Using rivaroxaban to prevent blood clots in patients with May-Thurner syndrome after stent placement
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
This study is testing if the blood thinner rivaroxaban can help prevent blood clots in patients with May-Thurner syndrome after they have a stent placed.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 9 sites (Hefei, Anhui and 8 other locations) |
| Trial ID | NCT04067505 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of rivaroxaban, an anticoagulant, for preventing deep vein thrombosis in patients diagnosed with left iliac vein compression syndrome who have undergone stent implantation. The study aims to address the need for effective postoperative anticoagulation therapy, as traditional methods like warfarin require careful dosage adjustments. By simplifying treatment with rivaroxaban, the study seeks to improve patient outcomes and reduce the risk of thrombosis following interventional procedures. Participants will be monitored for safety and efficacy throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 75 with thrombotic left iliac vein compression syndrome who have received stent implantation.
Not a fit: Patients with contraindications for anticoagulation therapy, active bleeding risks, or those with certain comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anticoagulation option for patients undergoing stent implantation for May-Thurner syndrome.
How similar studies have performed: Previous studies have shown success with rivaroxaban in preventing deep vein thrombosis in other surgical contexts, but its use in this specific scenario is less established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hefei, Anhui and 8 other locations
- Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
- Yantai Yuhuangding Hospital — Yantai, Shangdong, China (Recruiting)
- Huadong Hospital affiliated to Fudan University — Shanghai, Shanghai, China (Recruiting)
- Shanghai 5th People's Hospital — Shanghai, Shanghai, China (Recruiting)
- Zhongshan Hospital affiliated to Fudan University — Shanghai, Shanghai, China (Recruiting)
- Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (Recruiting)
- The second affiliated hospital of zhejiang university school of medicine — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Provincial people's hospital — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Xiaoshan Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Zhejie Liu, MD,PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Li Yin
- Email: lawson4001@zju.edu.cn
- Phone: 86-0571-87913706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.