Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis (IDENT): a Prospective, Multicenter, Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- Radiographically confirmed recurrent venous thromboembolism
研究概览
简要总结
The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute IDDVT. However, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. Thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic IDDVT of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.
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
- Triple (Participant, 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
- •Patients aged 18-90
- •Outpatients with a first, acute (within 2 weeks), symptomatic, objectively confirmed isolated distal DVT
- •Compliance to the scheduled follow up plan
- •Ability and willing to participate and sign the informed consent.
排除标准
- •Any absolute contraindication to anticoagulant treatment
- •Pregnancy or breast-feeding
- •Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg
- •Platelet count < 100 × 10⁹ /L
- •Serum creatinine > 180 mmol/L or creatinine clearance ≤30 ml/min
- •Liver disease associated with coagulopathy and high risk of bleeding
- •Clinically suspected or confirmed pulmonary embolism
- •Ipsilateral or contralateral proximal DVT
- •Any indication for long-term anticoagulation
- •Enrolled in another clinical trial simultaneously
- •Life expectancy < 6 months
研究组 & 干预措施
Prophylactic Anticoagulation
Rivaroxaban 10 mg od for 3 months
干预措施: Rivaroxaban (Drug)
Therapeutic Anticoagulation
Rivaroxaban 20 mg od for 3 months
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Radiographically confirmed recurrent venous thromboembolism
时间窗: 6 months
Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.
Major or clinically relevant non-major bleeding events
时间窗: 3 months
Major bleeding events are defined according to the International Society on Thrombosis and Haemostasis criteria. Clinically relevant non-major bleeding events refer to which do not meet the mentioned criteria of major bleeding but need at least an unscheduled in-person consultant.
次要结局
- Residual vein occlusion(6 months)
- Post-thrombotic syndrome(6 months)
- Individual component of primary outcomes (e.g. proximal extension, major bleeding)(6 months)
- All-cause death(6 months)