Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Anticoagulation, Stroke, Stroke prevention, Health Economics
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.
Interventions
None listed
Sponsors
Bayer
University of Birmingham
Brigham and Women's Hospital
Quintiles, Inc.
Advanced Drug and Device Services SAS
Apothecaries Clinical Research
Thrombosis Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | 4 months | All cause mortality including cardiovascular and non-cardiovascular death |
| Stroke/Systemic embolism (SE) | 4 months | Stroke/SE was defined as the combined end points of ischemic stroke, and SE |
| Major bleeding | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapy persistence | 4 months | Participant duration of time on therapy |
| Incidences of other clinical events | 4 months | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) |
| Cerebrovascular events defined as Stroke | 4 months | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. |
| Pulmonary Embolism | 4 months | Number of participants with a Pulmonary Embolism |
| Bleeding Events | 4 months | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event |
| Transient Ischemic Attacks (TIA) | 4 months | Number of Transient Ischemic Attacks (TIA) |
| Acute coronary syndromes | 4 months | Number including unstable angina, STEMI, Non-STEMI |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Egypt, Finland, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom, United States
Outcome results
None listed