Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study

Phase 3RecruitingNCT04067505

Second Affiliated Hospital, School of Medicine, Zhejiang University224 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

May-Thurner Syndrome

Interventions

RivaroxabanDRUG

Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral

WarfarinDRUG

Dose: 3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until 6 months Duration: 6 months Frequency: once daily Application: oral

NadroparinDRUG

Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation Exclusion Criteria: * 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

Locations (9)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shangdong, China

RECRUITING

Outcomes

Primary Outcomes

stent occlusion rate

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

Time frame: 2 year after operation

Secondary Outcomes

Quality of Life Change Scale Survey Results

Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).