An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial
Who is this study for? Patients with deep venous thrombosis
Status: Recruiting
Location: See all (7) 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 new oral anticoagulants and vitamin K antagonists for the anticoagulation for the implantation of vena cava filters in patients with deep venous thrombosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients who was diagnosed with deep venous thrombosis of the lower extremity and implanted with a retrievable inferior vena cava filter.
Locations
Other Locations
China
Sir Run Run Shaw Hospital
RECRUITING
Hangzhou
The second affiliated hospital of zhejiang university school of medicine
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 s Yin
lawson4001@zju.edu.cn
86-0571-87913706
Backup
Zhejie s Liu
lawson3001@gmail.com
15268135830
Time Frame
Start Date: 2020-05-08
Estimated Completion Date: 2024-10-01
Participants
Target number of participants: 200
Treatments
Experimental: Rivaroxaban
Participants will receive rivaroxaban 15mg oral twice daily for 3 weeks after operation, later rivaroxaban 20mg oral once daily until 3 months after the filter is retrieved.
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 3 months after the filter is retrieved.
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, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital