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
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
- 否
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
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
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
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
Zhenjie Liu
Principal Investigator
Second Affiliated Hospital, School of Medicine, Zhejiang University
