Exploratory study to assess frailty as a clinical marker for the plasma concentrations of the direct oral anticoagulants (Frailty-DOAK)

Exploratory study to assess frailty as a clinical marker for the plasma concentrations of the direct oral anticoagulants (Frailty-DOAK) - Frailty-DOAK

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016741

Enrollment

240

Registered

2019-02-20

Start date

2019-02-27

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Frailty R54

Interventions

Group 1: Patients aged 70 years or older with regular intake of one of the direct oral anticoagulants (rivaroxaban, apixaban, edoxaban, dabigatran) will be assessed with four different frailty assessm

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Inclusion criteria

Inclusion criteria: •Age =70 years •Regular intake of one of the direct oral anticoagulants dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) or edoxaban (Lixiana®) during the past = 7 days •Mentally and physically able to participate in the study (as judged by a member of the study group) •Written informed consent

Exclusion criteria

Exclusion criteria: •Insufficient knowledge of written and/or spoken German •Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
•Correlation of four frailty assessments with the plasma trough concentrations of four direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban) -„Physical phenotype of frailty“ (Fried et al. 2001) -Frailty Index (Searle et al. 2008) -„FRAIL scale“ (Morley et al. 2012) -„Short Physical Performance Battery“ (SPPB) •Evaluation of the three groups „frail“, „pre-frail“ and „robust“ according to Fried et al. 2001 as to their ability to predict the plasma trough concentrations of the direct oral anticoagulants	—

Measure

Time frame

•Correlation of four frailty assessments with the plasma trough concentrations of four direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban) -„Physical phenotype of frailty“ (Fried et al. 2001) -Frailty Index (Searle et al. 2008) -„FRAIL scale“ (Morley et al. 2012) -„Short Physical Performance Battery“ (SPPB) •Evaluation of the three groups „frail“, „pre-frail“ and „robust“ according to Fried et al. 2001 as to their ability to predict the plasma trough concentrations of the direct oral anticoagulants

—

Secondary

Measure	Time frame
•Correlation of selected functional parameters (e.g. gait speed, grip strength) with the plasma trough concentrations of four direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban)	—

Countries

Germany

Contacts

Public ContactAnnette Eidam

Agaplesion Bethanien Krankenhaus Geriatrisches Zentrum der Universität Heidelberg

Annette.Eidam@bethanien-heidelberg.de06221-319-1795

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026