Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke
Launched by ANTHOS THERAPEUTICS, INC. · Jun 13, 2022
Trial Information
Current as of May 28, 2025
Terminated
Keywords
ClinConnect Summary
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 d...
Gender
ALL
Eligibility criteria
- 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
About Anthos Therapeutics, Inc.
Anthos Therapeutics, Inc. is a biotechnology company dedicated to advancing innovative therapies for patients with cardiovascular and metabolic diseases. Leveraging cutting-edge science and a robust pipeline of novel drug candidates, Anthos focuses on addressing unmet medical needs through precision medicine and targeted treatments. The company is committed to rigorous clinical research and collaboration with healthcare professionals to ensure the development of safe and effective therapies that enhance patient outcomes and improve quality of life. With a strong emphasis on scientific integrity and patient-centered care, Anthos Therapeutics aims to make a meaningful impact in the field of therapeutic innovation.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boca Raton, Florida, United States
Jamaica, New York, United States
Homestead, Florida, United States
Córdoba, Cabra, Spain
Mariánské Lázně, Karlovy Vary, Czechia
Trutnov, Královéhradecký Kraj, Czechia
Prague, Lekarna Benu, Czechia
ústí Nad Labem, ústí Nad Labem Region, Czechia
Obermichelbach, Bayern, Germany
Markkleeberg, Leipzig, Germany
Zwenkau, Leipzig, Germany
Pirna, Sächsische Schweiz Osterzgebirge, Germany
Warsaw, Kosciusko County, Poland
Ostrów Mazowiecka, Ostrów Mazowiecka County, Poland
Barry, Vale Of Glamorgan, United Kingdom
Lanham, Maryland, United States
Lublin, Lubelskie, Poland
Bochnia, Małopolskie, Poland
Skierniewice, łódź, Poland
Czeladź, śląskie, Poland
Cary, North Carolina, United States
Oshawa, Ontario, Canada
Náchod, Hradec Králové, Czechia
Praha, Praha 5 Hlubocepy, Czechia
Markkleeberg, Leipzig, Germany
Zwenkau, Leipzig, Germany
Pirna, Sächsische Schweiz Osterzgebirge, Germany
Rzeszów, Podkarpackie, Poland
Białystok, Podlaskie, Poland
Granada, , Spain
Hitchin, Hertfordshire, United Kingdom
Norwich, Norfolk, United Kingdom
Detroit, Michigan, United States
Brampton, Ontario, Canada
Praha, Praha 5, Czechia
Gräfenhainichen, Sachsen Anhalt, Germany
Dresden, Sachsen, Germany
Berlin, , Germany
Debrecen, Hajdú Bihar Megye, Hungary
Budapest, , Hungary
Madrid, , Spain
Basingstoke, Hampshire, United Kingdom
Tyler, Texas, United States
Ludwigshafen Am Rhein, Ludwigshafen, Germany
Ludwigshafen, , Germany
Mosonmagyaróvár, Gyor Moson Sopron, Hungary
Białystok, Podlaskie, Poland
Sabadell, Barcelona, Spain
Leicester, Leicestershite, United Kingdom
Ashington, Northumberland, United Kingdom
Jinočany, Central Bohemian, Czechia
Bergamo, Lombardy, Italy
Warszawa, , Poland
Coronel Suárez, Buenos Aires, Argentina
San Nicolas De Los Arroyos, Buenos Aires, Argentina
Peterborough, Ontario, Canada
Varese, , Italy
łódź, łódzkie Województwo, Poland
Buenos Aires, Caba, Argentina
Tucumán, Tucuman, Argentina
Salta, , Argentina
Newmarket, Ontario, Canada
Oakville, Ontario, Canada
Québec, Quebec, Canada
Seregélyes, Szekesfehervar, Hungary
Roma, Rm, Italy
Perugia, Umbria, Italy
Hayle, Cornwall, United Kingdom
Rosario, Santa Fe, Argentina
Sherbrooke, Quebec, Canada
Napoli, Campania, Italy
Sesto San Giovanni, , Italy
Peterborough, Cambridgeshite, United Kingdom
Middlesex, , United Kingdom
La Plata, Buenos Aires, Argentina
Esperanza, Santa Fe, Argentina
Granadero Baigorria, Santa Fe, Argentina
Corrientes, , Argentina
San Luis, , Argentina
São Paulo, Sao Paulo, Brazil
Toronto, Ontario, Canada
Milano, Lombardia, Italy
Rozzano, Mi, Italy
Bologna, , Italy
Corby, Northamptonshire, United Kingdom
Taunton, Somerset, United Kingdom
Quilmes, Buenos Aires, Argentina
Santa Fe, , Argentina
Campina Grande Do Sul, Parana, Brazil
Torreon, Coahuila, Mexico
Ciudad De Mexico, Cuauhtemoc, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
San Pedro Garza Garcia, Nuevo Leon, Mexico
Culiacán, Sinaloa, Mexico
Mexico City, , Mexico
Newcastle, Tyne & Wear, United Kingdom
Caba, Buenos Aires, Argentina
Ramos Mejía, Buenos Aires, Argentina
Colatina, Espírito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rs, Brazil
Halifax, Nova Scotia, Canada
Cambridge, Ontario, Canada
Warsaw, Mazovian, Poland
Szczecin, Zach Pomorskie, Poland
Atlanta, Georgia, United States
Marietta, Georgia, United States
Campo Grande, Mato Grosso Do Sul, Brazil
Teresina, Piauí, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Votuporanga, Sao Paulo, Brazil
Abbotsford, British Columbia, Canada
Catanzaro, , Italy
Fullerton, California, United States
Miami, Florida, United States
Macon, Georgia, United States
Tomball, Texas, United States
Córdoba, Cordoba, Argentina
Cordoba, , Argentina
Salvador, Bahia, Brazil
Garcia, Blumenau/Sc, Brazil
Passo Fundo, Rio Grande Do Sul, Brazil
Ribeirao Preto, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Marília, São Paulo, Brazil
São José Do Rio Preto, São Paulo, Brazil
Veracruz, , Mexico
Exeter, Devon, United Kingdom
Recife, Pernambuco, Brazil
Monterrey, Nuevo Leon, Mexico
Aguascalientes, , Mexico
Querétaro, , Mexico
Boca Raton, Florida, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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