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).
Brief Title
Global Anticoagulant Registry in the Field
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atrial Fibrillation
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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
Atrial fibrillation
Anticoagulation
Stroke
Stroke prevention
Health Economics
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01090362
Org Class
Other
Org Full Name
Thrombosis Research Institute
Org Study Id
TRI08888
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
Primary Outcomes
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
4 months
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
8 months
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
12 months
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
16 months
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
20 months
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
24 months
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
3 years
Outcome Description
All cause mortality including cardiovascular and non-cardiovascular death
Outcome Measure
Death
Outcome Time Frame
4 years
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
4 months
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
8 months
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
12 months
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
16 months
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
20 months
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
24 months
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
3 years
Outcome Description
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Outcome Measure
Stroke/Systemic embolism (SE)
Outcome Time Frame
4 years
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
4 months
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
8 months
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
12 months
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
16 months
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
20 months
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
24 months
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
3 years
Outcome Description
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.
Outcome Measure
Major bleeding
Outcome Time Frame
4 years
Secondary Outcomes
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
4 months
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
8 months
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
12 months
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
16 months
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
20 months
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
24 months
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
3 years
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Outcome Time Frame
4 years
Outcome Measure
Cerebrovascular events defined as Stroke
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
4 months
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
8 months
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
12 months
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
16 months
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
20 months
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
24 months
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
3 years
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number of Transient Ischemic Attacks (TIA)
Outcome Time Frame
4 years
Outcome Measure
Transient Ischemic Attacks (TIA)
Outcome Description
Number including unstable angina, STEMI, Non-STEMI
Outcome Time Frame
4 months
Outcome Measure
Acute coronary syndromes
Outcome Description
Number including unstable angina, STEMI, Non-STEMI
Outcome Time Frame
8 months
Outcome Measure
Acute coronary syndromes
Outcome Description
Number Including unstable angina, STEMI, Non-STEMI
Outcome Time Frame
12 months
Outcome Measure
Acute coronary syndromes
Outcome Description
Number including unstable angina, STEMI, Non-STEMI
Outcome Time Frame
16 months
Outcome Measure
Acute coronary syndromes
Outcome Description
Number including unstable angina, STEMI, Non-STEMI
Outcome Time Frame
20 months
Outcome Measure
Acute coronary syndromes
Outcome Description
Number including Unstable angina, STEMI, Non-STEMI
Outcome Time Frame
24 months
Outcome Measure
Acute coronary syndromes
Outcome Description
Number including unstable angina, STEMI, Non-STEMI
Outcome Time Frame
3 years
Outcome Measure
Acute coronary syndromes
Outcome Description
Number including unstable angina, STEMI, Non-STEMI
Outcome Time Frame
4 years
Outcome Measure
Acute coronary syndromes
Outcome Description
Participant duration of time on therapy
Outcome Time Frame
4 months
Outcome Measure
Therapy persistence
Outcome Description
Participant duration of time on therapy
Outcome Time Frame
8 months
Outcome Measure
Therapy persistence
Outcome Description
Participant duration of time on therapy
Outcome Time Frame
12 months
Outcome Measure
Therapy persistence
Outcome Description
Participant duration of time on therapy
Outcome Time Frame
16 months
Outcome Measure
Therapy persistence
Outcome Description
Participant duration of time on therapy
Outcome Time Frame
20 months
Outcome Measure
Therapy persistence
Outcome Description
Participant duration of time on therapy
Outcome Time Frame
24 months
Outcome Measure
Therapy persistence
Outcome Description
Participant rate of discontinuation
Outcome Time Frame
3 years
Outcome Measure
Therapy persistence
Outcome Description
Participant duration of time on therapy
Outcome Time Frame
4 years
Outcome Measure
Therapy persistence
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
4 months
Outcome Measure
Incidences of other clinical events
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
8 months
Outcome Measure
Incidences of other clinical events
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
12 months
Outcome Measure
Incidences of other clinical events
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
16 months
Outcome Measure
Incidences of other clinical events
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
20 months
Outcome Measure
Incidences of other clinical events
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
24 months
Outcome Measure
Incidences of other clinical events
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
3 years
Outcome Measure
Incidences of other clinical events
Outcome Description
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Outcome Time Frame
4 years
Outcome Measure
Incidences of other clinical events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
4 months
Outcome Measure
Bleeding Events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
8 months
Outcome Measure
Bleeding Events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
12 months
Outcome Measure
Bleeding Events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
16 months
Outcome Measure
Bleeding Events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
20 months
Outcome Measure
Bleeding Events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
24 months
Outcome Measure
Bleeding Events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
3 years
Outcome Measure
Bleeding Events
Outcome Description
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Outcome Time Frame
4 years
Outcome Measure
Bleeding Events
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
4 months
Outcome Measure
Pulmonary Embolism
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
8 months
Outcome Measure
Pulmonary Embolism
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
12 months
Outcome Measure
Pulmonary Embolism
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
16 months
Outcome Measure
Pulmonary Embolism
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
20 months
Outcome Measure
Pulmonary Embolism
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
24 months
Outcome Measure
Pulmonary Embolism
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
3 years
Outcome Measure
Pulmonary Embolism
Outcome Description
Number of participants with a Pulmonary Embolism
Outcome Time Frame
4 years
Outcome Measure
Pulmonary Embolism
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kevin Ferrick
Investigator Email
kferrick@montefiore.org
Investigator Phone
718-920-4293
Categories Mesh Debug
Heart/Cardiovascular --- ATRIAL FIBRILLATION
Brain, Spinal Cord & Nervous System --- STROKE
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
MeSH Terms
ATRIAL FIBRILLATION
STROKE
ARRHYTHMIAS, CARDIAC
HEART DISEASES
CARDIOVASCULAR DISEASES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
VASCULAR DISEASES