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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gene Polymorphism Edoxaban Renal Insufficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No