Tamura Yuichi, Iwasa Takeshi, Kumamaru Hiraku, Miyata Hiroaki, Mukai Mikio, Shigematsu Kunihiro, Shoji Masaaki, Tanabe Nobuhiro, Yamada Norikazu, Yasuda Chikao, Miyata Tetsuro
Department of Cardiology, International University of Health and Welfare School of Medicine, Mita Hospital Tokyo Japan.
International University of Health and Welfare School of Medicine Narita Japan.
Circ Rep. 2019 Nov 1;1(11):534-537. doi: 10.1253/circrep.CR-19-0078.
The incidence of thromboembolism in patients with cancer is approximately 11%, and the risk of thrombosis in patients with malignant tumors is 6-fold higher than that in healthy persons. Thrombosis not only disrupts the treatment of cancer but also induces deterioration of quality of life (QOL). Knowledge about thrombus treatment is limited, and evidence is scarce. Clarification of the status and safety of venous thromboembolism (VTE) treatment in patients with cancer will contribute to active intervention and improvement of prognosis and QOL. In this study, the therapeutic effects of a non-vitamin K antagonist oral anticoagulant for VTE and the prognosis of cancer after treatment will be examined to establish a therapeutic method for VTE in patients with cancer. A multicenter, non-interventional, observational study will be conducted in patients with cancer who developed VTE and underwent anticoagulant therapy with rivaroxaban (group A) or warfarin (group B) for 24 weeks. The primary endpoint will be the recurrence/aggravation of symptomatic VTE or occurrence/aggravation of deep vein thrombosis. Registration of 500 patients is needed in order to calculate the 95% confidence interval of the event rate at ±1% precision. The investigation period will run from January 2019 to December 2023 with ongoing selection of patients. Trial registration: no. 5-18-32 (approved 1 August 2018).
癌症患者血栓栓塞的发生率约为11%，恶性肿瘤患者发生血栓形成的风险比健康人高6倍。血栓形成不仅会干扰癌症治疗，还会导致生活质量（QOL）下降。关于血栓治疗的知识有限，证据也很少。阐明癌症患者静脉血栓栓塞（VTE）治疗的现状和安全性将有助于积极干预并改善预后和生活质量。在本研究中，将研究一种非维生素K拮抗剂口服抗凝剂对VTE的治疗效果以及治疗后癌症的预后，以建立癌症患者VTE的治疗方法。将对发生VTE并接受利伐沙班（A组）或华法林（B组）抗凝治疗24周的癌症患者进行一项多中心、非干预性观察研究。主要终点将是有症状VTE的复发/加重或深静脉血栓形成的发生/加重。为了以±1%的精度计算事件发生率的95%置信区间，需要登记500名患者。调查期将从2019年1月持续到2023年12月，患者选择工作正在进行中。试验注册号：5-18-32（2018年8月1日批准）。
