2025-521362-10-00RecruitingPhase 4
Assessing the Efficacy of a Single Measurement and Adjustment Strategy for DOACs in Frail Older Patients.
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 9 Apr 2025
- Start date
- 6 Jan 2026
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Diseases
- Atrial fibrillation
- EU CT number
- 2025-521362-10-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2000
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for frail older adults who take a blood thinner (a DOAC) and can give informed consent. It tests a one-time blood level check and dose adjustment.
- Age
- Older than 70 years
- Sex
- All sexes can join
- Disease stage
- Frail, with a Clinical Frailty Scale (CFS) score above 3
- Earlier treatment
- Must be using a DOAC; people who are just starting a DOAC are preferred
Main reasons for not taking part
- Life expectancy under 3 months
- Not able to give informed consent
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Envida | Maastricht | Netherlands | Recruiting |
| MUMC+ | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.