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.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521362-10-00

Enrollment

2000

Registered

2025-07-28

Start date

2026-01-06

Completion date

Unknown

Last updated

2025-12-22

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

Conditions

Frail older patients with atrial fibrillation or venous thromboembolism

Brief summary

Our primary end point is the composite outcome of thromboembolic events or bleedings. Bleeding is defined as major bleeding or a clinically relevant non-major (CRNM) bleeding, based on the definition of the International Society on Thrombosis and Haemostasis (ISTH). Thromboembolic events include ischemic stroke, transient ischemic accident (TIA) en peripheral thromboembolism.

Detailed description

Our secondary end points are (1) the prevalence of deviant DOAC levels in the frail older population, (2) determinants are associated with a deviant DOAC level, (3) differences in quality of life between both groups, (4) the feasibility/acceptability of the Single Measurement and adjustment strategy via a qualitative study, (5) cost-effectiveness of the intervention, and (6) mortality.

Interventions

DRUGDABIGATRAN ETEXILATE

DRUGAPIXABAN

DRUGRIVAROXABAN

DRUGEDOXABAN

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Our primary end point is the composite outcome of thromboembolic events or bleedings. Bleeding is defined as major bleeding or a clinically relevant non-major (CRNM) bleeding, based on the definition of the International Society on Thrombosis and Haemostasis (ISTH). Thromboembolic events include ischemic stroke, transient ischemic accident (TIA) en peripheral thromboembolism.	—

Secondary

Measure	Time frame
Our secondary end points are (1) the prevalence of deviant DOAC levels in the frail older population, (2) determinants are associated with a deviant DOAC level, (3) differences in quality of life between both groups, (4) the feasibility/acceptability of the Single Measurement and adjustment strategy via a qualitative study, (5) cost-effectiveness of the intervention, and (6) mortality.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026