医学
依杜沙班
改良兰金量表
临床终点
生物标志物
冲程(发动机)
随机对照试验
内科学
胃肠病学
缺血性中风
华法林
达比加群
心房颤动
缺血
生物化学
化学
机械工程
工程类
作者
Jong‐Won Chung,Jaechun Hwang,Hyung Jun Kim,Woo‐Keun Seo,Myung‐Ju Ahn,Jeffrey L. Saver,Oh Young Bang
标识
DOI:10.1177/17474930241239266
摘要
Background: This study aimed compare efficacy of edoxaban and enoxaparin upon biomarkers of hypercoagulability in patients with cancer-related embolic stroke of undetermined source (ESUS). Methods: In this open-label, randomized, pilot trial, patients with cancer-related ESUS within 30 days of diagnosis were randomly assigned (1:1) to receive edoxaban (60 mg once daily) or enoxaparin (1 mg/kg twice daily) for 90 days. The primary endpoint was interval change of serum D-dimer level between days 0 and 7. The secondary endpoints were microembolic signals detected by transcranial Doppler at 7 and 90 days, the modified Rankin scale score, and stroke recurrence during 90 days. Safety outcomes included major bleeding and all-cause death at 90 days. Results: Of 303 patients with ischemic stroke and cancer, 40 fully met enrollment criteria and were randomized. Baseline D-dimer levels were numerically higher in the edoxaban group (22.9 ± 15.9 μg/mL vs 16.9 ± 16.9 μg/mL). D-dimer level change (%) between days 0 and 7 was similar in the two groups (53.2 ± 25.7 vs 52.2 ± 52.0; P = 0.11). Microembolic signals were detected in 41.1% and 43.8% at baseline, 41.2% and 42.9% at day 7, and 25.0% and 28.6% at day 90 in the edoxaban and enoxaparin groups, respectively. Non-significantly higher major bleeding (35.0% vs 10.0%, P = 0.06) and 90-day mortality (40.0% vs 25.0%, P = 0.31) were noted in the edoxaban group. Conclusion: Edoxaban and enoxaparin were comparable with respect to the biomarkers of hypercoagulability and cerebral thromboembolism. Larger trials are warranted to compare effects of edoxaban and enoxaparin upon recurrent stroke and major bleeding in patients with cancer-related ESUS. Trial registration: clinicaltrials.gov Identifier: NCT03570281 ( https://clinicaltrials.gov/ct2/show/NCT03570281 )
科研通智能强力驱动
Strongly Powered by AbleSci AI