Edoxaban disposition in geriatric patients with irregular heart rhythm

Pharmacokinetics of edoxaban in geriatric patients with atrial fibrillation - PEARL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-004136-26-BE

Enrollment

Registered

2023-01-19

Start date

2023-06-28

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Stroke prevention in atrial fibrillation MedDRA version: 20.0 Level: LLT Classification code 10016566 Term: Fibrillation atrial System Organ Class: 100000004849

Interventions

Trade Name: Lixiana 60 mg Product Name: Edoxaban (Lixiana) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Edoxaban CAS Number: 480449-71-6 Other descriptive name: Edoxaban tosylate Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients aged 75 years or more who are currently admitted to one of the geriatric wards and remain so for the entire duration of the study • Patients with paroxysmal or permanent atrial fibrillation who are on first dose or maintenance edoxaban dose for stroke prevention • Patients have to be medically stable, according to both the clinical and research team, based on clinical judgment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Unable to understand or speak Dutch.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the pharmacokinetics (PK) of edoxaban in a special patient population of geriatric inpatients;Secondary Objective: To develop a PK model to characterize the relationship between edoxaban exposure and patient characteristics. To evaluate the correlation between anti-Xa activity level and edoxaban plasma concentration. To evaluate the agreement between volumetric absorptive microsampling with venepuncture sampling method. ;Primary end point(s): The primary endpoints are PK metrics including trough and peak concentrations, and area under the curve from time 0 to infinity (AUC0-inf) derived from edoxaban plasma concentrations quantified by using LC-MS/MS assay and anti-Xa chromogenic assay. ;Timepoint(s) of evaluation of this end point: pre-dose, 0.5, 1, 1.5, 2, 4, 5, 8, 12 hours after dose	—

Measure

Time frame

Main Objective: To explore the pharmacokinetics (PK) of edoxaban in a special patient population of geriatric inpatients;Secondary Objective: To develop a PK model to characterize the relationship between edoxaban exposure and patient characteristics. To evaluate the correlation between anti-Xa activity level and edoxaban plasma concentration. To evaluate the agreement between volumetric absorptive microsampling with venepuncture sampling method. ;Primary end point(s): The primary endpoints are PK metrics including trough and peak concentrations, and area under the curve from time 0 to infinity (AUC0-inf) derived from edoxaban plasma concentrations quantified by using LC-MS/MS assay and anti-Xa chromogenic assay. ;Timepoint(s) of evaluation of this end point: pre-dose, 0.5, 1, 1.5, 2, 4, 5, 8, 12 hours after dose

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are PK parameters of absorption, distribution and elimination estimated by using population PK modeling;Timepoint(s) of evaluation of this end point: pre-dose, 0.5, 1, 1.5, 2, 4, 5, 8, 12 hours after dose	—

Countries

Belgium

Contacts

Public ContactClinical Trial Center

UZ Leuven

ctc@uzleuven.be003216 34 19 98

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026