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    Clinical Trial Results:
    Pharmacokinetics of edoxaban in geriatric patients with atrial fibrillation

    Summary
    EudraCT number
    		 2022-004136-26
    Trial protocol
    		 BE  
    Global end of trial date
    24 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2025
    First version publication date
    08 May 2025
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    S67063
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Leuven
    Sponsor organisation address
    UZ Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Clinical Trial Center, UZ Leuven, 00 3216 34 19 98, ctc@uzleuven.be
    Scientific contact
    Clinical Trial Center, UZ Leuven, 00 3216 34 19 98, ctc@uzleuven.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the pharmacokinetics (PK) of edoxaban in a special patient population of geriatric inpatients with atrial fibrillation
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval was obtained from the relevant Ethics Committee prior to study initiation. All participants or their legally authorized representatives provided written informed consent after receiving both verbal and written information about the study's purpose, procedures, risks, and benefits. Special attention was given to the vulnerability of the geriatric population, including assessment of their capacity to consent and close monitoring for adverse events. To minimize participant burden, a peripheral venous catheter was used for serial blood sampling, reducing the discomfort and risk associated with multiple venipunctures. Additionally, visits were scheduled to accommodate participants’ needs, and the number of blood samples was limited to what was essential for reliable pharmacokinetic analysis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    5
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 Start date of the recruitment: 1 September 2023 The last patient visit: 24 April 2024 All recruitment was conducted in the UZ Leuven, Belgium.

    Pre-assignment
    Screening details
    		 inclusion criteria: • Patients aged at least 75 years who are currently admitted to one of the geriatric wards • with atrial fibrillation and on edoxaban dose 30 or 60 mg • no anemia and clinically stable

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinding method is not applicable as it is a pharmacokinetics study

    Arms
    Arm title
    		 overall
    Arm description
    		 division into arms is not applicable as it is an observational pharmacokinetics study when all subjects received edoxaban and contributed to blood samples
    Arm type
    		 Experimental

    Investigational medicinal product name
    Edoxaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 and 60 mg

    Number of subjects in period 1
    		overall
    Started
    17
    Completed
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 5 5
        85 years and over
    		 12 12
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 87 (83 to 90) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    overall
    Reporting group description
    		 division into arms is not applicable as it is an observational pharmacokinetics study when all subjects received edoxaban and contributed to blood samples

    Subject analysis set title
    Subjects with PPI
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subset of the dataset which contains subjects co-medicated with proton pump inhibitor drugs

    Subject analysis set title
    Subjects without PPI
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subset of the dataset which contains subjects who were not co-medicated with proton pump inhibitor drugs

    Primary: Clearance

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    End point title
    		 Clearance
    End point description
    Edoxaban concentrations at these time points: pre-dose, 0.5, 1, 1.5, 2, 4, 5, 8 hours after dose, were used to build a population pharmacokinetics model that estimates edoxaban clearance in geriatric patients.
    End point type
    Primary
    End point timeframe
    0 until 24 hours after the dose
    End point values
    		 Subjects with PPI Subjects without PPI
    Number of subjects analysed
    10
    7
    Units: L/h
        median (confidence interval 95%)
    11.8 (11.7 to 12.1)
    9.01 (8.9 to 9.2)
    Statistical analysis title
    		 Population pharmacokinetics analysis
    Statistical analysis description
    Edoxaban concentrations at these time points: pre-dose, 0.5, 1, 1.5, 2, 4, 5, 8 hours after dose, were used to build a population pharmacokinetics model that estimates edoxaban clearance in geriatric patients.
    Comparison groups
    Subjects with PPI v Subjects without PPI
    Number of subjects included in analysis
    17
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 < 0.01
    Method
    		 non-linear mixed model
    Confidence interval
    Notes
    [1] - In this exploratory population pharmacokinetics analysis/modeling, no comparison groups were pre-specified. The categorization of groups with PPI and without PPI was based on the significance in the exploration of the important covariates.

    Primary: Volume of distribution

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    End point title
    		 Volume of distribution
    End point description
    End point type
    Primary
    End point timeframe
    0 until 24 hours after the dose
    End point values
    		 Subjects with PPI Subjects without PPI
    Number of subjects analysed
    10
    7
    Units: L
        median (confidence interval 95%)
    62.6 (53.02 to 72.6)
    47.6 (40.3 to 55.2)
    Statistical analysis title
    		 Population pharmacokinetics analysis
    Statistical analysis description
    Edoxaban concentrations at these time points: pre-dose, 0.5, 1, 1.5, 2, 4, 5, 8 hours after dose, were used to build a population pharmacokinetics model that estimates edoxaban volume of distribution in geriatric patients.
    Comparison groups
    Subjects without PPI v Subjects with PPI
    Number of subjects included in analysis
    17
    Analysis specification
    Post-hoc
    Analysis type
    		 other [2]
    P-value
    		 < 0.01
    Method
    		 non-linear mixed model
    Confidence interval
    Notes
    [2] - In this exploratory population pharmacokinetics analysis/modeling, no comparison groups were pre-specified. The categorization of groups with PPI and without PPI was based on the significance in the exploration of the important covariates.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    1 September 2023 - 24 April 2024
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This is an observational pharmacokinetics study which we only included those patients already received edoxaban routinely and collected their blood samples using catheter, so the adverse event related to this study was none.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    We expected to include 30 subjects; however, because of limited time and budget, we did not extend the study period. As a results, only 17 subjects were included and analyzed.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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