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NCT06431789 Clinical Trial

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

Renal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06431789
Other study ID # SLCO1B1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date April 30, 2026

Study information
Verified date May 2024
Source Qianfoshan Hospital
Contact Yi Han, doctorate
Phone 15552565120
Email 15552565120@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. To provide reference for clinical rational use of edoxaban; 2. Optimize the individualized dosing regimen of edoxaban.

Description:

In this study, patients with moderate and severe renal insufficiency receiving edoxaban were selected as research objects. The potential safety of edoxaban in patients with different genotypes was evaluated by detecting the anti-XA factor activity and SLCO1B1 genotyping, so as to optimize the individualized administration regimen of edoxaban.

Recruitment information / eligibility
Status Recruiting
Enrollment 220
Est. completion date April 30, 2026
Est. primary completion date October 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ) Jinan Shandong

Sponsors (2)
Lead Sponsor Collaborator
Yi Han Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other Safety index:Thrombotic and bleeding events. Thrombotic and bleeding events. six months
Primary Anti-factor Xa activity Anti-factor Xa activity six months
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