当前位置: 首页 > 详情页

Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): an open-label, randomized controlled trial

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

机构: [1]Department of Emergency, Xuanwu Hospital, Capital Medical University. [2]Department of Neurology, Xuanwu Hospital, Capital Medical University. [3]Department of Neurology, Beijing Fengtai You'anmen Hospital. [4]Department of Neurosurgery, Xuanwu Hospital Capital Medical University.
出处:
ISSN:

关键词: Cerebral venous thrombosis NOACs dabigatran etexilate warfarin RCT China

摘要:
The efficacy and safety of dabigatran etexilate for Chinese patients with cerebral venous thrombosis (CVT) has not been well established.CHOICE-CVT was an exploratory, single-center, randomized, open-label study in the National Center for Neurological Disorders involving Chinese patients with CVT aged 18 to 80 years who were randomly assigned (1:1) to either dabigatran etexilate or warfarin. Oral anticoagulants were initiated after 10-15 days of LMWH. The primary efficacy and safety endpoints included the number of patients with recurrent CVT and/or deep venous thrombosis (DVT) and major clinical bleeding within 180 days. Secondary efficacy endpoints included venous recanalization and change in papilledema at day 180. Secondary safety outcomes comprised death, clinical non-major bleeding, and any bleeding. The study was registered with ClinicalTrials.gov under NCT03930940.Between October 2017 and February 2023, a total of 89 patients were enrolled and randomly assigned to receive either dabigatran etexilate (n=44) or warfarin (n=45). At day 180, the dabigatran etexilate group showed a statistically non-significant but likely clinically significant number of patients with recurrent CVT and/or DVT (8 [18.2%; 95%CI, 6.3-30.0] vs 3 [6.7%; 95%CI, 0.0-14.2], P=0.099, with a power [1-β] of 38.401%) compared to the warfarin group. The dabigatran etexilate group showed a comparable number of patients with clinical major bleeding (0 [0] vs 0 [0], P=1.000), and clinical non-major bleeding (1 [2.3%; 95%CI, 0.0-6.9] vs 1 [2.2%; 95%CI, 0.0-6.7]) but demonstrated a lower risk of any bleeding (1 [2.3%; 95%CI, 0.0-6.9] vs 9 [20.0%; 95%CI, 7.8-32.2]) compared to the warfarin group. Most patients in both groups achieved venous recanalization according to the Modified Qureshi scale (27 [75%; 95%CI, 60.1-89.9] in the dabigatran etexilate group versus 34 [82.9%; 95%CI, 70.9-95.0] in the warfarin group) and exhibited improvement in papilledema as per the Frisén classification (35 [97.2%; 95%CI, 91.6-100.0] in dabigatran etexilate group vs. 37 [88.1%, 95%CI, 77.9-98.3] in warfarin group).These findings regarding efficacy and safety support the consideration of dabigatran etexilate therapy as a viable treatment option for Chinese patients with CVT.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2023]版:
大类 | 2 区 医学
小类 | 2 区 临床神经病学 2 区 外周血管病
最新[2023]版:
大类 | 2 区 医学
小类 | 2 区 临床神经病学 2 区 外周血管病
JCR分区:
出版当年[2022]版:
Q1 CLINICAL NEUROLOGY Q1 PERIPHERAL VASCULAR DISEASE
最新[2023]版:
Q1 CLINICAL NEUROLOGY Q1 PERIPHERAL VASCULAR DISEASE

影响因子: 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者:
第一作者机构: [1]Department of Emergency, Xuanwu Hospital, Capital Medical University. [2]Department of Neurology, Xuanwu Hospital, Capital Medical University.
共同第一作者:
通讯作者:
通讯机构: [1]Department of Emergency, Xuanwu Hospital, Capital Medical University. [2]Department of Neurology, Xuanwu Hospital, Capital Medical University.
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:16409 今日访问量:0 总访问量:869 更新日期:2025-01-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 首都医科大学宣武医院 技术支持:重庆聚合科技有限公司 地址:北京市西城区长椿街45号宣武医院