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
Who is this study for? Patients with left iliac vein compression treated with stent implantation
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation
Locations
Other Locations
China
Sir Run Run Shaw Hospital
RECRUITING
Hangzhou
The second affiliated hospital of zhejiang university school of medicine
RECRUITING
Hangzhou
Zhejiang Provincial people's hospital
RECRUITING
Hangzhou
Zhejiang Xiaoshan Hospital
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
Huadong Hospital affiliated to Fudan University
RECRUITING
Shanghai
Shanghai 5th People's Hospital
RECRUITING
Shanghai
Zhongshan Hospital affiliated to Fudan University
RECRUITING
Shanghai
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Contact Information
Primary
Li Yin
lawson4001@zju.edu.cn
86-0571-87913706
Time Frame
Start Date: 2020-05-18
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 224
Treatments
Experimental: Rivaroxaban
Participants will receive rivaroxaban 15mg twice daily for three weeks, then 20mg oral once daily after operation.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Anhui Provincial Hospital, Shanghai 5th People's Hospital, Huadong Hospital, Yantai Yuhuangding Hospital, Zhejiang Hospital, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital