Overview
The GARDENIA registry will collect real-world clinical data on the anticoagulant strategies in patients with AF at elevated risk of stroke but also elevated risk of bleeding.
Description
The GARDENIA registry will collect real-world clinical data on the utilization of oral anticoagulants in patients with atrial fibrillation (AF) at elevated risk of stroke. Patients with AF who meet 1 or more of the following criteria will be recruited: advanced age, renal dysfunction, the need for concomitant antiplatelet use, or otherwise judged to be at a higher risk of bleeding. Patients with these criteria are frequently not treated with currently approved oral anticoagulants or they are 'undertreated' based on the use of non-recommended doses of anticoagulants. These patients will be described with regards to baseline demographics and characteristics with particular attention focused on physician and patient factors that may play a role in the under use of guideline-recommended anticoagulation therapy for stroke prevention in patients with AF. Patients in the registry will also be followed to determine the rates of discontinuation/switching of their anticoagulation therapy, incidence of major adverse cardiovascular events and clinically relevant outcome events related to the selection of their anticoagulation therapy. The collected real-world data will be used to inform future studies of patients with AF at elevated risk of stroke.
Eligibility
Inclusion Criteria:
- Written informed consent from the patient, or legally authorized representative, must be obtained before any assessment is performed
- Patients with diagnosed AF or atrial flutter(documented on an electrocardiogram or monitor recording)
- CHA2DS2-VASc score ≥2 excluding female as a factor
- Judged by the investigator to be at increased risk of bleeding because of at least 1
of the following:
- Age ≥70on the day of informed consent
- Reduced renal function (creatinine clearance <30mL/min by Cockcroft-Gault)
- Chronic use of NSAIDs or antiplatelet agents
- Any other condition associated with increased risk such as a prior history of major or clinically relevant nonmajor bleeding, increased fall risk, or frailty
- Patients who are not treated with oral anticoagulants (only applies to the initial
feasibility cohort)
Exclusion Criteria:
- Mechanical heart valve or valve disease that is expected to require valve replacement intervention (surgical or invasive) during the course of the registry study
- AF due to a reversible cause (eg, cardiac surgery, pulmonary embolism, untreated hyperthyroidism, ethanol use)
- Clinical unstable or active endocarditis or endovascular infection
- Patients with a medical condition other than AF for which chronic use of an oral anticoagulant is indicated
- History of left atrial appendage closure or removal
- Life expectancy <1 year at the time of enrollment as assessed by the investigator
- Any medical or psychiatric condition which in the judgment of the Investigator may preclude patients from complying with study requirements for the duration of the study