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Search / Trial NCT06431789

Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency

Launched by YI HAN · May 22, 2024

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Trial Information

Current as of March 14, 2025

Recruiting

Keywords

Anti Factor Xa Activity Edoxaban Moderate To Severe Renal Insufficiency Solute Carrier Organic Anion Transporter Family Member 1 B1

ClinConnect Summary

This clinical trial is studying how a specific gene, called SLCO1B1, affects how well a medication called edoxaban works in patients with moderate to severe kidney problems. Edoxaban is used to prevent blood clots in conditions like atrial fibrillation and deep vein thrombosis. The goal of the trial is to help doctors better understand how to use edoxaban safely and effectively for people with different genetic backgrounds and kidney function, so they can tailor the dosage to each patient’s needs.

To participate in this study, you need to be between 65 and 74 years old and have been prescribed edoxaban for at least five days. You should also have a certain level of kidney function, as measured by a test called creatinine clearance. However, if you are under 18, have specific heart conditions, or have taken certain medications recently, you may not be eligible. Participants will be monitored throughout the study, and your involvement could contribute to improving treatment options for patients with similar conditions in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula
  • • Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment
  • • Patients voluntarily participate and sign informed consent
  • Exclusion Criteria:
  • • Age \< 18 years old
  • • Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease
  • • The patient had used a combination of cyclosporine, erythromycin or ketoconazole or other P-glycoprotein inhibitors within 30 days prior to use or inclusion; Patients were using or had used amiodarone or dronedarone within 30 days prior to inclusion

Trial Officials

Yi Han, doctorate

Principal Investigator

Qianfoshan Hospital

About Yi Han

Yi Han is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodology and ethical standards, Yi Han collaborates with leading researchers and institutions to design and implement clinical trials across various therapeutic areas. The organization prioritizes patient safety and data integrity, leveraging cutting-edge technology and robust analytics to ensure the efficacy of its investigational products. By fostering a culture of collaboration and transparency, Yi Han strives to contribute significantly to the healthcare landscape and bring forth transformative treatments for patients in need.

Locations

Jinan, Shandong, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0