Switching anticoagulant management from a VKA to a NOAC-based tratment strategy in frail elderly patients with atrial fibrillatio

Recruiting

Conditions: atrial fibrillation
heart rhythm disorder
10007521

Registration Number: NL-OMON55760

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 2750

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: the first occurrence of the composite of at least one major or<br /><br>one clinically relevant non-major bleeding complication during the one-year<br /><br>follow-up period, following definitions from the International Society of<br /><br>Thrombosis and Haemostasis (ISTH).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include the endpoints of major or clinically relevant<br /><br>non-major bleeding complications separately, minor bleedings (i.g. all other<br /><br>bleeding events nor classified as major of CRNM), thrombo-embolic events, the<br /><br>occurrence of the composite of ischaemic and haemorrhagic stroke, quality of<br /><br>life, cost-effectiveness, and risk factors for bleeding.</p><br>