Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study
NCT ID: NCT04067505
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
224 participants
INTERVENTIONAL
2020-05-18
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rivaroxaban
Participants will receive rivaroxaban 15mg twice daily for three weeks, then 20mg oral once daily after operation.
Rivaroxaban
Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral
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.
Warfarin
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
Nadroparin
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
Interventions
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Rivaroxaban
Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral
Warfarin
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
Nadroparin
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Huadong Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai 5th People's Hospital
OTHER
Yantai Yuhuangding Hospital
OTHER
Anhui Provincial Hospital
OTHER_GOV
Zhejiang Provincial People's Hospital
OTHER
Zhejiang Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Zhenjie Liu
Principal Investigator
Principal Investigators
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Zhejie Liu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Yantai Yuhuangding Hospital
Yantai, Shangdong, China
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial people's hospital
Hangzhou, Zhejiang, China
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu Z, Gao N, Shen L, Yang J, Zhu Y, Li Z, Si Y. Endovascular treatment for symptomatic iliac vein compression syndrome: a prospective consecutive series of 48 patients. Ann Vasc Surg. 2014 Apr;28(3):695-704. doi: 10.1016/j.avsg.2013.05.019. Epub 2013 Oct 27.
O'Sullivan GJ, Semba CP, Bittner CA, Kee ST, Razavi MK, Sze DY, Dake MD. Endovascular management of iliac vein compression (May-Thurner) syndrome. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):823-36. doi: 10.1016/s1051-0443(07)61796-5.
Hurst DR, Forauer AR, Bloom JR, Greenfield LJ, Wakefield TW, Williams DM. Diagnosis and endovascular treatment of iliocaval compression syndrome. J Vasc Surg. 2001 Jul;34(1):106-13. doi: 10.1067/mva.2001.114213.
Eriksson BI, Kakkar AK, Turpie AG, Gent M, Bandel TJ, Homering M, Misselwitz F, Lassen MR. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. J Bone Joint Surg Br. 2009 May;91(5):636-44. doi: 10.1302/0301-620X.91B5.21691.
Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.
Li M, Zhang L, Zhang K, Zhu Y, Shi Z, Zhang W, Gao B, Li L, Fang Z, Yin L, Chen B, Liu Z. 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): study protocol for a prospective randomized controlled trial. Trials. 2020 Sep 29;21(1):811. doi: 10.1186/s13063-020-04742-z.
Other Identifiers
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SAHZhejiangU-001
Identifier Type: -
Identifier Source: org_study_id
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