Atrial FibrillationGARDENIANCT05421533
Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke
An observational study of Atrial Fibrillation, run by Anthos Therapeutics, Inc. at 96 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 705 participants
- Where
- 96 sitesin 12 countries
- Study dates
- 14 Sep 2022to 30 Sep 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
96 sites in 12 countries.
96 sites in 12 countries
Argentina17 sites
Anthos Investigate Site
Buenos Aires, Buenos Aires F.D., 1061
Anthos Investigate Site
Caba, Buenos Aires, 4102
Anthos Investigate Site
Córdoba, Córdoba Province, 5000
Anthos Investigate Site
Córdoba, 5000
Anthos Investigate Site
Coronel Suárez, Buenos Aires, 7540
Anthos Investigate Site
Corrientes, 3400
Anthos Investigate Site
Esperanza, Santa Fe Province, 3080
Anthos Investigate Site
Granadero Baigorria, Santa Fe Province, 2152
Anthos Investigate Site
La Plata, Buenos Aires, 1900
Anthos Investigate Site
Quilmes, Buenos Aires, 1878
Anthos Investigate Site
Ramos Mejía, Buenos Aires, B1704ETD
Anthos Investigate Site
Rosario, Santa Fe Province, 2000
Anthos Investigate Site
Salta, A4406BPF
Anthos Investigate Site
San Luis, 5700
Anthos Investigate Site
San Miguel de Tucumán, Tucumán Province, 4000
Anthos Investigate Site
San Nicolás de los Arroyos, Buenos Aires, 2900
Anthos Investigate Site
Santa Fe, 3000
Poland12 sites
Anthos Investigate Site
Bialystok, Podlaskie Voivodeship, 15-276
Anthos Investigative Site
Bialystok, Podlaskie Voivodeship, 15-875
Anthos Investigative Site
Bochnia, Lesser Poland Voivodeship, 32-700
Anthos Investigative Site
Czeladź, Silesian Voivodeship, 41-250
Anthos Investigate Site
Lodz, Łódzkie Województwo, 94-046
Anthos Investigative Site
Lublin, Lublin Voivodeship, 20-518
Anthos Investigative Site
Ostrów Mazowiecka, Ostrów Mazowiecka County, 07-300
Anthos Investigative Site
Rzeszów, Podkarpackie Voivodeship, 35-055
Anthos Investigative Site
Skierniewice, Łódź Voivodeship, 96-100
Anthos Investigate Site
Szczecin, Zach-pomorskie, 71-526
Anthos Investigate Site
Warsaw, Mazovian, 02-097
Anthos Investigate Site
Warsaw, 04141
Brazil11 sites
Anthos Investigate Site
Belo Horizonte, Minas Gerais, 30220-140
Anthos Investigate Site
Campina Grande do Sul, Paraná, 83430000
Anthos Investigate Site
Campo Grande, Mato Grosso do Sul, 79080-190
Anthos Investigate Site
Colatina, Espírito Santo, 29707-035
Anthos Investigate Site
Marília, São Paulo, 17515-000
Anthos Investigate Site
Passo Fundo, Rio Grande do Sul, 99010-080
Anthos Investigate Site
Porto Alegre, Rio Grande do Sul, 9041000
Anthos Investigate Site
Porto Alegre, Rio Grande do Sul, 90840440
Anthos Investigate Site
São Paulo, São Paulo, 05403
Anthos Investigate Site
São Paulo, São Paulo, 08270-070
Anthos Investigate Site
Votuporanga, São Paulo, 15500-003
United States9 sites
Anthos Investigate Site
Atlanta, Georgia, 30342
Anthos Investigate Site
Boca Raton, Florida, 33486
Anthos Investigate Site
Cary, North Carolina, 27518
Anthos Investigate Site
Detroit, Michigan, 48202
Anthos Investigate Site
Fullerton, California, 92831
Anthos Investigative Site
Homestead, Florida, 33032
Anthos Investigative Site
Lanham, Maryland, 20706
Anthos Investigate Site
Marietta, Georgia, 30062
Anthos Investigate Site
Tomball, Texas, 77375
Czechia8 sites
Anthos Investigate Site
Jinočany, Central Bohemian, 25225
Anthos Investigative Site
Mariánské Lázně, Karlovy Vary, 35301
Anthos Investigative Site
Náchod, Hradec Králové, 54701
Anthos Investigative Site
Prague, Lekarna BENU, 15800
Anthos Investigative Site
Prague, Praha 5 - Hlubocepy, 15200
Anthos Investigate Site
Prague, Praha 5, 15006
Anthos Investigative Site
Trutnov, Hradec Králové Region, 54101
Anthos Investigative Site
Ústí nad Labem, Ústí nad Labem Region, 40113
Italy8 sites
Anthos Investigate Site
Bergamo, Lombardy, 24127
Anthos Investigate Site
Bologna, 40138
Anthos Investigate Site
Milan, Lombardy, 20128
Anthos Investigate Site
Naples, Campania, 80131
Anthos Investigate Site
Perugia, Umbria, 6156
Anthos Investigate Site
Roma, RM, 168
Anthos Investigate Site
Sesto San Giovanni, 20099
Anthos Investigate Site
Varese, 21100
Mexico7 sites
Anthos Investigate Site
Culiacán, Sinaloa, 80230
Anthos Investigate Site
Guadalajara, Jalisco, 44670
Anthos Investigate Site
Mexico City, Cuauhtemoc, 6090
Anthos Investigate Site
Mexico City, 1120
Anthos Investigate Site
Querétaro, 76000
Anthos Investigate Site
San Pedro Garza García, Nuevo León
Anthos Investigate Site
Torreón, Coahuila, 27000
United Kingdom7 sites
Anthos Investigate Site
Ashington, Northumberland, NE63 9JJ
Anthos Investigative Site
Barry, Vale Of Glamorgan, CF63 1BA
Anthos Investigate Site
Hayle, Cornwall, TR27 5DT
Anthos Investigate Site
Middlesex, TW7 6AF
Anthos Investigate Site
Newcastle, Tyne & Wear, NE7 7DN
Anthos Investigate Site
Norwich, Norfolk, NR2 2TJ
Anthos Investigate Site
Peterborough, Cambridgeshite, PE3 9GZ
Canada6 sites
Anthos Investigate Site
Abbotsford British Columbia, British Columbia, V2S 0C2
Anthos Investigate Site
Newmarket, Ontario, L3Y 5G8
Anthos Investigate Site
Oshawa, Ontario, L1J2K1
Anthos Investigate Site
Québec, Quebec, G1R 2J6
Anthos Investigate Site
Sherbrooke, Quebec, J1H 5N4
Anthos Investigate Site
Toronto, Ontario, M3N 3M5
Germany6 sites
Anthos Investigate Site
Berlin, 12621
Anthos Investigate Site
Dresden, Saxony, 1067
Anthos Investigate Site
Ludwigshafen am Rhein, Ludwigshafen, 67063
Anthos Investigative Site
Markkleeberg, Leipzig, 04416
Anthos Investigative Site
Obermichelbach, Bavaria, 90587
Anthos Investigative Site
Pirna, Sächsische Schweiz-Osterzgebirge, 01796
Spain3 sites
Anthos Investigative Site
Córdoba, Cabra, 14940
Anthos Investigate Site
Madrid, 28046
Anthos Investigate Site
Sabadell, Barcelona, 8223
Hungary2 sites
Anthos Investigate Site
Budapest, 1088
Anthos Investigate Site
Debrecen, Hajdú-Bihar Megye, 4032
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Observational Study, Real-World Evidence, Atrial Fibrillation, Stroke, Bleeding, Systemic Thromboembolic Event
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start14 Sep 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: Concentration of resources on Phase 3 studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 705 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Anthos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CYTE Global
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421533
- Sponsor's protocol ID
- ANT-401
- Acronym
- GARDENIA
- Status last verified
- Nov 2024
- First submitted
- 6 Jun 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Prospective observationAl Study of Real-worlD managemEnt of patieNts With atrIal fibrillAtion at High Risk of Stroke (GARDENIA)
- ClinicalTrials.gov ID
- NCT05421533
- Acronym / sponsor ID
- GARDENIA / ANT-401
- Conditions
- Atrial Fibrillation
- Keywords
- Observational Study, Real-World Evidence, Atrial Fibrillation, Stroke, Bleeding, Systemic Thromboembolic Event
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Concentration of resources on Phase 3 studies
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Anthos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CYTE Global
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- Patients who are not treated with oral anticoagulants (only applies to the initial feasibility cohort)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of characteristics of patients with AF, including reasons anticoagulation is not used
Time frame: 24 Months
Information collected from physicians will provide the clinical reasons for treatment or nontreatment with OACs as assessed by the treating physicians
Bleeding
Time frame: 24 Months
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
Stroke and systemic embolic events
Time frame: 24 Months
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
Results and safety
The study was stopped early (reason given: Concentration of resources on Phase 3 studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
96 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Anthos Therapeutics, Inc. at 96 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in Argentina, Poland, Brazil, United States, Czechia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Concentration of resources on Phase 3 studies). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of characteristics of patients with AF, including reasons anticoagulation is not used (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.