NCT05421533

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

A Global Prospective observationAl Study of Real-worlD managemEnt of patieNts With atrIal fibrillAtion at High Risk of Stroke (GARDENIA)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 705 (actual)
• Sponsor: Anthos Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2022-09-14
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2022-06-16
• Last updated: 2024-12-03

Locations

96 sites across 12 countries: United States, Argentina, Brazil, Canada, Czechia, Germany, Hungary, Italy, Mexico, Poland, Spain, United Kingdom