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

A Global Prospective observationAl Study of Real-worlD managemEnt of patieNts With atrIal fibrillAtion at High Risk of Stroke (GARDENIA)

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation

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 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.

• Study Type: Observational
• Enrollment (Actual): 705

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5000
    • Anthos Investigate Site
  • Corrientes, Argentina, 3400
    • Anthos Investigate Site
  • Salta, Argentina, A4406BPF
    • Anthos Investigate Site
  • San Luis, Argentina, 5700
    • Anthos Investigate Site
  • Santa Fe, Argentina, 3000
    • Anthos Investigate Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 4102
      • Anthos Investigate Site
    • Coronel Suárez, Buenos Aires, Argentina, 7540
      • Anthos Investigate Site
    • La Plata, Buenos Aires, Argentina, 1900
      • Anthos Investigate Site
    • Quilmes, Buenos Aires, Argentina, 1878
      • Anthos Investigate Site
    • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
      • Anthos Investigate Site
    • San Nicolas de los Arroyos, Buenos Aires, Argentina, 2900
      • Anthos Investigate Site
  • Caba
    • Buenos Aires, Caba, Argentina, 1061
      • Anthos Investigate Site
  • Cordoba
    • Córdoba, Cordoba, Argentina, 5000
      • Anthos Investigate Site
  • Santa Fe
    • Esperanza, Santa Fe, Argentina, 3080
      • Anthos Investigate Site
    • Granadero Baigorria, Santa Fe, Argentina, 2152
      • Anthos Investigate Site
    • Rosario, Santa Fe, Argentina, 2000
      • Anthos Investigate Site
  • Tucuman
    • Tucumán, Tucuman, Argentina, 4000
      • Anthos Investigate Site
• Brazil
  • Espírito Santo
    • Colatina, Espírito Santo, Brazil, 29707-035
      • Anthos Investigate Site
  • Mato Grosso Do Sul
    • Campo Grande, Mato Grosso Do Sul, Brazil, 79080-190
      • Anthos Investigate Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30220-140
      • Anthos Investigate Site
  • Parana
    • Campina Grande Do Sul, Parana, Brazil, 83430000
      • Anthos Investigate Site
  • RS
    • Porto Alegre, RS, Brazil, 9041000
      • Anthos Investigate Site
    • Porto Alegre, RS, Brazil, 90840440
      • Anthos Investigate Site
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
      • Anthos Investigate Site
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403
      • Anthos Investigate Site
    • São Paulo, Sao Paulo, Brazil, 08270-070
      • Anthos Investigate Site
    • Votuporanga, Sao Paulo, Brazil, 15500-003
      • Anthos Investigate Site
  • São Paulo
    • Marília, São Paulo, Brazil, 17515-000
      • Anthos Investigate Site
• Canada
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 0C2
      • Anthos Investigate Site
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Anthos Investigate Site
    • Oshawa, Ontario, Canada, L1J2K1
      • Anthos Investigate Site
    • Toronto, Ontario, Canada, M3N 3M5
      • Anthos Investigate Site
  • Quebec
    • Québec, Quebec, Canada, G1R 2J6
      • Anthos Investigate Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Anthos Investigate Site
• Czechia
  • Central Bohemian
    • Jinočany, Central Bohemian, Czechia, 25225
      • Anthos Investigate Site
  • Hradec Králové
    • Náchod, Hradec Králové, Czechia, 54701
      • Anthos Investigative Site
  • Karlovy Vary
    • Mariánské Lázně, Karlovy Vary, Czechia, 35301
      • Anthos Investigative Site
  • Královéhradecký Kraj
    • Trutnov, Královéhradecký Kraj, Czechia, 54101
      • Anthos Investigative Site
  • Lekarna BENU
    • Prague, Lekarna BENU, Czechia, 15800
      • Anthos Investigative Site
  • Praha 5
    • Praha, Praha 5, Czechia, 15006
      • Anthos Investigate Site
  • Praha 5 - Hlubocepy
    • Praha, Praha 5 - Hlubocepy, Czechia, 15200
      • Anthos Investigative Site
  • Ústí Nad Labem Region
    • Ústí Nad Labem, Ústí Nad Labem Region, Czechia, 40113
      • Anthos Investigative Site
• Germany
  • Berlin, Germany, 12621
    • Anthos Investigate Site
  • Bayern
    • Obermichelbach, Bayern, Germany, 90587
      • Anthos Investigative Site
  • Leipzig
    • Markkleeberg, Leipzig, Germany, 04416
      • Anthos Investigative Site
  • Ludwigshafen
    • Ludwigshafen am Rhein, Ludwigshafen, Germany, 67063
      • Anthos Investigate Site
  • Sachsen
    • Dresden, Sachsen, Germany, 1067
      • Anthos Investigate Site
  • Sächsische Schweiz-Osterzgebirge
    • Pirna, Sächsische Schweiz-Osterzgebirge, Germany, 01796
      • Anthos Investigative Site
• Hungary
  • Budapest, Hungary, 1088
    • Anthos Investigate Site
  • Hajdú-Bihar Megye
    • Debrecen, Hajdú-Bihar Megye, Hungary, 4032
      • Anthos Investigate Site
• Italy
  • Bologna, Italy, 40138
    • Anthos Investigate Site
  • Sesto San Giovanni, Italy, 20099
    • Anthos Investigate Site
  • Varese, Italy, 21100
    • Anthos Investigate Site
  • Campania
    • Napoli, Campania, Italy, 80131
      • Anthos Investigate Site
  • Lombardia
    • Milano, Lombardia, Italy, 20128
      • Anthos Investigate Site
  • Lombardy
    • Bergamo, Lombardy, Italy, 24127
      • Anthos Investigate Site
  • RM
    • Roma, RM, Italy, 168
      • Anthos Investigate Site
  • Umbria
    • Perugia, Umbria, Italy, 6156
      • Anthos Investigate Site
• Mexico
  • Mexico City, Mexico, 1120
    • Anthos Investigate Site
  • Querétaro, Mexico, 76000
    • Anthos Investigate Site
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • Anthos Investigate Site
  • Cuauhtemoc
    • Ciudad de mexico, Cuauhtemoc, Mexico, 6090
      • Anthos Investigate Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Anthos Investigate Site
  • Nuevo Leon
    • San Pedro Garza Garcia, Nuevo Leon, Mexico
      • Anthos Investigate Site
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80230
      • Anthos Investigate Site
• Poland
  • Warszawa, Poland, 04141
    • Anthos Investigate Site
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-518
      • Anthos Investigative Site
  • Mazovian
    • Warsaw, Mazovian, Poland, 02-097
      • Anthos Investigate Site
  • Małopolskie
    • Bochnia, Małopolskie, Poland, 32-700
      • Anthos Investigative Site
  • Ostrów Mazowiecka County
    • Ostrów Mazowiecka, Ostrów Mazowiecka County, Poland, 07-300
      • Anthos Investigative Site
  • Podkarpackie
    • Rzeszów, Podkarpackie, Poland, 35-055
      • Anthos Investigative Site
  • Podlaskie
    • Białystok, Podlaskie, Poland, 15-276
      • Anthos Investigate Site
    • Białystok, Podlaskie, Poland, 15-875
      • Anthos Investigative Site
  • Zach-pomorskie
    • Szczecin, Zach-pomorskie, Poland, 71-526
      • Anthos Investigate Site
  • Łódzkie Województwo
    • Łódź, Łódzkie Województwo, Poland, 94-046
      • Anthos Investigate Site
  • Łódź
    • Skierniewice, Łódź, Poland, 96-100
      • Anthos Investigative Site
  • Śląskie
    • Czeladź, Śląskie, Poland, 41-250
      • Anthos Investigative Site
• Spain
  • Madrid, Spain, 28046
    • Anthos Investigate Site
  • Barcelona
    • Sabadell, Barcelona, Spain, 8223
      • Anthos Investigate Site
  • Cabra
    • Córdoba, Cabra, Spain, 14940
      • Anthos Investigative Site
• United Kingdom
  • Middlesex, United Kingdom, TW7 6AF
    • Anthos Investigate Site
  • Cambridgeshite
    • Peterborough, Cambridgeshite, United Kingdom, PE3 9GZ
      • Anthos Investigate Site
  • Cornwall
    • Hayle, Cornwall, United Kingdom, TR27 5DT
      • Anthos Investigate Site
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR2 2TJ
      • Anthos Investigate Site
  • Northumberland
    • Ashington, Northumberland, United Kingdom, NE63 9JJ
      • Anthos Investigate Site
  • Tyne & Wear
    • Newcastle, Tyne & Wear, United Kingdom, NE7 7DN
      • Anthos Investigate Site
  • Vale Of Glamorgan
    • Barry, Vale Of Glamorgan, United Kingdom, CF63 1BA
      • Anthos Investigative Site
• United States
  • California
    • Fullerton, California, United States, 92831
      • Anthos Investigate Site
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Anthos Investigate Site
    • Homestead, Florida, United States, 33032
      • Anthos Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Anthos Investigate Site
    • Marietta, Georgia, United States, 30062
      • Anthos Investigate Site
  • Maryland
    • Lanham, Maryland, United States, 20706
      • Anthos Investigative Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Anthos Investigate Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Anthos Investigate Site
  • Texas
    • Tomball, Texas, United States, 77375
      • Anthos Investigate Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Anthos Therapeutics, Inc.
• Collaborators: CYTE Global

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Observational Study; Bleeding; Real-World Evidence; Systemic Thromboembolic Event
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ANT-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No