Global Anticoagulant Registry in the Field

Study Overview
=================
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.

Official Title
-----------------
Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Cohort complete with 5,088 retrospective patients and 5,499 prospective patients recruited from 19 countries. | |
| Cohort 2<br>Cohort completed with 11,351 patients enrolled from 30 countries | |
| Cohort 3<br>Cohort 3 completed with 11,139 patients enrolled globally from 32 countries | |
| Cohort 4<br>Cohort 4 completed with 11,2780 patients enrolled from 35 countries. | |
| Cohort 5<br>Final cohort completed with 12,186 patients enrolled. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 4 months | 
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 8 months | 
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 12 months | 
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 16 months | 
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 20 months | 
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 24 months | 
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 3 years | 
| Death | All cause mortality including cardiovascular and non-cardiovascular death | 4 years | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 4 months | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 8 months | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 12 months | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 16 months | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 20 months | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 24 months | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 3 years | 
| Stroke/Systemic embolism (SE) | Stroke/SE was defined as the combined end points of ischemic stroke, and SE | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 4 months | 
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 8 months | 
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 12 months | 
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 16 months | 
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 20 months | 
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 24 months | 
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 3 years | 
| Cerebrovascular events defined as Stroke | Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke. | 4 years | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 4 months | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 8 months | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 12 months | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 16 months | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 20 months | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 24 months | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 3 years | 
| Transient Ischemic Attacks (TIA) | Number of Transient Ischemic Attacks (TIA) | 4 years | 
| Acute coronary syndromes | Number including unstable angina, STEMI, Non-STEMI | 4 months | 
| Acute coronary syndromes | Number including unstable angina, STEMI, Non-STEMI | 8 months | 
| Acute coronary syndromes | Number Including unstable angina, STEMI, Non-STEMI | 12 months | 
| Acute coronary syndromes | Number including unstable angina, STEMI, Non-STEMI | 16 months | 
| Acute coronary syndromes | Number including unstable angina, STEMI, Non-STEMI | 20 months | 
| Acute coronary syndromes | Number including Unstable angina, STEMI, Non-STEMI | 24 months | 
| Acute coronary syndromes | Number including unstable angina, STEMI, Non-STEMI | 3 years | 
| Acute coronary syndromes | Number including unstable angina, STEMI, Non-STEMI | 4 years | 
| Therapy persistence | Participant duration of time on therapy | 4 months | 
| Therapy persistence | Participant duration of time on therapy | 8 months | 
| Therapy persistence | Participant duration of time on therapy | 12 months | 
| Therapy persistence | Participant duration of time on therapy | 16 months | 
| Therapy persistence | Participant duration of time on therapy | 20 months | 
| Therapy persistence | Participant duration of time on therapy | 24 months | 
| Therapy persistence | Participant rate of discontinuation | 3 years | 
| Therapy persistence | Participant duration of time on therapy | 4 years | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 4 months | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 8 months | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 12 months | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 16 months | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 20 months | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 24 months | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 3 years | 
| Incidences of other clinical events | Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF) | 4 years | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 4 months | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 8 months | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 12 months | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 16 months | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 20 months | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 24 months | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 3 years | 
| Bleeding Events | Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event | 4 years | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 4 months | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 8 months | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 12 months | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 16 months | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 20 months | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 24 months | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 3 years | 
| Pulmonary Embolism | Number of participants with a Pulmonary Embolism | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Anticoagulation, Stroke, Stroke prevention, Health Economics