NCT00720915已完成不适用
A Cohort Study to Test That There is a Low Risk of Recurrent VTE in Patients With a First Episode of Unprovoked VTE Who Stop Anticoagulant Therapy After 3 Months of Treatment in Response to Negative D-dimer Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 25
- 主要终点
- Suspected Recurrent DVT
研究概览
简要总结
The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be >= 18 years of age
- •Have had ONE episode of unprovoked proximal DVT and/or PE
- •Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)
排除标准
- •Another indication for long-term anticoagulation (e.g., atrial fibrillation)
- •A high risk of bleeding as evidenced by any of the following:
- •Age greater than 75 years
- •Previous episode of major bleeding where the cause was not effectively treated
- •Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L
- •Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl)
- •Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl)
- •Active peptic ulcer disease
- •Poor compliance with, or control of, anticoagulant therapy during initial treatment
- •Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel)
- •A vena caval filter
- •Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed
- •Has a life expectancy less than 5 years
- •Is unable to attend follow-up visits because of geographic inaccessibility
- •Is participating in a competing clinical investigation
结局指标
主要结局
Suspected Recurrent DVT
时间窗: up to 7 years
Suspected (recurrent) pulmonary embolism
时间窗: up to 7 years
Bleeding
时间窗: up to 7 years
Death
时间窗: up to 7 years
次要结局
未报告次要终点
研究者
研究点 (25)
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