Global Anticoagulant Registry in the Field

Atrial Fibrillation Clinical Trial

— GARFIELD-AF  

Official title:

Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090362
• Other study ID #: TRI08888
• Status: Completed
• Start date: December 21, 2009
• Est. completion date: May 18, 2020

Study information

• Verified date: April 2021
• Source: Thrombosis Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).

Description:

Using data from more than 1000 randomly selected centres across 35 countries, representing all possible care settings, the registry will help to characterize real-life anticoagulant treatment patterns and outcomes, including rates of stroke and bleeding complications, as well as provide data on other important issues, such as physicians' compliance with guidelines and patients' adherence to therapy. This is particularly timely as standard practice moves away from vitamin K antagonist (VKA)-dominated therapy and towards a new era of novel oral anticoagulants (OACs), i.e. direct Factor Xa inhibitors and direct thrombin inhibitors.

To ensure a dataset that truly reflects current practice, the investigators are requested to prospectively enrol all newly diagnosed patients with non-valvular AF who have at least one additional investigator-determined risk factor for stroke. Patients are consecutively recruited into one of five cohorts and followed up for at least 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57250
• Est. completion date: May 18, 2020
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Prospective Cohort

• Written informed consent

• Age 18 years and older

• New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one additional risk factor for stroke and regardless of therapy.

Retrospective validation cohort

• Written informed consent

• Age 18 years and older

• Diagnosis of non-valvular AF (diagnosed 6-24 months prior to enrolment) with at least one additional risk factor for stroke and regardless of therapy.

Exclusion criteria:

• No further follow-up envisaged or possible within enrolling hospital or with associated family practitioner.

• Patients with transient AF secondary to a reversible cause.

• Patients recruited in controlled clinical trials.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Argentina	Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman	Tucumán
Australia	Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital	Melbourne
Austria	Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz	Graz
Belgium	Dr Frank Cools, National Co-ordinating Investigator, AZ Klina	Brasschaat
Brazil	Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,	São Paulo
Canada	Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University	Hamilton
Chile	Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile	Santiago
China	Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital	Beijing
Czechia	Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital	Prague
Denmark	Prof Joern Dalsgaard Nielsen, National Coordinating Investigator, Bispebjerg & Frederiksberg Hospitals	Frederiksberg
Egypt	Dr. Hany Ragy, National Coordinating Investigator, Hayat Hospital	Cairo
Finland	Prof Pekka Raatikainen, National Coordinating Investigator, Univesrsity of Tampere	Tampere
France	Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou	Paris
Germany	Prof Harald Darius, National oordinating Investigator, Vivantes Klinikum Neukölln	Berlin
Hungary	Dr Matyas Keltai, National Coordinating Investigator, Hungarian Institute of Cardiology	Budapest
India	Dr Sawney, National Coordinating Investigator, Sir Ganga Ram Hospital, New Delhi	Bangalore
Italy	Profs Giancarlo Agnelli and Giuseppe Ambrosio, National Coordinating Investigators, University of Perugia	Perugia
Japan	Professor Yukihiro Koretsune, National Coordinating Investigator, Osaka National Hospital	Osaka
Korea, Republic of	Prof. Seil Oh, National Coordinating Investigator, National University Hospital	Seoul
Mexico	Dr Carlos Jerjes Sanchez Diaz, National Coordinating Investigator,Tecnologico de Monterrey	Monterrey
Netherlands	Professor Hugo ten Cate, National Coordinating Investigator, Cardiovascular Research Institute Maastricht	Maastricht
Norway	Professor Dan Atar, National Coordinating Investigator, Oslo University Hospital	Oslo
Poland	Prof Janina Stepinska, National Coordinating Investigator, Institute of Cardiology, Warsaw	Warsaw
Russian Federation	Professor Elizaveta Panchenko, National Coordinating Investigator, Cardiology Research and Production Center	Moscow
Singapore	Dr Toon Wei Lim, National Coordinating Investigator, National University Hospital	Singapore
South Africa	Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand	Johannesburg
Spain	Dr Xavier Vinolas, National Coordinating Investigator, Hospital Santa Creu y San Pau	Barcelona
Sweden	Dr Marten Rosenqvist, National Coordinating Investigator, Karolinska Institute	Stockholm
Switzerland	Dr Jan Steffel, National Coordinating Investigator, University Hospital	Zurich
Thailand	Prof. Pantep Angchaisuksiri, National Coordinating Investigator, Ramathibodi Hospital, Mahidol University	Bangkok
Turkey	Professor Ali Oto, National Coordinating Investigator, Memorial Ankara Hospital	Ankara
Ukraine	Prof. Alexandr Parkhomenko, National Coordinating Investigator, Strazhesko Institute of Cardiology	Kiev
United Arab Emirates	Prof. Wael Al Mahmeed, National Coordinating Investigator, SKMC Cardiac Siences	Abu Dhabi
United Kingdom	Prof. David Fitzmaurice, National Coordinating Investigator, University of Warwick	Coventry
United States	Prof. Samuel Goldhaber	Boston	Massachusetts

Sponsors (7)

Lead Sponsor	Collaborator
Thrombosis Research Institute	Advanced Drug and Device Services SAS, Apothecaries Clinical Research, Bayer, Brigham and Women's Hospital, Quintiles, Inc., University of Birmingham

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  Denmark,  Egypt,  Finland,  France,  Germany,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  Turkey,  Ukraine,  United Arab Emirates,  United Kingdom, 

References & Publications (4)

Aalbers J. GARFIELD: a window on the real-life treatment of atrial fibrillation - South Africa joins the GARFIELD registry. Cardiovasc J Afr. 2012 Oct;23(9):528. — View Citation

Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA; UK GARFIELD Investigators and GARFIELD Steering Committee. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc Disord. 2013 Apr 23;13:31. doi: 10.1186/1471-2261-13-31. — View Citation

Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and — View Citation

Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012 Jan;163(1):13-19.e1. doi: 10.1016/j.ahj.2011.09.011. Epub 2011 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	4 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	8 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	12 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	16 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	20 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	24 months
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	3 years
Primary	Death	All cause mortality including cardiovascular and non-cardiovascular death	4 years
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	4 months
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	8 months
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	12 months
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	16 months
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	20 months
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	24 months
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	3 years
Primary	Stroke/Systemic embolism (SE)	Stroke/SE was defined as the combined end points of ischemic stroke, and SE	4 years
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	4 months
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	8 months
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	12 months
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	16 months
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	20 months
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	24 months
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	3 years
Primary	Major bleeding	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of =2 g/dl, transfusion of =2 units of packed red blood cells, or fatal outcome.	4 years
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	4 months
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	8 months
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	12 months
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	16 months
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	20 months
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	24 months
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	3 years
Secondary	Cerebrovascular events defined as Stroke	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.	4 years
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	4 months
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	8 months
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	12 months
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	16 months
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	20 months
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	24 months
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	3 years
Secondary	Transient Ischemic Attacks (TIA)	Number of Transient Ischemic Attacks (TIA)	4 years
Secondary	Acute coronary syndromes	Number including unstable angina, STEMI, Non-STEMI	4 months
Secondary	Acute coronary syndromes	Number including unstable angina, STEMI, Non-STEMI	8 months
Secondary	Acute coronary syndromes	Number Including unstable angina, STEMI, Non-STEMI	12 months
Secondary	Acute coronary syndromes	Number including unstable angina, STEMI, Non-STEMI	16 months
Secondary	Acute coronary syndromes	Number including unstable angina, STEMI, Non-STEMI	20 months
Secondary	Acute coronary syndromes	Number including Unstable angina, STEMI, Non-STEMI	24 months
Secondary	Acute coronary syndromes	Number including unstable angina, STEMI, Non-STEMI	3 years
Secondary	Acute coronary syndromes	Number including unstable angina, STEMI, Non-STEMI	4 years
Secondary	Therapy persistence	Participant duration of time on therapy	4 months
Secondary	Therapy persistence	Participant duration of time on therapy	8 months
Secondary	Therapy persistence	Participant duration of time on therapy	12 months
Secondary	Therapy persistence	Participant duration of time on therapy	16 months
Secondary	Therapy persistence	Participant duration of time on therapy	20 months
Secondary	Therapy persistence	Participant duration of time on therapy	24 months
Secondary	Therapy persistence	Participant rate of discontinuation	3 years
Secondary	Therapy persistence	Participant duration of time on therapy	4 years
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	4 months
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	8 months
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	12 months
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	16 months
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	20 months
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	24 months
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	3 years
Secondary	Incidences of other clinical events	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)	4 years
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	4 months
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	8 months
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	12 months
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	16 months
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	20 months
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	24 months
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	3 years
Secondary	Bleeding Events	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event	4 years
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	4 months
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	8 months
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	12 months
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	16 months
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	20 months
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	24 months
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	3 years
Secondary	Pulmonary Embolism	Number of participants with a Pulmonary Embolism	4 years

External Links

•   Sponsor's website