Journal
BMJ OPEN
Volume 11, Issue 10, Pages -Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2020-045530
Keywords
vascular medicine; vascular surgery; clinical trials; thromboembolism
Categories
Funding
- Department of Science and Technology of Zhejiang Province [LGF19H180019]
- Zhejiang University 2018 Zhejiang Provincial Department of Education General Research Project (Natural Science) [Y201840845]
- Medical and Health Science and Technology Plan Project of Zhejiang Province [2019PY033]
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This study is a multicentre, randomized controlled trial comparing the efficacy and safety of rivaroxaban and warfarin as anticoagulation therapy for patients with IVC filter placement. The primary outcomes include death of any cause, PE-related death, bleeding, and recurrent PE/DVT. The study aims to provide reliable evidence for the efficacy and safety of rivaroxaban therapy after IVC filter placement.
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 journals
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