Edoxaban, Gene Polymorphism, Renal Insufficiency
Conditions
Keywords
Anti-factor Xa activity, Edoxaban, Moderate to severe renal insufficiency, Solute carrier organic anion transporter family member 1B1
Brief summary
1. To provide reference for clinical rational use of edoxaban; 2. Optimize the individualized dosing regimen of edoxaban.
Detailed 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.
Interventions
None listed
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-factor Xa activity | six months | Anti-factor Xa activity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety index:Thrombotic and bleeding events. | six months | Thrombotic and bleeding events. |
Countries
China