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

NCT05421533 | Terminated

• 1 other identifier: ANT-401
• Study Type: observational
• Target: 705
• Locations: 12 countries
• Sites: 96

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.

Conditions

Atrial Fibrillation

Keywords

Observational Study; Real-World Evidence; Atrial Fibrillation; Stroke; Bleeding; Systemic Thromboembolic Event

Outcome Measures

Primary Outcomes (3)

• Distribution of characteristics of patients with AF, including reasons anticoagulation is not used

  Information collected from physicians will provide the clinical reasons for treatment or nontreatment with OACs as assessed by the treating physicians

  24 Months

• Bleeding

  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

  24 Months

• Stroke and systemic embolic events

  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

  24 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AF at elevated risk of stroke with advanced age, renal dysfunction, the need for concomitant antiplatelet use, or otherwise judged to be at increased risk of bleeding. Initial feasibility cohort will recruit approximately 1500 patients with AF who are not currently treated with oral anticoagulants at baseline before opening the study to patients with AF regardless of antithrombotic strategy.

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

Sponsors & Collaborators

• Anthos Therapeutics, Inc.: lead
• CYTE Global: collaborator

Study Sites (96)

Anthos Investigate Site

Fullerton, California, 92831, United States

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Boca Raton, Florida, 33486, United States

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Homestead, Florida, 33032, United States

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Atlanta, Georgia, 30342, United States

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Marietta, Georgia, 30062, United States

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Lanham, Maryland, 20706, United States

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Detroit, Michigan, 48202, United States

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Cary, North Carolina, 27518, United States

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Tomball, Texas, 77375, United States

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Caba, Buenos Aires, 4102, Argentina

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Coronel Suárez, Buenos Aires, 7540, Argentina

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La Plata, Buenos Aires, 1900, Argentina

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Quilmes, Buenos Aires, 1878, Argentina

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Ramos Mejía, Buenos Aires, B1704ETD, Argentina

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San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina

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Buenos Aires, Buenos Aires F.D., 1061, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Esperanza, Santa Fe Province, 3080, Argentina

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Granadero Baigorria, Santa Fe Province, 2152, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Corrientes, 3400, Argentina

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Córdoba, 5000, Argentina

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Salta, A4406BPF, Argentina

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San Luis, 5700, Argentina

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Santa Fe, 3000, Argentina

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Colatina, Espírito Santo, 29707-035, Brazil

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Campo Grande, Mato Grosso do Sul, 79080-190, Brazil

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Belo Horizonte, Minas Gerais, 30220-140, Brazil

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Campina Grande do Sul, Paraná, 83430000, Brazil

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Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

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Porto Alegre, Rio Grande do Sul, 9041000, Brazil

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Porto Alegre, Rio Grande do Sul, 90840440, Brazil

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Marília, São Paulo, 17515-000, Brazil

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São Paulo, São Paulo, 05403, Brazil

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São Paulo, São Paulo, 08270-070, Brazil

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Votuporanga, São Paulo, 15500-003, Brazil

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Abbotsford, British Columbia, V2S 0C2, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Oshawa, Ontario, L1J2K1, Canada

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Toronto, Ontario, M3N 3M5, Canada

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Québec, Quebec, G1R 2J6, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Jinočany, Central Bohemian, 25225, Czechia

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Náchod, Hradec Králové, 54701, Czechia

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Mariánské Lázně, Karlovy Vary, 35301, Czechia

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Trutnov, Královéhradecký kraj, 54101, Czechia

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Prague, Lekarna BENU, 15800, Czechia

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Prague, Praha 5 - Hlubocepy, 15200, Czechia

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Prague, Praha 5, 15006, Czechia

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Ústí nad Labem, Ústí Nad Labem Region, 40113, Czechia

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Obermichelbach, Bavaria, 90587, Germany

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Markkleeberg, Leipzig, 04416, Germany

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Ludwigshafen am Rhein, Ludwigshafen, 67063, Germany

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Dresden, Saxony, 1067, Germany

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Pirna, Sächsische Schweiz-Osterzgebirge, 01796, Germany

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Berlin, 12621, Germany

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Debrecen, Hajdú-Bihar Megye, 4032, Hungary

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Budapest, 1088, Hungary

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Napoli, Campania, 80131, Italy

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Bergamo, Lombardy, 24127, Italy

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Milan, Lombardy, 20128, Italy

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Roma, RM, 168, Italy

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Perugia, Umbria, 6156, Italy

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Bologna, 40138, Italy

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Sesto San Giovanni, 20099, Italy

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Varese, 21100, Italy

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Torreón, Coahuila, 27000, Mexico

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Mexico City, Cuauhtemoc, 6090, Mexico

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Guadalajara, Jalisco, 44670, Mexico

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San Pedro Garza García, Nuevo León, Mexico

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Culiacán, Sinaloa, 80230, Mexico

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Mexico City, 1120, Mexico

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Querétaro, 76000, Mexico

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Bochnia, Lesser Poland Voivodeship, 32-700, Poland

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Lublin, Lublin Voivodeship, 20-518, Poland

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Warsaw, Mazovian, 02-097, Poland

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Ostrów Mazowiecka, Ostrów Mazowiecka County, 07-300, Poland

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Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

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Bialystok, Podlaskie Voivodeship, 15-276, Poland

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Bialystok, Podlaskie Voivodeship, 15-875, Poland

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Czeladź, Silesian Voivodeship, 41-250, Poland

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Szczecin, Zach-pomorskie, 71-526, Poland

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Warsaw, 04141, Poland

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Lodz, Łódzkie Województwo, 94-046, Poland

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Skierniewice, Łódź Voivodeship, 96-100, Poland

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Sabadell, Barcelona, 8223, Spain

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Córdoba, Cabra, 14940, Spain

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Madrid, 28046, Spain

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Peterborough, Cambridgeshite, PE3 9GZ, United Kingdom

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Hayle, Cornwall, TR27 5DT, United Kingdom

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Norwich, Norfolk, NR2 2TJ, United Kingdom

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Ashington, Northumberland, NE63 9JJ, United Kingdom

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Newcastle, Tyne & Wear, NE7 7DN, United Kingdom

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Barry, Vale Of Glamorgan, CF63 1BA, United Kingdom

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Middlesex, TW7 6AF, United Kingdom

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MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 16, 2022
• Study Start: September 14, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (17); BR (11); US (9); ME (7); PL (12); IT (8); HU (2); ES (3); GB (7); DE (6); CZ (8); CA (6)