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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Anhui Provincial Hospital; Huadong Hospital; Shanghai 5th People's Hospital; Shanghai Zhongshan Hospital; Sir Run Run Shaw Hospital; Yantai Yuhuangding Hospital; Zhejiang Provincial People's Hospital; Zhejiang Xiaoshan hospital
• Treatments: Nadroparin; Rivaroxaban; Warfarin

Criteria

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