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

Sponsor

Anthos Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05421533

Collaborator

CYTE Global (Other)

10,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Outcome Measures

Primary Outcome Measures

Distribution of characteristics of patients with AF, including reasons anticoagulation is not used [24 Months]
Information collected from physicians will provide the clinical reasons for treatment or nontreatment with OACs as assessed by the treating physicians
Bleeding [24 Months]
Number of all bleeding events in patients with AF who are treated with guideline recommended doses of oral anticoagulants for stroke prevention versus those who are not
Stroke and systemic embolic events [24 Months]
Number of stroke and systemic embolic events in patients with AF who are treated with guideline recommended doses of oral anticoagulants for stroke prevention versus those who are not

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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