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

Zhejiang University

Status and phase: Enrolling; Phase 3

Conditions: May-Thurner Syndrome

Treatments: Drug: Nadroparin; Drug: Warfarin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT04067505

SAHZhejiangU-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

224 participants in 2 patient groups

Rivaroxaban

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban

Warfarin/Nadroparin

Active Comparator group

Description:

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.

Treatment:

Drug: Warfarin

Drug: Nadroparin