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

NCT04067505 | Recruiting Phase 3

• 1 other identifier: SAHZhejiangU-001
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 9

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.

Conditions

May-Thurner Syndrome

Keywords

May-Thurner Syndrome; warfarin; rivaroxaban; stent implantation

Outcome Measures

Primary Outcomes (1)

• stent occlusion rate

  Stent occlusion is defined as DS \> 50% for each modality with no procedure performed on the treated segment

  2 year after operation

Secondary Outcomes (7)

• Quality of Life Change Scale Survey Results

  1, 3, 6, 12, 18 and 24 months after operation

• All cause mortality

  1, 3, 6, 12, 18 and 24 months after operation

• anticoagulation raleted mortality

  1, 3, 6, 12, 18 and 24 months after operation

• Proportion of participants with stent displacement/fracture

  1, 3, 6, 12, 18 and 24 months after operation

• Proportion of participants with hemorrhage

  1, 3, 6, 12, 18 and 24 months after operation

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Participants will receive rivaroxaban 15mg twice daily for three weeks, then 20mg oral once daily after operation.

Drug: Rivaroxaban

Warfarin/Nadroparin

ACTIVE COMPARATOR

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.

Drug: Warfarin; Drug: Nadroparin

Interventions

Rivaroxaban DRUG

Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral

Also known as: Xarelto

Rivaroxaban

Warfarin DRUG

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

Also known as: coumadin

Warfarin/Nadroparin

Nadroparin DRUG

Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous

Also known as: Fraxiparin

Warfarin/Nadroparin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• Huadong Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shanghai 5th People's Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Zhejiang Hospital: collaborator

Study Sites (9)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shangdong, 264000, China

RECRUITING

Huadong Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai 5th People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Zhejiang Provincial people's hospital

Hangzhou, Zhejiang, China

RECRUITING

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 24559785 BACKGROUND

• 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.

  PMID: 10928517 BACKGROUND

• 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.

  PMID: 11436082 BACKGROUND

• 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.

  PMID: 19407299 BACKGROUND

• 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.

  PMID: 19411100 BACKGROUND

• 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.

  PMID: 32993773 DERIVED

MeSH Terms

Conditions

May-Thurner Syndrome

Interventions

Rivaroxaban; Warfarin; Nadroparin

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Zhejie Liu, MD,PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yin

CONTACT

86-0571-87913706; lawson4001@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: August 26, 2019
• Study Start: May 18, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CN (9)