Assessing the Efficacy of a Single Measurement and Adjustment Strategy for DOACs in Frail Older Patients.
Key facts
- Where
- Maastricht, HollandiaSee the 2 sites
- Phase
- 4. fázis
Where in Hollandia
- EnvidaMaastricht, HollandiaTaking people
- MUMC+Maastricht, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Ziekenhuis Maastricht
- Trial code
- EU 2025-521362-10-00
- Record updated
- 2025. december 22.
- Original description
The primary aim of this study is to evaluate the efficacy of a Single Measurement and adjustment strategy based on DOAC levels in the frail older population on the incidence of complications, in particular thromboembolic events or bleedings as composite outcome.Read full original descriptionShow less
Assessing the Efficacy of a Single Measurement and Adjustment Strategy for DOACs in Frail Older Patients: Insights from the DOAC-FRAIL RCT. A step towards safe(r) DOAC utilization in the frail older population.
The primary aim of this study is to evaluate the efficacy of a Single Measurement and adjustment strategy based on DOAC levels in the frail older population on the incidence of complications, in particular thromboembolic events or bleedings as composite outcome.
Inclusion: In order to be eligible to participate in this study, a subject must meet all of the following criteria: (a) aged > 70 years; (b) using a DOAC (preferably among new users, defined as participants initiating treatment with a DOAC), (c) CFS > 3, (d) able to attend to the outpatient clinic (only applicable to community dwelling patients), and (e) able to provide informed consent.
Exclusion: A potential subject who meets any of the following criteria will be excluded from participation in this study: (1) a life expectancy < 3 months, (2) not able to provide informed consent.