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

NCT ID: NCT05421533

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

705 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-14

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CYTE Global

NETWORK

Sponsor Role collaborator

Anthos Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anthos Investigate Site

Fullerton, California, United States

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Boca Raton, Florida, United States

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Homestead, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Lanham, Maryland, United States

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Detroit, Michigan, United States

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Cary, North Carolina, United States

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Tomball, Texas, United States

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Caba, Buenos Aires, Argentina

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Coronel Suárez, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Ramos Mejía, Buenos Aires, Argentina

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San Nicolás de los Arroyos, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Córdoba, Córdoba Province, Argentina

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Esperanza, Santa Fe Province, Argentina

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Granadero Baigorria, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Salta, , Argentina

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San Luis, , Argentina

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Santa Fe, , Argentina

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Colatina, Espírito Santo, Brazil

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Campo Grande, Mato Grosso do Sul, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Campina Grande do Sul, Paraná, Brazil

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Passo Fundo, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Marília, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Votuporanga, São Paulo, Brazil

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Abbotsford, British Columbia, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Jinočany, Central Bohemian, Czechia

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Náchod, Hradec Králové, Czechia

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Mariánské Lázně, Karlovy Vary, Czechia

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Trutnov, Královéhradecký kraj, Czechia

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Prague, Lekarna BENU, Czechia

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Prague, Praha 5 - Hlubocepy, Czechia

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Prague, Praha 5, Czechia

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Ústí nad Labem, Ústí Nad Labem Region, Czechia

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Obermichelbach, Bavaria, Germany

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Markkleeberg, Leipzig, Germany

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Ludwigshafen am Rhein, Ludwigshafen, Germany

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Dresden, Saxony, Germany

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Pirna, Sächsische Schweiz-Osterzgebirge, Germany

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Berlin, , Germany

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Debrecen, Hajdú-Bihar Megye, Hungary

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Budapest, , Hungary

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Napoli, Campania, Italy

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Bergamo, Lombardy, Italy

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Milan, Lombardy, Italy

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Roma, RM, Italy

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Perugia, Umbria, Italy

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Bologna, , Italy

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Sesto San Giovanni, , Italy

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Varese, , Italy

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Torreón, Coahuila, Mexico

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Mexico City, Cuauhtemoc, Mexico

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Guadalajara, Jalisco, Mexico

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San Pedro Garza García, Nuevo León, Mexico

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Culiacán, Sinaloa, Mexico

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Mexico City, , Mexico

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Querétaro, , Mexico

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Bochnia, Lesser Poland Voivodeship, Poland

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Lublin, Lublin Voivodeship, Poland

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Warsaw, Mazovian, Poland

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Ostrów Mazowiecka, Ostrów Mazowiecka County, Poland

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Rzeszów, Podkarpackie Voivodeship, Poland

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Bialystok, Podlaskie Voivodeship, Poland

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Bialystok, Podlaskie Voivodeship, Poland

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Czeladź, Silesian Voivodeship, Poland

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Szczecin, Zach-pomorskie, Poland

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Warsaw, , Poland

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Lodz, Łódzkie Województwo, Poland

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Skierniewice, Łódź Voivodeship, Poland

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Sabadell, Barcelona, Spain

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Córdoba, Cabra, Spain

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Madrid, , Spain

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Peterborough, Cambridgeshite, United Kingdom

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Hayle, Cornwall, United Kingdom

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Norwich, Norfolk, United Kingdom

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Ashington, Northumberland, United Kingdom

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Newcastle, Tyne & Wear, United Kingdom

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Barry, Vale Of Glamorgan, United Kingdom

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Middlesex, , United Kingdom

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Countries

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United States Argentina Brazil Canada Czechia Germany Hungary Italy Mexico Poland Spain United Kingdom

Other Identifiers

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ANT-401

Identifier Type: -

Identifier Source: org_study_id