Safety and efficacy of a D-Dimer-guided strategy for extension of secondary prophylaxis of venous thromboembolism - a prospective and randomized management trial

D-二聚体引导策略延长静脉血栓栓塞二级预防的安全性和有效性 - 一项前瞻性随机管理试验

• 批准号: 34774826
• 负责人: Professor Dr. Bernd Pötzsch
• 金额: --
• 依托单位: Kerckhoff-Klinik GmbH
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2007
• 资助国家: 德国
• 起止时间: 2006-12-31 至 2010-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/34774826?language=en
• 关键词: Safety; efficacy; Dimer; guided; strategy

After a first episode of acute deep venous thrombosis (DVT) the risk of recurrence is relatively high and clinical consequences are important. Therefore, secondary prophylaxis using oral anticoagulant treatment (OAT) is usually established in these patients. This treatment very effectively reduces the risk of recurrences but induces an increased risk of bleeding. Major bleeding complications can be expected in »2% patient-years. Therefore, current recommendations limit OAT to a period of 3 to 12 months. After stopping of OAT, however, »10 % of patients with an initial episode of unprovoked DVT will develop a recurrent event within 1 year. This group of patients may benefit from prolonged OAT. The results of 2 independent observational studies showed a significantly higher risk of recurrence in patients showing increased levels of D-Dimer after withdrawal of OAT. D-Dimer is a biomarker that indicates fibrin formation followed by fibrinolysis. Based on these data we hypothesize that D-Dimer testing can be successfully used to tailor the duration of OAT in patients after an unprovoked episode of DVT. This clinical trial will investigate this hypothesis using a prospective, randomized, and controlled design. Approximately 300 patients showing increased D-Dimer (> 500 ng/ml) after withdrawal of OAT will be randomly assigned to a treatment and a non-treatment group. During a 24-months lasting treatment period the rates of objectively documented DVT/pulmonary embolism (primary efficacy endpoint) and of hemorrhages (primary safety endpoint) will be documented. A 12-months lasting follow up period will show whether a catch-up phenomenon occurs after stopping of extended OAT. The results will show if D-Dimer-based treatment algorithms can be implemented into clinical practice.

急性深静脉血栓形成（DVT）首次发作后，复发的风险相对较高，临床后果很重要。因此，通常在这些患者中建立口服抗凝剂治疗（OAT）的二级预防。这种治疗非常有效地降低了复发的风险，但会增加出血的风险。预计大出血并发症发生率> 2%患者年。因此，目前的建议将审裁处的期限限制在3至12个月。然而，在停止OAT后，> 10%的无端DVT首次发作的患者将在1年内发生复发事件。这组患者可能从延长OAT中获益。2项独立观察性研究的结果显示，停用OAT后D-二聚体水平升高的患者复发风险显著升高。D-二聚体是指示纤维蛋白形成随后纤维蛋白溶解的生物标志物。基于这些数据，我们假设D-二聚体检测可成功用于调整患者在无端DVT发作后的OAT持续时间。本临床试验将采用前瞻性、随机和对照设计研究这一假设。将大约300名在停用OAT后显示D-二聚体增加（> 500 ng/ml）的患者随机分配至治疗组和非治疗组。在24个月的持续治疗期间，将记录客观记录的DVT/肺栓塞（主要疗效终点）和肺栓塞（主要安全性终点）的发生率。为期12个月的随访期将显示在停止延长的OAT后是否出现追赶现象。结果将显示基于D-二聚体的治疗算法是否可以应用于临床实践。