Robert D. McBane II, MD, Gonda Vascular Center, Mayo Clinic, 200 First Street SW, Rochester, MN, USA, Tel.: +1 507 266 3964, Fax: +1 507 266 1617, E-mail:
Thromb Haemost. 2017 Oct 5;117(10):1952-1961. doi: 10.1160/TH17-03-0193. Epub 2017 Aug 24.
Currently, low molecular weight heparin (LMWH) is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. The rationale and design of this investigator initiated Phase IV, multicenter, randomized, open label, superiority trial assessing the safety of apixaban versus dalteparin for cancer associated VTE is provided (ADAM-VTE; NCT02585713). The main aim of the ADAM-VTE trial is to test the hypothesis that apixaban is associated with a significantly lower rate of major bleeding compared to dalteparin in the treatment of cancer patients with acute VTE. The primary safety outcome is rate of major bleeding. Secondary efficacy objective is to assess the rates of recurrent VTE or arterial thromboembolism. Cancer patients with acute VTE (n=300) are randomized to receive apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) or dalteparin (200 IU/Kg daily for 30 days followed by 150 IU/kg daily thereafter) for 6 months. Stratification factors used for randomization include cancer stage and cancer specific risk of venous thromboembolism using the Khorana score. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium comprised of 90 oncology practices in the United States and Canada. Based on the hypothesis to be tested, we anticipate that these trial results will provide evidence supporting apixaban as an effective treatment of cancer associated VTE at lower rates of major bleeding compared to LMWH.
目前，低分子肝素（LMWH）是指南推荐的癌症相关静脉血栓栓塞症（VTE）患者的治疗方法。阿哌沙班虽已获批用于治疗急性 VTE，但在癌症患者中的应用数据有限。本研究发起的、多中心、随机、开放标签、优效性 IV 期临床试验旨在评估阿哌沙班治疗癌症相关 VTE 的安全性，其结果已发表（ADAM-VTE；NCT02585713）。ADAM-VTE 试验的主要目的是验证假设，即与达肝素相比，阿哌沙班治疗急性 VTE 的癌症患者主要出血率更低。主要安全性结局为主要出血率。次要疗效指标为评估复发性 VTE 或动脉血栓栓塞事件的发生率。急性 VTE 的癌症患者（n=300）随机分为阿哌沙班组（10mg 每日 2 次，连用 7 天，随后改为 5mg 每日 2 次）或达肝素组（200IU/Kg 每日，连用 30 天，随后改为 150IU/kg 每日），疗程均为 6 个月。随机分组的分层因素包括癌症分期和 Khorana 评分确定的静脉血栓栓塞症风险。试验中心来自学术和社区癌症研究联合会（ACCRU），该联盟由美国和加拿大的 90 个肿瘤学实践中心组成。基于待检验的假设，我们预计这些试验结果将提供证据，支持阿哌沙班作为癌症相关 VTE 的有效治疗方法，其主要出血率低于 LMWH。
