Direct oral anticoagulants may be effective and safe for treatment of venous thromboembolism (VTE) in cancer patients, but they have not been compared with low-molecular-weight heparin (LMWH), the current recommended treatment for these patients. The Hokusai VTE-cancer study is a randomised, open-label, clinical trial to evaluate whether edoxaban, an oral factor Xa inhibitor, is non-inferior to LMWH for treatment of VTE in patients with cancer. We present the rationale and some design features of the study. One such feature is the composite primary outcome of recurrent VTE and major bleeding during a 12-month study period. These two complications occur frequently in cancer patients receiving anticoagulant treatment and have a significant impact. The evaluation beyond six months will fill the current gap in the evidence base for the long-term treatment of these patients. Based on the observation that the risk of recurrent VTE in patients with active cancer is similar to that in those with a history of cancer, the Hokusai VTE-cancer study will enrol patients if whose cancer was diagnosed within the past two years. In addition, patients with incidental VTE are eligible because their risk of recurrent VTE is similar to that in patients with symptomatic disease. The unique design features of the Hokusai VTE-cancer study should lead to enrolment of a broad spectrum of cancer patients with VTE who could benefit from oral anticoagulant treatment.

译文

:直接口服抗凝剂对癌症患者的静脉血栓栓塞(VTE)可能是有效和安全的,但尚未与低分子量肝素(LMWH)(目前推荐用于这些患者)进行比较。 Hokusai VTE癌症研究是一项随机,开放标签的临床试验,旨在评估口服Xa因子抑制剂edoxaban是否不逊于LMWH治疗癌症患者的VTE。我们介绍了这项研究的基本原理和一些设计特征。这样的特征之一是在12个月的研究期间内,复发性VTE和主要出血的复合主要预后。这两种并发症在接受抗凝治疗的癌症患者中经常发生,并产生重大影响。超过六个月的评估将填补这些患者长期治疗的证据基础中的空白。基于观察到活动性癌症患者复发VTE的风险与有癌症史的患者相似,如果在过去两年内诊断出癌症,Hokusai VTE癌症研究将招募患者。此外,患有偶然性VTE的患者符合资格,因为其复发性VTE的风险与有症状疾病的患者相似。 Hokusai VTE癌症研究的独特设计特征应可招募可从口服抗凝治疗中受益的众多VTE癌症患者。

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