NCT06431789RecruitingNot Applicable
Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency
Yi Han1 site in 1 country220 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Anti-factor Xa activity
Study Overview
Brief Summary
- To provide reference for clinical rational use of edoxaban;
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Anti-factor Xa activity
Time Frame: six months
Anti-factor Xa activity
Secondary Outcomes
No secondary outcomes reported
Investigators
Yi Han
Associate professor of pharmacy
Qianfoshan Hospital
Study Sites (1)
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