Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke (GARDENIA)

Anthos Therapeutics

Status: Terminated

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05421533

ANT-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 705 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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