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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067505
Recruitment Status : Suspended (Adjustment of study protocol.)
First Posted : August 26, 2019
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
Sir Run Run Shaw Hospital
Huadong Hospital
Shanghai Zhongshan Hospital
Shanghai 5th People's Hospital
Yantai Yuhuangding Hospital
Anhui Provincial Hospital
Information provided by (Responsible Party):
Zhenjie Liu, Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
May-Thurner Syndrome Drug: Rivaroxaban Drug: Warfarin Drug: Nadroparin Phase 3

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, which results in blood flow disorders in lower limbs and pelvic veins. 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. Warfarin is a standard oral anticoagulant for a long time,with good anticoagulant effect and low price. 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. It's also not easy to interact with food or drugs. 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, and repeated coagulation monitoring is not required. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 18, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Rivaroxaban
Participants will receive rivaroxaban 15mg twice daily for three weeks, then 20mg oral once daily after operation.
Drug: Rivaroxaban
Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral
Other Name: Xarelto

Active Comparator: 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.
Drug: 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
Other Name: coumadin

Drug: Nadroparin
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
Other Name: Fraxiparin




Primary Outcome Measures :
  1. Anticoagulation-related mortality [ Time Frame: 2 year after operation ]
    Mortality directly caused by anticoagulation therapy

  2. Stent patency rate and incidence of thrombosis [ Time Frame: 2 year after operation ]
    Percentage of participants with thrombosis,such as deep vein thrombosis and pulmonary embolism.

  3. Quality of Life Change Scale Survey Results [ Time Frame: 2 year after operation ]
    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).


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 1, 3, 6, 12, 18 and 24 months after operation ]
    Percentage of participants with all deaths

  2. Percentage of participants with stent displacement/fracture [ Time Frame: 1, 3, 6, 12, 18 and 24 months after operation ]
    Events will be assessed based on computed tomography (CT) or X ray

  3. Percentage of participants with hemorrhage [ Time Frame: 1, 3, 6, 12, 18 and 24 months after operation ]
    Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding

  4. Percentage of participants with other vascular events [ Time Frame: 1, 3, 6, 12, 18 and 24 months after operation ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067505


Locations
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China, Anhui
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
China, Shangdong
Yantai Yuhuangding Hospital
Yantai, Shangdong, China, 264000
China, Shanghai
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai, China, 200000
Shanghai 5th People's Hospital
Shanghai, Shanghai, China, 200000
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai, China, 200000
China, Zhejiang
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Huadong Hospital
Shanghai Zhongshan Hospital
Shanghai 5th People's Hospital
Yantai Yuhuangding Hospital
Anhui Provincial Hospital
Investigators
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Principal Investigator: Zhejie Liu, MD,PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
Publications:
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Responsible Party: Zhenjie Liu, Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04067505    
Other Study ID Numbers: SAHZhejiangU-001
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhenjie Liu, Second Affiliated Hospital, School of Medicine, Zhejiang University:
May-Thurner Syndrome
warfarin
rivaroxaban
stent implantation
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
May-Thurner Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Peripheral Vascular Diseases
Congenital Abnormalities
Nadroparin
Warfarin
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents