SECONDARY PREVENTION TRIAL OF VENOUS THROMBOSIS-DCC

静脉血栓栓塞症(VTE)与30多万人有关 每年有数千人因住院而死亡。尽管 问题的严重性，患者的最佳管理 首次发生深静脉血栓形成尚不清楚。目前的治疗方法 包括使用华法林的短期、全剂量口服抗血栓治疗。 不幸的是，这种治疗与非常高的 一旦治疗停止就会复发。此外，合规性差 继发于频繁的实验室监测和出血并发症 限制这种治疗方案的整体效果。目前，在那里 是否没有已被证明具有可接受的临床方案 支持长期预防的风险/收益比率。这似乎是真的 对于高危患者(因子V莱顿突变)以及 普通人口。 这项建议的主要目标是评估3%至 4年小剂量华法林(1.5-2.0)在慢性阻塞性肺疾病二级预防中的应用 特发性静脉血栓栓塞症。该提案旨在评估 伴有和不伴有因子V莱顿的患者。拟议的审判是一项 随机、双盲、安慰剂对照、为期3至4年的试验 小剂量华法林抗凝治疗预防复发 深静脉血栓形成。这项研究将招募800名患者。招生 旨在确保300名V因子患者参与 莱顿。 患者将从25个临床地点招募。40岁的男性和女性 已完成标准治疗的特发性静脉血栓栓塞症患者数年 将被随机分为常规护理加安慰剂或常规护理加3- 一年的低剂量华法林疗法。滴定后，该方案 将不需要频繁的实验室监测。试验终端包括 反复的静脉血栓形成，大出血，以及所有这些都会导致死亡 该组作为一个整体或因子V Leiden突变亚组。活动将 通过每年一次的访问和当时的双月问卷进行评估 INR监测的结果。

Venous thromboembolic disease (VTE) is associated with more than 300,000 hospitalizations and results in thousands of deaths annually. Despite the magnitude of the problem, optimal management of patients experiencing first deep vein thrombosis is unclear. Current treatment includes short-term full dose oral antithrombotic therapy with warfarin. Unfortunately, this treatment is associated with a very high rate of recurrence once therapy is stopped. In addition, poor compliance secondary to frequent laboratory monitoring and bleeding complications limit this treatment regimen's overall effectiveness. Presently, there is no clinical regimen which has been proven to have an acceptable risk/benefit ratio to support long-term prophylaxis. This appears true for high risk patients (factor V Leiden mutation) as well as for the general population. The primary aim of this proposal is to assess the net benefit of 3 to 4 years of low-dose warfarin (1.5-2.0) in the secondary prevention of idiopathic venous thromboembolism. The proposal is designed to evaluate patients with and without factor V Leiden. The proposed trial is a randomized double-blind, placebo-controlled trial of 3 to 4 years of anticoagulant therapy with low-dose warfarin prevention of recurrent deep vein thrombosis. The study will enroll 800 patients. Enrollment is designed to ensure participation of 300 patients with factor V Leiden. Patients will be enrolled from 25 clinical sites. Men and women of 40 years with documented idiopathic VTE who have finished standard therapy will be randomized to usual care plus placebo or usual care plus a 3- year regimen of low-dose warfarin. Following titration, the protocol will require infrequent laboratory monitoring. Trial endpoints include recurrent venous thrombosis, major bleeding, and all cause mortality for the group as a whole or factor V Leiden mutation subgroup. Events will be assessed by yearly visits and bi-monthly questionnaires at the time of the INR monitoring.