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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Rivaroxaban

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

DRUG

Warfarin

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

DRUG

Nadroparin

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

Locations (9)

Anhui Provincial Hospital
Hefei, Anhui, China
Yantai Yuhuangding Hospital
Yantai, Shangdong, China
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial people's hospital
Hangzhou, Zhejiang, China
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China