Global Anticoagulant Registry in the Field
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT01090362
- Lead Sponsor
- Thrombosis Research Institute
- Brief 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57250
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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death 4 years All cause mortality including cardiovascular and non-cardiovascular death
Stroke/Systemic embolism (SE) 4 years Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Major bleeding 4 years Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of โฅ2 g/dl, transfusion of โฅ2 units of packed red blood cells, or fatal outcome.
- Secondary Outcome Measures
Name Time Method Incidences of other clinical events 4 years Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Bleeding Events 4 years Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Cerebrovascular events defined as Stroke 4 years Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Transient Ischemic Attacks (TIA) 4 years Number of Transient Ischemic Attacks (TIA)
Acute coronary syndromes 4 years Number including unstable angina, STEMI, Non-STEMI
Therapy persistence 4 years Participant duration of time on therapy
Pulmonary Embolism 4 years Number of participants with a Pulmonary Embolism
Trial Locations
- Locations (35)
Professor Ali Oto, National Coordinating Investigator, Memorial Ankara Hospital
๐น๐ทAnkara, Turkey
Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile
๐จ๐ฑSantiago, Chile
Prof. Wael Al Mahmeed, National Coordinating Investigator, SKMC Cardiac Siences
๐ฆ๐ชAbu Dhabi, United Arab Emirates
Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universitรคt Graz
๐ฆ๐นGraz, Austria
Dr Frank Cools, National Co-ordinating Investigator, AZ Klina
๐ง๐ชBrasschaat, Belgium
Professor Hugo ten Cate, National Coordinating Investigator, Cardiovascular Research Institute Maastricht
๐ณ๐ฑMaastricht, Netherlands
Prof Joern Dalsgaard Nielsen, National Coordinating Investigator, Bispebjerg & Frederiksberg Hospitals
๐ฉ๐ฐFrederiksberg, Denmark
Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman
๐ฆ๐ทTucumรกn, Argentina
Prof. Samuel Goldhaber
๐บ๐ธBoston, Massachusetts, United States
Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital
๐ฆ๐บMelbourne, Australia
Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital
๐จ๐ฟPrague, Czechia
Dr Matyas Keltai, National Coordinating Investigator, Hungarian Institute of Cardiology
๐ญ๐บBudapest, Hungary
Dr Sawney, National Coordinating Investigator, Sir Ganga Ram Hospital, New Delhi
๐ฎ๐ณBangalore, India
Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,
๐ง๐ทSรฃo Paulo, Brazil
Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital
๐จ๐ณBeijing, China
Dr Carlos Jerjes Sanchez Diaz, National Coordinating Investigator,Tecnologico de Monterrey
๐ฒ๐ฝMonterrey, Mexico
Dr. Hany Ragy, National Coordinating Investigator, Hayat Hospital
๐ช๐ฌCairo, Egypt
Professor Yukihiro Koretsune, National Coordinating Investigator, Osaka National Hospital
๐ฏ๐ตOsaka, Japan
Prof. Seil Oh, National Coordinating Investigator, National University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Prof Harald Darius, National oordinating Investigator, Vivantes Klinikum Neukรถlln
๐ฉ๐ชBerlin, Germany
Prof Janina Stฤpiลska, National Coordinating Investigator, Institute of Cardiology, Warsaw
๐ต๐ฑWarsaw, Poland
Professor Dan Atar, National Coordinating Investigator, Oslo University Hospital
๐ณ๐ดOslo, Norway
Dr Toon Wei Lim, National Coordinating Investigator, National University Hospital
๐ธ๐ฌSingapore, Singapore
Dr Marten Rosenqvist, National Coordinating Investigator, Karolinska Institute
๐ธ๐ชStockholm, Sweden
Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand
๐ฟ๐ฆJohannesburg, South Africa
Dr Jan Steffel, National Coordinating Investigator, University Hospital
๐จ๐ญZurich, Switzerland
Prof. Pantep Angchaisuksiri, National Coordinating Investigator, Ramathibodi Hospital, Mahidol University
๐น๐ญBangkok, Thailand
Prof. Alexandr Parkhomenko, National Coordinating Investigator, Strazhesko Institute of Cardiology
๐บ๐ฆKiev, Ukraine
Profs Giancarlo Agnelli and Giuseppe Ambrosio, National Coordinating Investigators, University of Perugia
๐ฎ๐นPerugia, Italy
Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University
๐จ๐ฆHamilton, Canada
Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou
๐ซ๐ทParis, France
Prof Pekka Raatikainen, National Coordinating Investigator, Univesrsity of Tampere
๐ซ๐ฎTampere, Finland
Prof. David Fitzmaurice, National Coordinating Investigator, University of Warwick
๐ฌ๐งCoventry, United Kingdom
Dr Xavier Vinolas, National Coordinating Investigator, Hospital Santa Creu y San Pau
๐ช๐ธBarcelona, Spain
Professor Elizaveta Panchenko, National Coordinating Investigator, Cardiology Research and Production Center
๐ท๐บMoscow, Russian Federation