Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
BMJ Open. 2019 Nov 5;9(11):e031698. doi: 10.1136/bmjopen-2019-031698.
Anticoagulant therapy in patients with cancer with venous thromboembolism (VTE) increases the risk of both VTE recurrence and haemorrhagic complication. Direct oral anticoagulants (DOACs) have been shown to be effective in preventing VTE recurrence, and comparable to conventional therapy in preventing VTE recurrence in patients with advanced cancer. Rivaroxaban is a DOAC that causes thrombus regression, possibly through a profibrinolytic effect. Thrombus regression with initial treatment is essential for VTE patients. However, the thrombolytic effect of DOAC for VTE patients with cancer has not been fully examined. Therefore, in this study, we investigate the thrombolytic effect of rivaroxaban in patients with cancer who develop VTE.
This study is a single-arm, open-label, prospective interventional study. Forty patients aged from 20 to 75 years old at the time of consent who have been diagnosed with acute VTE and have active cancer are included. Patients are excluded if they have received thrombolytic therapy, have creatinine clearance of less than 30 mL/min, have expected a life expectancy of less than 6 months or have deep vein thrombosis limited to the distal lower leg. Eligible patients receive standard treatment with rivaroxaban (15 mg two times daily for 3 weeks, followed by 15 mg QD). The primary study endpoint is clot regression ratio as evaluated by contrast-enhanced CT imaging. CT imaging is obtained at baseline, 21±4 and 90±14 days after the start of rivaroxaban treatment. Secondary endpoints are the recurrence of VTE and haemorrhagic complications.
This study was approved by the institutional review board of the Kyoto Prefectural University of Medicine. Study results will be disseminated through peer-reviewed journals.UMIN000027793.
癌症合并静脉血栓栓塞症（VTE）患者的抗凝治疗会增加 VTE 复发和出血并发症的风险。直接口服抗凝剂（DOACs）已被证明能有效预防 VTE 复发，并且在预防晚期癌症患者 VTE 复发方面与传统治疗相当。利伐沙班是一种 DOAC，可通过纤维蛋白溶解作用导致血栓消退。初始治疗时的血栓消退对于 VTE 患者至关重要。然而，DOAC 对癌症合并 VTE 患者的溶栓作用尚未得到充分研究。因此，在这项研究中，我们研究了利伐沙班对发生 VTE 的癌症患者的溶栓作用。
这是一项单臂、开放标签、前瞻性干预研究。纳入年龄在 20 至 75 岁之间、同意时已确诊为急性 VTE 且患有活动性癌症的 40 名患者。排除接受溶栓治疗、肌酐清除率<30ml/min、预期寿命<6 个月或仅限于小腿远端的深静脉血栓形成的患者。符合条件的患者接受利伐沙班标准治疗（15mg 每日两次，共 3 周，随后 15mg 每日一次）。主要研究终点是通过对比增强 CT 成像评估的血栓消退率。CT 成像在基线、利伐沙班治疗开始后 21±4 天和 90±14 天进行。次要终点是 VTE 复发和出血并发症。
这项研究得到了京都府立医科大学机构审查委员会的批准。研究结果将通过同行评议的期刊传播。UMIN000027793。
