that have prospectively investigated the usefulness of drug therapy in secondary prevention of SVT once the initial therapeutic cycle is completed.
Objective: To demonstrate the superiority of the mesoglycan (Prisma®), compared to placebo, in reducing the incidence of thromboembolic complications (relapse / extension of superficial venous thrombosis (SVT), deep venous thrombosis (DVT), pulmonary embolism (PE)) in patients who have completed the cycle of therapy of the acute phase after superficial vein thrombosis.
Investigators: 18 Italian centers with proven experience in the treatment and prevention of venous thromboembolic disease.
Study Design:
Phase II, multicentre, randomized, double-blind superiority study comparing mesoglycan (Prisma®) 50 mg and placebo, both in double oral daily intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both genders, aged> = 18 years,
- •With previous diagnosis of SVT of the lower limbs documented by color-coded duplex ultrasonography (CCDU), which at the onset was at least 5 cm of extension and at least 3 cm from the saphenous junctions (vena magna saphenous and saphenous),
- •who have completed the initial therapeutic cycle with Fondaparinux 2.5 mg / day for 45 days, as required by the most recent Guidelines (ACCP).
- •That screening CCDU does not show deep venous involvement, or an extension of the initial SVT.
排除标准
- •Poor compliance with the treatment of SVT,
- •life expectancy <24 months,
- •anticipated lack of cooperation or impossibility to complete the questionnaires,
- •pregnancy, lactation or programmed pregnancy during the duration of the study,
- •severe locomotor disability or prolonged immobilization,
- •participation in another study in the last 3 months,
- •post-thrombotic syndrome with "Villalta score"> 4,
- •chronic lymphedema of the lower limbs,
- •recent (<3 months) or planned interventional drip-surgery or trans-luminary arterial percutaneous angioplasty (PTA),
- •ongoing dialysis treatment,
- •malabsorption / malnutrition status,
- •chronic and non-suspendable use of anticoagulants, phlebotropics, corticosteroids or NSAIDs, double-antiaggregation or ASA> 160mg / die, centrally acting painkillers,
- •subjects with hypersensitivity to the mesoglycan, heparin or heparinoids, intolerant to galactose or with lactase deficiency, carriers of hemorrhagic diathesis or diseases.
研究组 & 干预措施
Placebo Oral Tablet
Placebo comparator twice-a-day, for 12 months
干预措施: Placebo Oral Tablet (Drug)
Mesoglycan Oral Tablet
a mixture of glycosaminoglycans (mainly heparan-sulphate, dermatan sulfate), inhibitors of thrombin and of Factor Xa and active in restore flow-mediated vasodilation.
50 mg, twice-a-day, for 12 months
干预措施: Mesoglycan Oral Tablet (Drug)
结局指标
主要结局
Cumulative thrombosis recurrence
时间窗: 12 months
Cumulative occurrence of the first event, with instrumental confirmation, occurring during the study treatment between: recurrence or extension of, asymptomatic or symptomatic, SVT, new DVT (proximal asymptomatic or symptomatic / symptomatic isolated distal), pulmonary embolism (fatal or symptomatic non-fatal).
次要结局
- Symptoms(12 months)
- Cumulative thrombosis recurrence with distal(12 months)
- VEINES-QOL/ Sym score(12 months)