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

Atrial Fibrillation Clinical Trial

— GARDENIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421533
• Other study ID #: ANT-401
• Status: Recruiting
• Start date: September 14, 2022
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Anthos Therapeutics, Inc.
• Contact: CYTE Global
• Phone: 02031989914
• Email: Contact[@]cyteglobal.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Argentina	Anthos Investigate Site	Buenos Aires	Caba
Argentina	Anthos Investigate Site	Caba	Buenos Aires
Argentina	Anthos Investigate Site	Cordoba
Argentina	Anthos Investigate Site	Córdoba	Cordoba
Argentina	Anthos Investigate Site	Coronel Suárez	Buenos Aires
Argentina	Anthos Investigate Site	Corrientes
Argentina	Anthos Investigate Site	Esperanza	Santa Fe
Argentina	Anthos Investigate Site	Granadero Baigorria	Santa Fe
Argentina	Anthos Investigate Site	La Plata	Buenos Aires
Argentina	Anthos Investigate Site	Quilmes	Buenos Aires
Argentina	Anthos Investigate Site	Ramos Mejía	Buenos Aires
Argentina	Anthos Investigate Site	Rosario	Santa Fe
Argentina	Anthos Investigate Site	Rosario	Santa Fe
Argentina	Anthos Investigate Site	Salta
Argentina	Anthos Investigate Site	San Luis
Argentina	Anthos Investigate Site	San Nicolas de los Arroyos	Buenos Aires
Argentina	Anthos Investigate Site	Santa Fe
Argentina	Anthos Investigate Site	Tucumán	Tucuman
Brazil	Anthos Investigate Site	Belo Horizonte	Minas Gerais
Brazil	Anthos Investigate Site	Belo Horizonte	Minas Gerais
Brazil	Anthos Investigate Site	Campina Grande Do Sul	Parana
Brazil	Anthos Investigate Site	Campo Grande	Mato Grosso Do Sul
Brazil	Anthos Investigate Site	Colatina	Espírito Santo
Brazil	Anthos Investigate Site	Garcia	Blumenau/SC
Brazil	Anthos Investigate Site	Marília	São Paulo
Brazil	Anthos Investigate Site	Passo Fundo	Rio Grande Do Sul
Brazil	Anthos Investigate Site	Porto Alegre	Rio Grande Do Sul
Brazil	Anthos Investigate Site	Porto Alegre	Rio Grande Do Sul
Brazil	Anthos Investigate Site	Porto Alegre	RS
Brazil	Anthos Investigate Site	Porto Alegre	RS
Brazil	Anthos Investigate Site	Recife	Pernambuco
Brazil	Anthos Investigate Site	Ribeirao Preto	Sao Paulo
Brazil	Anthos Investigate Site	Salvador	Bahia
Brazil	Anthos Investigate Site	São José Do Rio Preto	São Paulo
Brazil	Anthos Investigate Site	São Paulo
Brazil	Anthos Investigate Site	São Paulo
Brazil	Anthos Investigate Site	São Paulo	Sao Paulo
Brazil	Anthos Investigate Site	São Paulo	Sao Paulo
Brazil	Anthos Investigate Site	São Paulo	Sao Paulo
Brazil	Anthos Investigate Site	São Paulo	Sao Paulo
Brazil	Anthos Investigate Site	Teresina	Piauí
Brazil	Anthos Investigate Site	Votuporanga	Sao Paulo
Canada	Anthos Investigate Site	Abbotsford	British Columbia
Canada	Anthos Investigate Site	Brampton	Ontario
Canada	Anthos Investigate Site	Cambridge	Ontario
Canada	Anthos Investigate Site	Halifax	Nova Scotia
Canada	Anthos Investigate Site	Newmarket	Ontario
Canada	Anthos Investigate Site	Oakville	Ontario
Canada	Anthos Investigate Site	Oshawa	Ontario
Canada	Anthos Investigate Site	Peterborough	Ontario
Canada	Anthos Investigate Site	Québec	Quebec
Canada	Anthos Investigate Site	Sherbrooke	Quebec
Canada	Anthos Investigate Site	Toronto	Ontario
Canada	Anthos Investigate Site	Toronto	Ontario
Czechia	Anthos Investigate Site	Jinocany	Central Bohemian
Czechia	Anthos Investigative Site	Mariánské Lázne	Karlovy Vary
Czechia	Anthos Investigative Site	Náchod	Hradec Králové
Czechia	Anthos Investigative Site	Prague	Lekarna BENU
Czechia	Anthos Investigate Site	Praha	Praha 5
Czechia	Anthos Investigative Site	Praha	Praha 5 - Hlubocepy
Czechia	Anthos Investigative Site	Trutnov	Královéhradecký Kraj
Czechia	Anthos Investigative Site	Ústí Nad Labem	Ústí Nad Labem Region
Germany	Anthos Investigate Site	Berlin
Germany	Anthos Investigate Site	Dresden	Sachsen
Germany	Anthos Investigate Site	Gräfenhainichen	Sachsen Anhalt
Germany	Anthos Investigate Site	Ludwigshafen
Germany	Anthos Investigate Site	Ludwigshafen am Rhein	Ludwigshafen
Germany	Anthos Investigative Site	Markkleeberg	Leipzig
Germany	Anthos Investigative Site	Obermichelbach	Bayern
Germany	Anthos Investigative Site	Pirna	Sächsische Schweiz-Osterzgebirge
Germany	Anthos Investigative Site	Zwenkau	Leipzig
Hungary	Anthos Investigate Site	Budapest
Hungary	Anthos Investigate Site	Debrecen	Hajdú-Bihar Megye
Hungary	Anthos Investigate Site	Mosonmagyaróvár	Gyor-Moson-Sopron
Hungary	Anthos Investigate Site	Seregélyes	Szekesfehervar
Italy	Anthos Investigate Site	Bergamo	Lombardy
Italy	Anthos Investigate Site	Bologna
Italy	Anthos Investigate Site	Catanzaro
Italy	Anthos Investigate Site	Milano	Lombardia
Italy	Anthos Investigate Site	Napoli	Campania
Italy	Anthos Investigate Site	Perugia	Umbria
Italy	Anthos Investigate Site	Roma	RM
Italy	Anthos Investigate Site	Rozzano	MI
Italy	Anthos Investigate Site	Sesto San Giovanni
Italy	Anthos Investigate Site	Varese
Mexico	Anthos Investigate Site	Aguascalientes
Mexico	Anthos Investigate Site	Ciudad de mexico	Cuauhtemoc
Mexico	Anthos Investigate Site	Culiacán	Sinaloa
Mexico	Anthos Investigate Site	Guadalajara	Jalisco
Mexico	Anthos Investigate Site	Mexico City
Mexico	Anthos Investigate Site	Monterrey	Nuevo Leon
Mexico	Anthos Investigate Site	Querétaro
Mexico	Anthos Investigate Site	San Pedro Garza Garcia	Nuevo Leon
Mexico	Anthos Investigate Site	Torreon	Coahuila
Mexico	Anthos Investigate Site	Veracruz
Mexico	Anthos Investigate Site	Zapopan	Jalisco
Poland	Anthos Investigate Site	Bialystok	Podlaskie
Poland	Anthos Investigative Site	Bialystok	Podlaskie
Poland	Anthos Investigative Site	Bochnia	Malopolskie
Poland	Anthos Investigative Site	Czeladz	Slaskie
Poland	Anthos Investigate Site	Lódz	Lódzkie Województwo
Poland	Anthos Investigative Site	Lublin	Lubelskie
Poland	Anthos Investigative Site	Ostrów Mazowiecka	Ostrów Mazowiecka County
Poland	Anthos Investigative Site	Rzeszów	Podkarpackie
Poland	Anthos Investigative Site	Skierniewice	Lódz
Poland	Anthos Investigate Site	Szczecin	Zach-pomorskie
Poland	Anthos Investigate Site	Warsaw	Mazovian
Poland	Anthos Investigative Site	Warsaw	Kosciusko County
Poland	Anthos Investigate Site	Warszawa
Spain	Anthos Investigative Site	Córdoba	Cabra
Spain	Anthos Investigate Site	Granada
Spain	Anthos Investigate Site	Madrid
Spain	Anthos Investigate Site	Sabadell	Barcelona
United Kingdom	Anthos Investigate Site	Ashington	Northumberland
United Kingdom	Anthos Investigative Site	Barry	Vale Of Glamorgan
United Kingdom	Anthos Investigate Site	Basingstoke	Hampshire
United Kingdom	Anthos Investigate Site	Corby	Northamptonshire
United Kingdom	Anthos Investigate Site	Exeter	Devon
United Kingdom	Anthos Investigate Site	Hayle	Cornwall
United Kingdom	Anthos Investigate Site	Hitchin	Hertfordshire
United Kingdom	Anthos Investigate Site	Leicester	Leicestershite
United Kingdom	Anthos Investigate Site	Middlesex
United Kingdom	Anthos Investigate Site	Newcastle	Tyne & Wear
United Kingdom	Anthos Investigate Site	Norwich	Norfolk
United Kingdom	Anthos Investigate Site	Peterborough	Cambridgeshite
United Kingdom	Anthos Investigate Site	Taunton	Somerset
United States	Anthos Investigate Site	Atlanta	Georgia
United States	Anthos Investigative Site	Boca Raton	Florida
United States	Anthos Investigate Site	Cary	North Carolina
United States	Anthos Investigate Site	Detroit	Michigan
United States	Anthos Investigate Site	Fullerton	California
United States	Anthos Investigative Site	Homestead	Florida
United States	Anthos Investigative Site	Jamaica	New York
United States	Anthos Investigative Site	Lanham	Maryland
United States	Anthos Investigate Site	Macon	Georgia
United States	Anthos Investigate Site	Marietta	Georgia
United States	Anthos Investigate Site	Miami	Florida
United States	Anthos Investigate Site	Tomball	Texas
United States	Anthos Investigate Site	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Anthos Therapeutics, Inc.	CYTE Global

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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