Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,455
- 试验地点
- 1
- 主要终点
- Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
研究概览
简要总结
The study aims at optimizing extended management of elderly patients (> 75 years) with at least one of the known bleeding risk factor, who suffered from first episode of venous thromboembolism of the lower extremity (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients were randomized to receive three different treatment: Sulodexide 250 mg BIS in die; Sulodexide 500 BID in die or indistinguishable placebo to verify the efficacy and safety of extended treatment for 12 months with Sulodexide (Vessel®) in the secondary prevention of Deep Vein Thrombosis / Pulmonary Embolism (DVT/PE) recurrence.
详细描述
This prospective cohort study aims to assess the efficacy and safety of the extended treatment with Sulodexide (Vessel®) in the secondary prevention of DVT / PE recurrence in elderly outpatients (≥ 75 years old at the time of inclusion) ), with at least one of the known bleeding risk factor, who had a first episode of lower extremity proximal DVT and / or PE, idiopathic or associated with weak or removed risk factors, and who have received standard treatment with any oral anticoagulant drug lasting at least 3 months. The study seeks to verify the safety of the Sulodexide therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not > 3%).
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)
盲法说明
The subjects enrolled in the study, the experimenters, and the members of the Steering Committee, Adjudication Committee, Data Monitoring and Safety Board will not be aware of the assignment of the 3 treatments following their distribution.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a first event of proximal lower extremity DVT and / or PE, idiopathic or associated with weak or removed risk factors.
- •Patients aged ≥75 years at the time of enrolment
- •Patients with at least one of the known risk factors of bleeding (APPENDIX 1):
- •Hypertension
- •Renal failure
- •Thrombocytopenia
- •Antiplatelet therapy (ASA maximum 140 mg/die)
- •Frequent falls (>2 /years)
- •Nonsteroidal anti-inflammatory drug
- •Liver failure
- •Previous Stroke
- •Poor anticoagulant control
- •Alcohol abuse
- •Patients of both sexes.
- •Patients who at the time of enrolment have already undergone a period of anticoagulant therapy (AT, with any medication) of at least 3 months and the therapy has not been suspended for more than 30 days.
- •Patients with no other AT indications.
- •Patients capable and able to provide informed consent
排除标准
- •Patients aged <75 years at the time of the recruitment visit.
- •"Provoked" index event, which occurred:
- •Within 3 months of surgery or major trauma,
- •Bed Rest > 4 days,
- •Cast / immobility within 3 months.
- •Index event represented by severe PE, with life threatening risk or treated with thrombolytic therapy.
- •Index event represented by isolated distal DVT or superficial venous thrombosis.
- •Thrombotic event in sites other than the deep proximal veins of the lower limbs.
- •Anticoagulant therapy for less than 3 months at the time of enrolment.
- •Discontinuation of anticoagulant therapy for over thirty days at the time of enrolment
- •Recurrent episodes of DVT ± PE
研究组 & 干预措施
Treatment A
Sulodexide (Vessel) 2 capsules of 250 LSU BID, for 12 months
干预措施: Sulodexide (Drug)
Treatment B
Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months
干预措施: Sulodexide and placebo (Drug)
Treatment B
Sulodexide (Vessel) 1 capsule of 250 LSU and 1 indistinguishable placebo capsule BID., for 12 months
干预措施: Placebo (Drug)
Treatment C
2 indistinguishable placebo capsules BID, for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy).
时间窗: From date of enrollment until the date of first documented event assessed up to 12 months
The occurrence of proximal deep vein thrombosis with or without pulmonary embolism (new or recurrent episode) wil be recorded in all patients
Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety)
时间窗: From date of enrollment until the date of first documented event assessed up to 12 months
Fatal bleeding; intracranial; intraspinal; intraocular; pericardial; intra-articular; intramuscular with compartment syndrome; retroperitoneal,; acute clinically overt bleeding will be recorded in all patients
次要结局
- Number of and rate of thromboembolic events(From date of enrollment until the date of first documented event assessed up to 12 months)
- Number and rate of non major bleeding complications(From date of enrollment until the date of first documented event assessed up to 12 months)
- Number and rate of dead patients (overall mortality)(From date of enrollment until the date of first documented event assessed up to 12 months)
- Presence of severe post-thrombotic syndrome according to Villalta Score(12 months)