SECONDARY PREVENTION TRIAL OF VENOUS THROMBOSIS-DCC

静脉血栓栓塞性疾病（VTE）与超过30万例 住院治疗，每年导致数千人死亡。 尽管 问题的严重性，病人的最佳管理 首次出现深静脉血栓尚不清楚。 当前治疗 包括华法林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发病率有关。 一旦治疗停止，复发。 此外，遵守情况不佳 继发于频繁的实验室监测和出血并发症 限制了这种治疗方案的整体效果。 现时 没有临床方案已被证明具有可接受的 风险/效益比，以支持长期预防。这似乎是真的 对于高风险患者（因子V Leiden突变）以及 一般人口。 本提案的主要目的是评估3至 4年低剂量华法林（1.5-2.0）的二级预防 特发性静脉血栓栓塞 该提案旨在评估 有和没有凝血因子V莱顿患者。拟议的审判是一个 随机双盲、安慰剂对照试验，为期3至4年， 低剂量华法林抗凝治疗预防复发 深静脉血栓该研究将招募800名患者。 招生 旨在确保300名凝血因子V患者的参与 莱顿 将从25家临床试验机构入组患者。 40岁的男女 已完成标准治疗的记录在案的特发性VTE患者年 将被随机分配至常规治疗加安慰剂组或常规治疗加3- 低剂量华法令的年方案。 滴定后，方案 将需要不频繁的实验室监测。 试验终点包括 复发性静脉血栓形成、大出血和全因死亡率 将该组作为一个整体或因子V Leiden突变亚组。 事件将 通过每年一次的访问和每两个月一次的问卷调查进行评估， INR监测。

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.