Comparing Rivaroxaban and Warfarin for Anticoagulation with Vena Cava Filters

An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial

This study is testing whether a new blood thinner called rivaroxaban works better and is safer than the traditional blood thinner warfarin for patients who need a vena cava filter because of deep vein clots.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 7 sites (Hefei, Anhui and 6 other locations)
• Trial ID: NCT04066764 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of new oral anticoagulants, specifically rivaroxaban, compared to traditional vitamin K antagonists like warfarin, for patients undergoing implantation of vena cava filters due to deep venous thrombosis (DVT). The research focuses on patients who have contraindications to standard anticoagulation therapy, assessing how these medications can prevent complications such as pulmonary embolism. The study aims to determine the best anticoagulation strategy to improve patient outcomes and reduce the risks associated with DVT and its treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with deep venous thrombosis of the lower extremities who have received a retrievable inferior vena cava filter.

Not a fit: Patients under 18 or over 75 years old, those with contraindications to anticoagulation therapy, or those with severe comorbidities 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 with DVT who require vena cava filters.

How similar studies have performed: Other studies have shown promising results with similar anticoagulation approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Patients who was diagnosed with deep venous thrombosis of the lower extremity and implanted with a retrievable inferior vena cava filter.

Exclusion Criteria:

* Age \< 18 years or age \> 75 years,
* With obvious contraindications for anticoagulation therapy,
* Allergic to iodine contrast agents in the past,
* Pregnant or breastfeeding women,
* With malignant tumors and life expectancy \< 1 year,
* Severe liver diseases (such as acute hepatitis, chronic active hepatitis or cirrhosis) or alanine aminotransferase levels were higher than three times the upper limit of normal.
* With other diseases that need anticoagulation,
* With previous heparin-induced thrombocytopenia,
* Bacterial endocarditis,
* Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg,
* Taking cytochrome P450 3A4(CYP-450 3A4) inhibitors or inducers
* With severe renal insufficiency (creatinine clearance \<30 mL/min)
* Allergic to the drug used in this study
* With permanent filter implantation

Where this trial is running

Hefei, Anhui and 6 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)

Study contacts

• Principal investigator: Zhejie Liu — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Li s Yin

Conditions Venous Thromboembolism; venous thromboembolism; rivaroxaban; vena cava filters