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
Second Affiliated Hospital, School of Medicine, Zhejiang University
224 participants
May 18, 2020
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation
Exclusion Criteria11
- 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
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Interventions
Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral
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
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
Locations(9)
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NCT04067505