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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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

Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study (NCT04067505) is a Phase 3 interventional studying May-Thurner Syndrome, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For May-Thurner Syndrome, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 224 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused May-Thurner Syndrome subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Rivaroxaban

Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral

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

DRUG

Nadroparin

Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Anhui Provincial Hospital
Hefei, Anhui, China
Yantai Yuhuangding Hospital
Yantai, Shangdong, China
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04067505), the sponsor (Second Affiliated Hospital, School of Medicine, Zhejiang University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04067505 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04067505?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04067505?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04067505. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04067505. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.