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临床试验/NCT04067505
NCT04067505招募中3 期

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):A Prospective Randomized Controlled Trial

Second Affiliated Hospital, School of Medicine, Zhejiang University9 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2020年5月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
224
试验地点
9
主要终点
stent occlusion rate

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation.

详细描述

Left Iliac Vein Compression Syndrome (LIVCS) is a disease of iliac vein stenosis/occlusion caused by chronic friction and compression of the left iliac vein by the right common iliac artery and lumbar vertebra. It is also called Cockett syndrome or May-Thurner syndrome. Recently, left iliac vein balloon dilatation with stent implantation have been used to treat patients with LIVCS, and have achieved good results. However, no matter the iliac vein stenosis or occlusion, interventional therapy can directly cause local trauma and intimal injury, which is a clear inducement of local thrombosis. Therefore, high intensity anticoagulation therapy is still needed to prevent secondary thrombosis in stent after left iliac vein balloon dilatation with stent implantation. At present, the postoperative anticoagulation regimen of these patients is early heparin anticoagulant therapy, and later warfarin anticoagulant therapy. However, due to the narrow therapeutic window of the drug, patients need to adjust the dosage according to coagulation function under the guidance of doctors. Rivaroxaban can simplify treatment, and is safe. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism. However, Rivaroxaban lacks sufficient clinical data for adjuvant anticoagulation therapy after balloon dilatation with stent implantation. Therefore, this study should be carried out to provide the basis for LIVCS treatment guidelines and explore the clinical indications of rivaroxaban.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation

排除标准

  • Age < 18 years or age > 75 years
  • With history of pelvic surgery, left iliac vein trauma and pelvic radiotherapy
  • With obvious contraindications for anticoagulation therapy
  • Allergic to iodine contrast agents in the past
  • With concomitant diseases that need high-intensity anticoagulation, and the anticoagulation intensity is clearly higher than that of the patients with iliac vein therapy alone
  • Active bleeding or potential bleeding risk
  • Pregnant or breastfeeding women
  • With pelvic tumors causing compression of left iliac vein,
  • With chronic venous insufficiency of lower extremities caused by K-T syndrome
  • With malignant tumors and life expectancy < 1 year
  • Taking cytochrome P450 3A4(CYP-450 3A4) inhibitors or inducers

研究组 & 干预措施

Rivaroxaban

Experimental

Participants will receive rivaroxaban 15mg twice daily for three weeks, then 20mg oral once daily after operation.

干预措施: Rivaroxaban (Drug)

Warfarin/Nadroparin

Active Comparator

Participants will receive nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 6 months.

干预措施: Warfarin (Drug)

Warfarin/Nadroparin

Active Comparator

Participants will receive nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 6 months.

干预措施: Nadroparin (Drug)

结局指标

主要结局

stent occlusion rate

时间窗: 2 year after operation

Stent occlusion is defined as DS \> 50% for each modality with no procedure performed on the treated segment

次要结局

  • Quality of Life Change Scale Survey Results(1, 3, 6, 12, 18 and 24 months after operation)
  • Proportion of participants with hemorrhage(1, 3, 6, 12, 18 and 24 months after operation)
  • All cause mortality(1, 3, 6, 12, 18 and 24 months after operation)
  • anticoagulation raleted mortality(1, 3, 6, 12, 18 and 24 months after operation)
  • Proportion of participants with stent displacement/fracture(1, 3, 6, 12, 18 and 24 months after operation)
  • Proportion of participants with other vascular events(1, 3, 6, 12, 18 and 24 months after operation)
  • Proportion of participants with thrombosis(1, 3, 6, 12, 18 and 24 months after operation)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhenjie Liu

Principal Investigator

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究点 (9)

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