Blood thinners for frail elderly with a heart rhythm disorder

’Switching anticoagulant management from a VKA to a NOAC-based treatment strategy in frail elderly patients with atrial fibrillation (FRAIL-AF study) - FRAIL-AF study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000393-11-NL

Enrollment

2750

Registered

2017-07-03

Start date

2017-09-07

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Atrial Fibrilation

Interventions

Trade Name: Dabigatran ( Pradaxa) Pharmaceutical Form: Capsule, hard Trade Name: rivaroxaban (Xarelto) Pharmaceutical Form: Film-coated tablet Trade Name: apixaban (Eliquis) Pharmaceutical Form: Fil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age > 75 years; • Currently managed on VKA treatment for AF by one of the participating thrombosis services; • Groningen Frailty Indicator (GFI) = 3; • Willingness to switch from VKA management to a NOAC-based treatment strategy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2750

Exclusion criteria

Exclusion criteria: • Renal impairment, i.e. an eGFR below 30 ml/min/1.73m2. These patients will not be randomized for our main objective, but will be followed-up observationally in order to evaluate one of our secondary objectives (risk factors for bleeding); • Valvular AF: AF in the presence of a mechanical heart valve, and/or severe mitral valve stenosis; • Taking part in other medical scientific research; • Unwilling or unable to provide written informed consent by the patient.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Primary outcome: the first occurrence of the composite of at least one major or one clinically relevant non-major bleeding complication during the one-year follow-up period, following definitions from the International Society of Thrombosis and Haemostasis (ISTH). ;Timepoint(s) of evaluation of this end point: All patient will be contacted at 1, 3, 6, 9 and 12 month. ;Main Objective: The primary objective is to evaluate whether the impact of a strategy aimed at switching INR-guided VKA management to a NOAC-based treatment strategy reduces the occurrence of major or clinically relevant non-major bleeding complications in frail elderly patients with AF. Hereto we will assess the relative risk (hazard ratio) of the randomised groups with respect to the time to first occurrence of a major or clinically relevant non-major bleeding complication (whichever comes first);Secondary Objective: The two components of this composite outcome, major or clinically relevant non-major bleeding complications, will also be analysed as separate outcomes secondarily. Other secondary objectives include a comparison of both treatment strategies on the occurrence of all-cause thrombo-embolic events, the composite of ischaemic and haemorrhagic stroke, quality of life and cost-effectiveness, as well as an identification of risk factors for bleeding in frail elderly AF patients treated with either a VKA or a NOAC.	—

Measure

Time frame

Primary end point(s): Primary outcome: the first occurrence of the composite of at least one major or one clinically relevant non-major bleeding complication during the one-year follow-up period, following definitions from the International Society of Thrombosis and Haemostasis (ISTH). ;Timepoint(s) of evaluation of this end point: All patient will be contacted at 1, 3, 6, 9 and 12 month. ;Main Objective: The primary objective is to evaluate whether the impact of a strategy aimed at switching INR-guided VKA management to a NOAC-based treatment strategy reduces the occurrence of major or clinically relevant non-major bleeding complications in frail elderly patients with AF. Hereto we will assess the relative risk (hazard ratio) of the randomised groups with respect to the time to first occurrence of a major or clinically relevant non-major bleeding complication (whichever comes first);Secondary Objective: The two components of this composite outcome, major or clinically relevant non-major bleeding complications, will also be analysed as separate outcomes secondarily. Other secondary objectives include a comparison of both treatment strategies on the occurrence of all-cause thrombo-embolic events, the composite of ischaemic and haemorrhagic stroke, quality of life and cost-effectiveness, as well as an identification of risk factors for bleeding in frail elderly AF patients treated with either a VKA or a NOAC.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes include the endpoints of major or clinically relevant non-major bleeding complications separately, minor bleedings (i.g. all other bleeding events not classified as major of CRNM), thrombo-embolic events, the occurrence of the composite of ischaemic and haemorrhagic stroke, quality of life, cost-effectiveness, and risk factors for bleeding.;Timepoint(s) of evaluation of this end point: all secundairy outcomes will be evaluated at the end of the study	—

Measure

Time frame

Secondary end point(s): Secondary outcomes include the endpoints of major or clinically relevant non-major bleeding complications separately, minor bleedings (i.g. all other bleeding events not classified as major of CRNM), thrombo-embolic events, the occurrence of the composite of ischaemic and haemorrhagic stroke, quality of life, cost-effectiveness, and risk factors for bleeding.;Timepoint(s) of evaluation of this end point: all secundairy outcomes will be evaluated at the end of the study

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Countries

Netherlands

Contacts

Public ContactPrincipal Investigator

University Medical Center Utrecht

G.J.Geersing@umcutrecht.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 20, 2026