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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06431789
Enrollment
220
Registered
2024-05-29
Start date
2024-05-01
Completion date
2026-04-30
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edoxaban, Gene Polymorphism, Renal Insufficiency

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

Qianfoshan Hospital
CollaboratorOTHER
Yi Han
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

MeasureTime frameDescription
Anti-factor Xa activitysix monthsAnti-factor Xa activity

Other

MeasureTime frameDescription
Safety index:Thrombotic and bleeding events.six monthsThrombotic and bleeding events.

Countries

China

Contacts

Primary ContactYi Han, doctorate
15552565120@163.com15552565120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026