Status:
TERMINATED
Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke
Lead Sponsor:
Anthos Therapeutics, Inc.
Collaborating Sponsors:
CYTE Global
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
705 Patients enrolled
Trial Details
Trial ID
NCT05421533
Start Date
September 14 2022
End Date
September 30 2024
Last Update
December 3 2024
Active Locations (96)
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1
Anthos Investigate Site
Fullerton, California, United States, 92831
2
Anthos Investigate Site
Boca Raton, Florida, United States, 33486
3
Anthos Investigative Site
Homestead, Florida, United States, 33032
4
Anthos Investigate Site
Atlanta, Georgia, United States, 30342