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

May-Thurner Syndrome Clinical Trial

— PLICTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04067505
• Other study ID #: SAHZhejiangU-001
• Status: Recruiting
• Phase: Phase 3
• Start date: May 18, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Li Yin
• Phone: 86-0571-87913706
• Email: lawson4001[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 vertebra. It is also called Cockett syndrome or May-Thurner syndrome. Recently, left iliac vein balloon dilatation with stent implantation have been used to treat patients with LIVCS, and have achieved good results. However, no matter the iliac vein stenosis or occlusion, interventional therapy can directly cause local trauma and intimal injury, which is a clear inducement of local thrombosis. Therefore, high intensity anticoagulation therapy is still needed to prevent secondary thrombosis in stent after left iliac vein balloon dilatation with stent implantation. At present, the postoperative anticoagulation regimen of these patients is early heparin anticoagulant therapy, and later warfarin anticoagulant therapy. However, due to the narrow therapeutic window of the drug, patients need to adjust the dosage according to coagulation function under the guidance of doctors. Rivaroxaban can simplify treatment, and is safe. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism. However, Rivaroxaban lacks sufficient clinical data for adjuvant anticoagulation therapy after balloon dilatation with stent implantation. Therefore, this study should be carried out to provide the basis for LIVCS treatment guidelines and explore the clinical indications of rivaroxaban.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• May-Thurner Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
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	Anhui Provincial Hospital	Hefei	Anhui
China	Huadong Hospital affiliated to Fudan University	Shanghai	Shanghai
China	Shanghai 5th People's Hospital	Shanghai	Shanghai
China	Zhongshan Hospital affiliated to Fudan University	Shanghai	Shanghai
China	Yantai Yuhuangding Hospital	Yantai	Shangdong

Sponsors (9)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Anhui Provincial Hospital, Huadong Hospital, Shanghai 5th People's Hospital, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, Yantai Yuhuangding Hospital, Zhejiang Hospital, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Erratum In: J Bone Joint Surg Br. 2009 Aug;91(8):1120. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2022 Dec 10;400(10368):2048. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life Change Scale Survey Results	Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).	1, 3, 6, 12, 18 and 24 months after operation
Secondary	All cause mortality	Percentage of participants with all deaths	1, 3, 6, 12, 18 and 24 months after operation
Secondary	anticoagulation raleted mortality	Percentage of participants with anticoagulation raleted deaths	1, 3, 6, 12, 18 and 24 months after operation
Secondary	Proportion of participants with stent displacement/fracture	Events will be assessed based on computed tomography (CT) or X ray	1, 3, 6, 12, 18 and 24 months after operation
Secondary	Proportion of participants with hemorrhage	Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding	1, 3, 6, 12, 18 and 24 months after operation
Secondary	Proportion of participants with other vascular events	All vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, transient ischemic attack, pulmonary embolism, non-central nervous system systemic embolism or vascular death) will be assessed based results/films/images of confirmatory testing, and/or case summaries.	1, 3, 6, 12, 18 and 24 months after operation
Secondary	Proportion of participants with thrombosis		1, 3, 6, 12, 18 and 24 months after operation