Status:
RECRUITING
Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Sir Run Run Shaw Hospital
Huadong Hospital
Conditions:
May-Thurner Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
Left Iliac Vein Compression Syndrome (LIVCS) is a disease of iliac vein stenosis/occlusion caused by chronic friction and compression of the left iliac vein by the right common iliac artery and lumbar...
Eligibility Criteria
Inclusion
- Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation
Exclusion
- 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
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT04067505
Start Date
May 18 2020
End Date
December 31 2024
Last Update
April 18 2024
Active Locations (9)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
2
Yantai Yuhuangding Hospital
Yantai, Shangdong, China, 264000
3
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200000
4
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, China, 200000