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

Stopped early

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05421533

Run by

Anthos Therapeutics, Inc.

People needed

705

Starts

2022-09-14

Expected to finish

2024-09-30

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Anthos Investigate Site — Boca Raton, Florida, United States
• Anthos Investigative Site — Homestead, Florida, United States
• Anthos Investigate Site — Atlanta, Georgia, United States
• Anthos Investigate Site — Marietta, Georgia, United States
• Anthos Investigative Site — Lanham, Maryland, United States
• Anthos Investigate Site — Detroit, Michigan, United States
• Anthos Investigate Site — Cary, North Carolina, United States
• Anthos Investigate Site — Tomball, Texas, United States
• Anthos Investigate Site — Caba, Buenos Aires, Argentina
• Anthos Investigate Site — Coronel Suárez, Buenos Aires, Argentina
• Anthos Investigate Site — La Plata, Buenos Aires, Argentina
• Anthos Investigate Site — Quilmes, Buenos Aires, Argentina
• Anthos Investigate Site — Ramos Mejía, Buenos Aires, Argentina
• Anthos Investigate Site — San Nicolás de los Arroyos, Buenos Aires, Argentina
• Anthos Investigate Site — Buenos Aires, Buenos Aires F.D., Argentina
• Anthos Investigate Site — Córdoba, Córdoba Province, Argentina
• Anthos Investigate Site — Esperanza, Santa Fe Province, Argentina
• Anthos Investigate Site — Granadero Baigorria, Santa Fe Province, Argentina
• Anthos Investigate Site — Rosario, Santa Fe Province, Argentina
• Anthos Investigate Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Anthos Investigate Site — Corrientes, Argentina
• Anthos Investigate Site — Córdoba, Argentina
• Anthos Investigate Site — Salta, Argentina
• Anthos Investigate Site — San Luis, Argentina
• Anthos Investigate Site — Fullerton, California, United States

Full record on ClinicalTrials.gov

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