Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 605
- 试验地点
- 1
- 主要终点
- Symptomatic VTE recurrence event or VTE related death event
研究概览
简要总结
The purpose of this study is to determine the optimal duration of anticoagulation therapy (3 months versus 12 months) with direct oral anticoagulant (edoxaban) for isolated distal deep vein thrombosis.
详细描述
Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), is a major health problem in the world. There have been many clinical studies evaluating PE and/or proximal DVT, although data on isolated distal DVT (IDDVT) has been quite limited. However, IDDVT was reported to account for about half of all the diagnoses of DVT detected on ultrasound in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. The current American College of Chest Physicians (ACCP) guidelines suggest the same approach for IDDVT patients with cancer as proximal DVT patients with cancer. However, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. Recently, some observational studies reported that IDDVT patients with cancer have a high risk of VTE recurrence, suggesting the benefit of prolonged anticoagulation therapy. In this open-label, superiority trial, we will randomly assign IDDVT patients with active cancer to receive either edoxaban for 3 months (short DOAC group) or edoxaban for 12 months (long DOAC group).
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly found isolated distal deep vein thrombosis
- •Patients complicated with active cancer
- •Patients who are scheduled to be treated by anticoagulation therapy.
排除标准
- •Patients with anticoagulation therapy for the index event before 10 days of allocation.
- •Patient under anticoagulation therapy for the purpose of other than the index event.
- •Patients with thrombolysis therapy or IVC filter at the Index event.
- •Patients with creatinine clearance less than 30 ml/min.
- •Patients who are expected to have a life prognosis of 3 months or less.
- •Patients with pulmonary embolism.
- •Patients who are not appropriate for the participation of the study.
研究组 & 干预措施
12-month Edoxaban
Edoxaban for 12 months
干预措施: 12-month Edoxaban (Drug)
3-month Edoxaban
Edoxaban for 3 months
干预措施: 3-month Edoxaban (Drug)
结局指标
主要结局
Symptomatic VTE recurrence event or VTE related death event
时间窗: 12 months
Symptomatic VTE recurrence event is defined as PE and/or DVT with symptoms accompanied by confirmation of new thrombus or exacerbation of the thrombus by objective imaging examinations or autopsy. VTE related death event is defined as death due to a documented PE (either an objective test prior to death of the subject or PE detected during autopsy) or unexplained death (i.e. death without a clear alternate cause and not a primary consequence of subject's underlying cancer.)
次要结局
- All-cause death(12 months)
- Symptomatic VTE recurrence event(12 months)
- Clinically relevant bleeding(12 months)
- Unsuspected recurrent VTE by any imaging examinations(12 months)
- Major bleeding event (ISTH criteria)(12 months)
- VTE related death event(12 months)
- Clinically relevant non-major (CRNM) bleeding(12 months)
- Bleeding related death event(12 months)
- Unsuspected recurrent DVT by follow-up ultrasound examinations(12 months)
- Change of serum D-dimer levels during follow-up period(12 months)
- Any adverse outcomes during invasive procedures(12 months)
研究者
Takeshi Morimoto
Professor of Medicine
Kyoto University, Graduate School of Medicine