Clinical trial NCT04067505: Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: May-Thurner Syndrome
Keywords: May-Thurner Syndrome
warfarin
rivaroxaban
stent implantation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Huadong Hospital
name: Shanghai Zhongshan Hospital
name: Shanghai 5th People's Hospital
name: Yantai Yuhuangding Hospital
name: Anhui Provincial Hospital
name: Zhejiang Provincial People's Hospital
name: Zhejiang Hospital
First posted: 2019-08-26
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: stent occlusion rate
timeFrame: 2 year after operation
Secondary outcomes:
measure: Quality of Life Change Scale Survey Results
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
measure: All cause mortality
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
measure: anticoagulation raleted mortality
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
measure: Proportion of participants with stent displacement/fracture
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
measure: Proportion of participants with hemorrhage
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
measure: Proportion of participants with other vascular events
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
measure: Proportion of participants with thrombosis
timeFrame: 1, 3, 6, 12, 18 and 24 months after operation
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shangdong
city: Shanghai
country: China
facility: Huadong Hospital affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 5th People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of zhejiang university school of medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial people's hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Xiaoshan Hospital
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhejie Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
citation: 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.