Clinical trial NCT05421533: Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke
Official title: A Global Prospective observationAl Study of Real-worlD managemEnt of patieNts With atrIal fibrillAtion at High Risk of Stroke (GARDENIA)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Keywords: Observational Study
Real-World Evidence
Atrial Fibrillation
Stroke
Bleeding
Systemic Thromboembolic Event
Lead sponsor: Anthos Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CYTE Global
First posted: 2022-06-16
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Distribution of characteristics of patients with AF, including reasons anticoagulation is not used
timeFrame: 24 Months
measure: Bleeding
timeFrame: 24 Months
measure: Stroke and systemic embolic events
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Anthos Investigate Site
state: California
city: Boca Raton
country: United States
facility: Anthos Investigate Site
state: Florida
city: Homestead
country: United States
facility: Anthos Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Anthos Investigate Site
state: Georgia
city: Marietta
country: United States
facility: Anthos Investigate Site
state: Georgia
city: Lanham
country: United States
facility: Anthos Investigative Site
state: Maryland
city: Detroit
country: United States
facility: Anthos Investigate Site
state: Michigan
city: Cary
country: United States
facility: Anthos Investigate Site
state: North Carolina
city: Tomball
country: United States
facility: Anthos Investigate Site
state: Texas
city: Caba
country: Argentina
facility: Anthos Investigate Site
state: Buenos Aires
city: Coronel Suárez
country: Argentina
facility: Anthos Investigate Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Anthos Investigate Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Anthos Investigate Site
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: Anthos Investigate Site
state: Buenos Aires
city: San Nicolas de los Arroyos
country: Argentina
facility: Anthos Investigate Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Anthos Investigate Site
state: Caba
city: Córdoba
country: Argentina
facility: Anthos Investigate Site
state: Cordoba
city: Esperanza
country: Argentina
facility: Anthos Investigate Site
state: Santa Fe
city: Granadero Baigorria
country: Argentina
facility: Anthos Investigate Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Anthos Investigate Site
state: Santa Fe
city: Tucumán
country: Argentina
facility: Anthos Investigate Site
state: Tucuman
city: Cordoba
country: Argentina
facility: Anthos Investigate Site
city: Corrientes
country: Argentina
facility: Anthos Investigate Site
city: Salta
country: Argentina
facility: Anthos Investigate Site
city: San Luis
country: Argentina
facility: Anthos Investigate Site
city: Santa Fe
country: Argentina
facility: Anthos Investigate Site
city: Colatina
country: Brazil
facility: Anthos Investigate Site
state: Espírito Santo
city: Campo Grande
country: Brazil
facility: Anthos Investigate Site
state: Mato Grosso Do Sul
city: Belo Horizonte
country: Brazil
facility: Anthos Investigate Site
state: Minas Gerais
city: Campina Grande Do Sul
country: Brazil
facility: Anthos Investigate Site
state: Parana
city: Passo Fundo
country: Brazil
facility: Anthos Investigate Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Anthos Investigate Site
state: RS
city: Porto Alegre
country: Brazil
facility: Anthos Investigate Site
state: RS
city: São Paulo
country: Brazil
facility: Anthos Investigate Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Anthos Investigate Site
state: Sao Paulo
city: Votuporanga
country: Brazil
facility: Anthos Investigate Site
state: Sao Paulo
city: Marília
country: Brazil
facility: Anthos Investigate Site
state: São Paulo
city: Abbotsford
country: Canada
facility: Anthos Investigate Site
state: British Columbia
city: Newmarket
country: Canada
facility: Anthos Investigate Site
state: Ontario
city: Oshawa
country: Canada
facility: Anthos Investigate Site
state: Ontario
city: Toronto
country: Canada
facility: Anthos Investigate Site
state: Ontario
city: Québec
country: Canada
facility: Anthos Investigate Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Anthos Investigate Site
state: Quebec
city: Jinočany
country: Czechia
facility: Anthos Investigate Site
state: Central Bohemian
city: Náchod
country: Czechia
facility: Anthos Investigative Site
state: Hradec Králové
city: Mariánské Lázně
country: Czechia
facility: Anthos Investigative Site
state: Karlovy Vary
city: Trutnov
country: Czechia
facility: Anthos Investigative Site
state: Královéhradecký Kraj
city: Prague
country: Czechia
facility: Anthos Investigative Site
state: Lekarna BENU
city: Praha
country: Czechia
facility: Anthos Investigative Site
state: Praha 5 - Hlubocepy
city: Praha
country: Czechia
facility: Anthos Investigate Site
state: Praha 5
city: Ústí Nad Labem
country: Czechia
facility: Anthos Investigative Site
state: Ústí Nad Labem Region
city: Obermichelbach
country: Germany
facility: Anthos Investigative Site
state: Bayern
city: Markkleeberg
country: Germany
facility: Anthos Investigative Site
state: Leipzig
city: Ludwigshafen am Rhein
country: Germany
facility: Anthos Investigate Site
state: Ludwigshafen
city: Dresden
country: Germany
facility: Anthos Investigate Site
state: Sachsen
city: Pirna
country: Germany
facility: Anthos Investigative Site
state: Sächsische Schweiz-Osterzgebirge
city: Berlin
country: Germany
facility: Anthos Investigate Site
city: Debrecen
country: Hungary
facility: Anthos Investigate Site
state: Hajdú-Bihar Megye
city: Budapest
country: Hungary
facility: Anthos Investigate Site
city: Napoli
country: Italy
facility: Anthos Investigate Site
state: Campania
city: Milano
country: Italy
facility: Anthos Investigate Site
state: Lombardia
city: Bergamo
country: Italy
facility: Anthos Investigate Site
state: Lombardy
city: Roma
country: Italy
facility: Anthos Investigate Site
state: RM
city: Perugia
country: Italy
facility: Anthos Investigate Site
state: Umbria
city: Bologna
country: Italy
facility: Anthos Investigate Site
city: Sesto San Giovanni
country: Italy
facility: Anthos Investigate Site
city: Varese
country: Italy
facility: Anthos Investigate Site
city: Torreon
country: Mexico
facility: Anthos Investigate Site
state: Coahuila
city: Ciudad de mexico
country: Mexico
facility: Anthos Investigate Site
state: Cuauhtemoc
city: Guadalajara
country: Mexico
facility: Anthos Investigate Site
state: Jalisco
city: San Pedro Garza Garcia
country: Mexico
facility: Anthos Investigate Site
state: Nuevo Leon
city: Culiacán
country: Mexico
facility: Anthos Investigate Site
state: Sinaloa
city: Mexico City
country: Mexico
facility: Anthos Investigate Site
city: Querétaro
country: Mexico
facility: Anthos Investigate Site
city: Lublin
country: Poland
facility: Anthos Investigative Site
state: Lubelskie
city: Warsaw
country: Poland
facility: Anthos Investigate Site
state: Mazovian
city: Bochnia
country: Poland
facility: Anthos Investigative Site
state: Małopolskie
city: Ostrów Mazowiecka
country: Poland
facility: Anthos Investigative Site
state: Ostrów Mazowiecka County
city: Rzeszów
country: Poland
facility: Anthos Investigative Site
state: Podkarpackie
city: Białystok
country: Poland
facility: Anthos Investigate Site
state: Podlaskie
city: Białystok
country: Poland
facility: Anthos Investigative Site
state: Podlaskie
city: Szczecin
country: Poland
facility: Anthos Investigate Site
state: Zach-pomorskie
city: Warszawa
country: Poland
facility: Anthos Investigate Site
city: Łódź
country: Poland
facility: Anthos Investigate Site
state: Łódzkie Województwo
city: Skierniewice
country: Poland
facility: Anthos Investigative Site
state: Łódź
city: Czeladź
country: Poland
facility: Anthos Investigative Site
state: Śląskie
city: Sabadell
country: Spain
facility: Anthos Investigate Site
state: Barcelona
city: Córdoba
country: Spain
facility: Anthos Investigative Site
state: Cabra
city: Madrid
country: Spain
facility: Anthos Investigate Site
city: Peterborough
country: United Kingdom
facility: Anthos Investigate Site
state: Cambridgeshite
city: Hayle
country: United Kingdom
facility: Anthos Investigate Site
state: Cornwall
city: Norwich
country: United Kingdom
facility: Anthos Investigate Site
state: Norfolk
city: Ashington
country: United Kingdom
facility: Anthos Investigate Site
state: Northumberland
city: Newcastle
country: United Kingdom
facility: Anthos Investigate Site
state: Tyne & Wear
city: Barry
country: United Kingdom
facility: Anthos Investigative Site
state: Vale Of Glamorgan
city: Middlesex
country: United Kingdom
facility: Anthos Investigate Site
Study officials:
References: