Blood thinners for frail elderly with a heart rhythm disorder
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Atrial Fibrilation
- Registration Number
- EUCTR2017-000393-11-NL
- Lead Sponsor
- niversity Medical Center utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2750
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method