atrial fibrillation heart rhythm disorder
Conditions
Interventions
In the index group, the treating physician (general practitioners (GPs) or
cardiologists) will be encouraged to switch oral anticoagulant management from
INR-guided VKA-management to a NOAC-based ma
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age > 75 years 2. Currently managed on VKA treatment for AF by one of the participating thrombosis services 3. Groningen Frailty Indicator (GFI) 3 or higher 4. Willingness to switch from VKA management to a NOAC-based treatment strategy.
Exclusion criteria
Exclusion criteria: 1. Renal impairement, i.e. eGFR below 30 ml/min/1.73m2 (these patients will not be randomized for our main objective, but will be followed observationally in order to evaluate our secondairy objective: risk factors for bleeding) 2. Valvular AF: AF in the presence of a mechanical heart valve, and/ or severe mitral valve stenosis 3. Taking part in other medical scientific research. 4. Unwilling/ unable to provide written informed consent bij the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the endpoints of major or clinically relevant non-major bleeding complications separately, minor bleedings (i.g. all other bleeding events nor 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. | — |
Countries
Netherlands
Outcome results
None listed