Department of Vascular Surgery, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, 310052, China.
School of Medicine, Zhejiang University, Hangzhou, 310009, Zhejiang Province, China.
Trials. 2020 Sep 29;21(1):811. doi: 10.1186/s13063-020-04742-z.
Balloon dilatation with stent implantation has been proved to be an effective option for left iliac vein compression syndrome (LIVCS), but thrombosis may still occur after the operation. Currently, warfarin is used for anticoagulant therapy, but long-term monitoring is required, while rivaroxaban does not need laboratory monitoring, which can simplify treatment. Therefore, this study aimed to compare the efficacy and safety of rivaroxaban and warfarin in anticoagulation.
This study is a multicenter, randomized controlled trial. We will recruit 224 patients with thrombotic LIVCS from 9 hospitals. Moreover, these patients will be randomized to either the experimental group (rivaroxaban) or the control group (warfarin plus nadroparin). The primary outcome is stent occlusion rate. Secondary outcomes are quality of life scale survey results, all-cause mortality, anticoagulation-related mortality, and the proportion of participants with stent displacement/fracture, thrombosis, hemorrhage, and other vascular events.
This study will provide reliable, evidence-based clinical evidence for the efficacy and safety of rivaroxaban antithrombotic therapy after stent implantation.
ClinicalTrials.gov NCT04067505 . Registered on August 26, 2019.
球囊扩张联合支架植入术已被证实为左髂静脉压迫综合征（LIVCS）的有效治疗选择，但术后仍可能发生血栓。目前，华法林被用于抗凝治疗，但需要长期监测，而利伐沙班无需实验室监测，可以简化治疗。因此，本研究旨在比较利伐沙班和华法林在抗凝治疗中的疗效和安全性。
本研究为多中心、随机对照试验。我们将从 9 家医院招募 224 例血栓性 LIVCS 患者。这些患者将被随机分配至实验组（利伐沙班）或对照组（华法林+那屈肝素钙）。主要结局为支架闭塞率。次要结局为生活质量量表调查结果、全因死亡率、抗凝相关死亡率以及支架移位/断裂、血栓形成、出血等血管事件发生率。
本研究将为支架植入术后利伐沙班抗栓治疗的疗效和安全性提供可靠的、基于证据的临床证据。
ClinicalTrials.gov NCT04067505，于 2019 年 8 月 26 日注册。
