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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01090362
Other study ID # TRI08888
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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