Global Anticoagulant Registry in the Field

Thrombosis Research Institute57,250 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

57,250

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (35)

Outcomes

Primary Outcomes

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 4 months

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 8 months

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 12 months

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 16 months

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 20 months

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 24 months

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 3 years

Death

All cause mortality including cardiovascular and non-cardiovascular death

Time frame: 4 years

Stroke/Systemic embolism (SE)

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 4 months

Stroke/Systemic embolism (SE)

Data from ClinicalTrials.gov

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Prof. Samuel Goldhaber

Boston, Massachusetts, United States

Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman

San Miguel de Tucumán, Argentina

Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital

Melbourne, Australia

Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz

Graz, Austria

Dr Frank Cools, National Co-ordinating Investigator, AZ Klina

Brasschaat, Belgium

Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,

São Paulo, Brazil

Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University

Hamilton, Canada

Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile

Santiago, Chile

Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital

Beijing, China

Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital

Prague, Czechia

...and 25 more locations

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 8 months

Stroke/Systemic embolism (SE)

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 12 months

Stroke/Systemic embolism (SE)

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 16 months

Stroke/Systemic embolism (SE)

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 20 months

Stroke/Systemic embolism (SE)

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 24 months

Stroke/Systemic embolism (SE)

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 3 years

Stroke/Systemic embolism (SE)

Stroke/SE was defined as the combined end points of ischemic stroke, and SE

Time frame: 4 years

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.

Time frame: 4 months

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.

Time frame: 8 months

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.

Time frame: 12 months

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.

Time frame: 16 months

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.

Time frame: 20 months

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.

Time frame: 24 months

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.

Time frame: 3 years

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.

Time frame: 4 years