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

Last updated: April 16, 2024
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

3

Condition

Venous Thrombosis

Claudication

Venous Thromboembolism

Treatment

Warfarin

Nadroparin

Rivaroxaban

Clinical Study ID

NCT04067505
SAHZhejiangU-001
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 theanticoagulation intensity is clearly higher than that of the patients with iliac veintherapy 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

Study Design

Total Participants: 224
Treatment Group(s): 3
Primary Treatment: Warfarin
Phase: 3
Study Start date:
May 18, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shangdong 264000
    China

    Active - Recruiting

  • Huadong Hospital affiliated to Fudan University

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Shanghai 5th People's Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • The second affiliated hospital of zhejiang university school of medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Zhejiang Provincial people's hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Zhejiang Xiaoshan Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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