An efficacy and safety study of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation (PLICTS): study protocol for a prospective randomized controlled trial

Trials

Kaijie Zhang¹  Wan Zhang²  Yuefeng Zhu³  Bin Gao⁴  Zhengdong Fang⁵  Bing Chen⁶  Li Yin⁶  Libin Zhang⁶  Zhenjie Liu⁶  Miaomiao Li⁷  Lubin Li⁸  Zhenyu Shi⁹ 

[1] Department of Cardiology, Sir Run Run Shaw Hospital of Zhejiang University, School of Medicine, 310016, Hangzhou, China;Department of Vascular Surgery, Huadong Hospital of Fudan University, 210023, Shanghai, China;Department of Vascular Surgery, Sir Run Run Shaw Hospital of Zhejiang University, School of Medicine, 310016, Hangzhou, China;Department of Vascular Surgery, The Fifth People’s Hospital of Shanghai, Fudan University, 200240, Shanghai, China;Department of Vascular Surgery, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, 230001, Hefei, Anhui, People’s Republic of China;Department of Vascular Surgery, The Second Affiliated Hospital of Zhejiang University, School of Medicine, 310052, Hangzhou, China;Department of Vascular Surgery, The Second Affiliated Hospital of Zhejiang University, School of Medicine, 310052, Hangzhou, China;School of Medicine, Zhejiang University, 310009, Hangzhou, Zhejiang Province, China;Department of Vascular Surgery, Yantai Yuhuangding Hospital, 264000, Yantai, China;Department of Vascular Surgery, Zhongshan Hospital of Fudan University, 210023, Shanghai, China;

关键词: Left iliac vein compression syndrome;    Thrombotic;    Warfarin;    Rivaroxaban;    Stent implantation;   

DOI  :  10.1186/s13063-020-04742-z

来源: Springer

【 摘 要 】

BackgroundBalloon 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.MethodsThis 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.DiscussionThis study will provide reliable, evidence-based clinical evidence for the efficacy and safety of rivaroxaban antithrombotic therapy after stent implantation.Trial registrationClinicalTrials.gov NCT04067505. Registered on August 26, 2019.

【 授权许可】

CC BY