Clinical trial NCT01090362: Global Anticoagulant Registry in the Field
Official title: Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Anticoagulation
Stroke
Stroke prevention
Health Economics
Lead sponsor: Thrombosis Research Institute
Sponsor class: OTHER
Collaborators: name: Bayer
name: University of Birmingham
name: Brigham and Women's Hospital
name: Quintiles, Inc.
name: Advanced Drug and Device Services SAS
name: Apothecaries Clinical Research
First posted: 2010-03-19
Enrollment: 57250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients newly diagnosed with atrial fibrillation (AF) who are with at least one additional risk of stroke from 18 countries globally.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death
timeFrame: 4 months
measure: Death
timeFrame: 8 months
measure: Death
timeFrame: 12 months
measure: Death
timeFrame: 16 months
measure: Death
timeFrame: 20 months
measure: Death
timeFrame: 24 months
measure: Death
timeFrame: 3 years
measure: Death
timeFrame: 4 years
measure: Stroke/Systemic embolism (SE)
timeFrame: 4 months
measure: Stroke/Systemic embolism (SE)
timeFrame: 8 months
measure: Stroke/Systemic embolism (SE)
timeFrame: 12 months
measure: Stroke/Systemic embolism (SE)
timeFrame: 16 months
measure: Stroke/Systemic embolism (SE)
timeFrame: 20 months
measure: Stroke/Systemic embolism (SE)
timeFrame: 24 months
measure: Stroke/Systemic embolism (SE)
timeFrame: 3 years
measure: Stroke/Systemic embolism (SE)
timeFrame: 4 years
measure: Major bleeding
timeFrame: 4 months
measure: Major bleeding
timeFrame: 8 months
measure: Major bleeding
timeFrame: 12 months
measure: Major bleeding
timeFrame: 16 months
measure: Major bleeding
timeFrame: 20 months
measure: Major bleeding
timeFrame: 24 months
measure: Major bleeding
timeFrame: 3 years
measure: Major bleeding
timeFrame: 4 years
Secondary outcomes:
measure: Cerebrovascular events defined as Stroke
timeFrame: 4 months
measure: Cerebrovascular events defined as Stroke
timeFrame: 8 months
measure: Cerebrovascular events defined as Stroke
timeFrame: 12 months
measure: Cerebrovascular events defined as Stroke
timeFrame: 16 months
measure: Cerebrovascular events defined as Stroke
timeFrame: 20 months
measure: Cerebrovascular events defined as Stroke
timeFrame: 24 months
measure: Cerebrovascular events defined as Stroke
timeFrame: 3 years
measure: Cerebrovascular events defined as Stroke
timeFrame: 4 years
measure: Transient Ischemic Attacks (TIA)
timeFrame: 4 months
measure: Transient Ischemic Attacks (TIA)
timeFrame: 8 months
measure: Transient Ischemic Attacks (TIA)
timeFrame: 12 months
measure: Transient Ischemic Attacks (TIA)
timeFrame: 16 months
measure: Transient Ischemic Attacks (TIA)
timeFrame: 20 months
measure: Transient Ischemic Attacks (TIA)
timeFrame: 24 months
measure: Transient Ischemic Attacks (TIA)
timeFrame: 3 years
measure: Transient Ischemic Attacks (TIA)
timeFrame: 4 years
measure: Acute coronary syndromes
timeFrame: 4 months
measure: Acute coronary syndromes
timeFrame: 8 months
measure: Acute coronary syndromes
timeFrame: 12 months
measure: Acute coronary syndromes
timeFrame: 16 months
measure: Acute coronary syndromes
timeFrame: 20 months
measure: Acute coronary syndromes
timeFrame: 24 months
measure: Acute coronary syndromes
timeFrame: 3 years
measure: Acute coronary syndromes
timeFrame: 4 years
measure: Therapy persistence
timeFrame: 4 months
measure: Therapy persistence
timeFrame: 8 months
measure: Therapy persistence
timeFrame: 12 months
measure: Therapy persistence
timeFrame: 16 months
measure: Therapy persistence
timeFrame: 20 months
measure: Therapy persistence
timeFrame: 24 months
measure: Therapy persistence
timeFrame: 3 years
measure: Therapy persistence
timeFrame: 4 years
measure: Incidences of other clinical events
timeFrame: 4 months
measure: Incidences of other clinical events
timeFrame: 8 months
measure: Incidences of other clinical events
timeFrame: 12 months
measure: Incidences of other clinical events
timeFrame: 16 months
measure: Incidences of other clinical events
timeFrame: 20 months
measure: Incidences of other clinical events
timeFrame: 24 months
measure: Incidences of other clinical events
timeFrame: 3 years
measure: Incidences of other clinical events
timeFrame: 4 years
measure: Bleeding Events
timeFrame: 4 months
measure: Bleeding Events
timeFrame: 8 months
measure: Bleeding Events
timeFrame: 12 months
measure: Bleeding Events
timeFrame: 16 months
measure: Bleeding Events
timeFrame: 20 months
measure: Bleeding Events
timeFrame: 24 months
measure: Bleeding Events
timeFrame: 3 years
measure: Bleeding Events
timeFrame: 4 years
measure: Pulmonary Embolism
timeFrame: 4 months
measure: Pulmonary Embolism
timeFrame: 8 months
measure: Pulmonary Embolism
timeFrame: 12 months
measure: Pulmonary Embolism
timeFrame: 16 months
measure: Pulmonary Embolism
timeFrame: 20 months
measure: Pulmonary Embolism
timeFrame: 24 months
measure: Pulmonary Embolism
timeFrame: 3 years
measure: Pulmonary Embolism
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Prof. Samuel Goldhaber
state: Massachusetts
city: Tucumán
country: Argentina
facility: Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman
city: Melbourne
country: Australia
facility: Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital
city: Graz
country: Austria
facility: Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz
city: Brasschaat
country: Belgium
facility: Dr Frank Cools, National Co-ordinating Investigator, AZ Klina
city: São Paulo
country: Brazil
facility: Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,
city: Hamilton
country: Canada
facility: Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University
city: Santiago
country: Chile
facility: Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile
city: Beijing
country: China
facility: Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital
city: Prague
country: Czechia
facility: Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital
city: Frederiksberg
country: Denmark
facility: Prof Joern Dalsgaard Nielsen, National Coordinating Investigator, Bispebjerg & Frederiksberg Hospitals
city: Cairo
country: Egypt
facility: Dr. Hany Ragy, National Coordinating Investigator, Hayat Hospital
city: Tampere
country: Finland
facility: Prof Pekka Raatikainen, National Coordinating Investigator, Univesrsity of Tampere
city: Paris
country: France
facility: Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou
city: Berlin
country: Germany
facility: Prof Harald Darius, National oordinating Investigator, Vivantes Klinikum Neukölln
city: Budapest
country: Hungary
facility: Dr Matyas Keltai, National Coordinating Investigator, Hungarian Institute of Cardiology
city: Bangalore
country: India
facility: Dr Sawney, National Coordinating Investigator, Sir Ganga Ram Hospital, New Delhi
city: Perugia
country: Italy
facility: Profs Giancarlo Agnelli and Giuseppe Ambrosio, National Coordinating Investigators, University of Perugia
city: Osaka
country: Japan
facility: Professor Yukihiro Koretsune, National Coordinating Investigator, Osaka National Hospital
city: Seoul
country: Korea, Republic of
facility: Prof. Seil Oh, National Coordinating Investigator, National University Hospital
city: Monterrey
country: Mexico
facility: Dr Carlos Jerjes Sanchez Diaz, National Coordinating Investigator,Tecnologico de Monterrey
city: Maastricht
country: Netherlands
facility: Professor Hugo ten Cate, National Coordinating Investigator, Cardiovascular Research Institute Maastricht
city: Oslo
country: Norway
facility: Professor Dan Atar, National Coordinating Investigator, Oslo University Hospital
city: Warsaw
country: Poland
facility: Prof Janina Stępińska, National Coordinating Investigator, Institute of Cardiology, Warsaw
city: Moscow
country: Russian Federation
facility: Professor Elizaveta Panchenko, National Coordinating Investigator, Cardiology Research and Production Center
city: Singapore
country: Singapore
facility: Dr Toon Wei Lim, National Coordinating Investigator, National University Hospital
city: Johannesburg
country: South Africa
facility: Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand
city: Barcelona
country: Spain
facility: Dr Xavier Vinolas, National Coordinating Investigator, Hospital Santa Creu y San Pau
city: Stockholm
country: Sweden
facility: Dr Marten Rosenqvist, National Coordinating Investigator, Karolinska Institute
city: Zurich
country: Switzerland
facility: Dr Jan Steffel, National Coordinating Investigator, University Hospital
city: Bangkok
country: Thailand
facility: Prof. Pantep Angchaisuksiri, National Coordinating Investigator, Ramathibodi Hospital, Mahidol University
city: Ankara
country: Turkey
facility: Professor Ali Oto, National Coordinating Investigator, Memorial Ankara Hospital
city: Kiev
country: Ukraine
facility: Prof. Alexandr Parkhomenko, National Coordinating Investigator, Strazhesko Institute of Cardiology
city: Abu Dhabi
country: United Arab Emirates
facility: Prof. Wael Al Mahmeed, National Coordinating Investigator, SKMC Cardiac Siences
city: Coventry
country: United Kingdom
facility: Prof. David Fitzmaurice, National Coordinating Investigator, University of Warwick
Study officials:
affiliation: Thrombosis Research Institute, London, UK
name: Ajay K Kakkar
role: STUDY_DIRECTOR
References:
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