Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol
Bin Gao,
Li Yin,
Wei Han,
Libin Zhang,
Miaomiao Li,
Yuefeng Zhu,
Zhenyu Shi,
Wan Zhang,
Lubin Li,
Zhengdong Fang,
Guangwei Yang,
Linjun Wang,
Xueying Ke,
Jianing Yue,
Zheng Gu,
Zhenjie Liu
Affiliations
Bin Gao
Vascular Surgery, Shanghai Fifth People’s Hospital, Shanghai, China
Li Yin
Vascular Surgery, Zhejiang University School of Medicine Second Affiliated Hospital, Hangzhou, Zhejiang, China
Wei Han
1 Department of Epidemiology and Biostatistics, Institute of Basic Medical Science, Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College, Beijing, China
Libin Zhang
Vascular Surgery, Zhejiang University School of Medicine Second Affiliated Hospital, Hangzhou, Zhejiang, China
Miaomiao Li
Biotherapy Center and Cancer Center, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Yuefeng Zhu
Vascular Surgery, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China
Zhenyu Shi
2 Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin’s Clinical Research Center for Cancer, Tianjin, China
Wan Zhang
Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Lubin Li
Vascular Surgery, Qindao University Medical College Affiliated Yantai Yuhuangding Hospital, Yantai, Shandong, China
Zhengdong Fang
Vascular Surgery, Anhui Provincial Hospital, Hefei, Anhui, China
Guangwei Yang
Vascular Surgery, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang, China
Linjun Wang
Vascular Surgery, Third Peoplles Hospital of Hangzhou, Hangzhou, Zhejiang, China
Xueying Ke
Vascular Surgery, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China
Jianing Yue
Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, China
Zheng Gu
Department of Clinical Medicine Engineering, The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China
Zhenjie Liu
Vascular Surgery, Zhejiang University School of Medicine Second Affiliated Hospital, Hangzhou, Zhejiang, China
Introduction Inferior vena cava (IVC) filters are commonly used in patients with venous thromboembolism to prevent fatal pulmonary embolism, but the thrombosis risk increases after filter placement. Warfarin is a widely anticoagulant, but long-term monitoring and dose adjustments are required. Anticoagulation with rivaroxaban is more straightforward as it dose not require laboratory monitoring. This study compares the efficacy and safety of rivaroxaban and warfarin as an in anticoagulation therapy for patients with IVC filter placement.Methods and analysis This is a multicentre, randomised controlled trial. In total, 200 patients with deep vein thrombosis (DVT) with IVC filter implantation from 10 hospitals will be recruited. The patients will be randomised to the experimental group (rivaroxaban) or the control group (nadroparin overlapped with warfarin). The primary outcomes include death of any cause, pulmonary embolism (PE)-related death, bleeding and recurrent PE/DVT. The secondary outcomes include the percentage of other vascular events, IVC filter retrieval failure and net clinical benefits. This study aims to provide reliable, verification for the efficacy and safety of rivaroxaban antithrombotic therapy after IVC filter placement.Ethics and dissemination The study was approved by the Human Research Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine (approval number: (2019) 295). The results will be disseminated through presentations at scientific conferences and publications in peer-reviewed journalsTrial registration number NCT04066764.
