study in atrial fibrillation (af) patients at high risk of stroke

Conditions: Atrial Fibrillation

Summary: 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.

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 criteria:
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

Keywords: observational study real-world evidence atrial fibrillation stroke bleeding systemic thromboembolic event