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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01090362
Registration number
NCT01090362
Ethics application status
Date submitted
18/03/2010
Date registered
19/03/2010
Date last updated
28/04/2021
Titles & IDs
Public title
Global Anticoagulant Registry in the Field
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Scientific title
Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
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Secondary ID [1]
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TRI08888
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Universal Trial Number (UTN)
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Trial acronym
GARFIELD-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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0
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Condition category
Condition code
Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Cohort 1 - Cohort complete with 5,088 retrospective patients and 5,499 prospective patients recruited from 19 countries.
Cohort 2 - Cohort completed with 11,351 patients enrolled from 30 countries
Cohort 3 - Cohort 3 completed with 11,139 patients enrolled globally from 32 countries
Cohort 4 - Cohort 4 completed with 11,2780 patients enrolled from 35 countries.
Cohort 5 - Final cohort completed with 12,186 patients enrolled.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death
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Assessment method [1]
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All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [1]
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4 months
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Primary outcome [2]
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0
Death
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Assessment method [2]
0
0
All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [2]
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0
8 months
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Primary outcome [3]
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0
Death
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Assessment method [3]
0
0
All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [3]
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0
12 months
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Primary outcome [4]
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0
Death
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Assessment method [4]
0
0
All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [4]
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0
16 months
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Primary outcome [5]
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0
Death
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Assessment method [5]
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0
All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [5]
0
0
20 months
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Primary outcome [6]
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0
Death
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Assessment method [6]
0
0
All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [6]
0
0
24 months
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Primary outcome [7]
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0
Death
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Assessment method [7]
0
0
All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [7]
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0
3 years
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Primary outcome [8]
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0
Death
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Assessment method [8]
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0
All cause mortality including cardiovascular and non-cardiovascular death
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Timepoint [8]
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0
4 years
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Primary outcome [9]
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0
Stroke/Systemic embolism (SE)
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Assessment method [9]
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0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [9]
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4 months
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Primary outcome [10]
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0
Stroke/Systemic embolism (SE)
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Assessment method [10]
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0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [10]
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0
8 months
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Primary outcome [11]
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0
Stroke/Systemic embolism (SE)
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Assessment method [11]
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0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [11]
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12 months
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Primary outcome [12]
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0
Stroke/Systemic embolism (SE)
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Assessment method [12]
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0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [12]
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0
16 months
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Primary outcome [13]
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0
Stroke/Systemic embolism (SE)
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Assessment method [13]
0
0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [13]
0
0
20 months
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Primary outcome [14]
0
0
Stroke/Systemic embolism (SE)
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Assessment method [14]
0
0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [14]
0
0
24 months
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Primary outcome [15]
0
0
Stroke/Systemic embolism (SE)
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Assessment method [15]
0
0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [15]
0
0
3 years
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Primary outcome [16]
0
0
Stroke/Systemic embolism (SE)
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Assessment method [16]
0
0
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
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Timepoint [16]
0
0
4 years
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Primary outcome [17]
0
0
Major bleeding
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Assessment method [17]
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0
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.
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Timepoint [17]
0
0
4 months
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Primary outcome [18]
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0
Major bleeding
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Assessment method [18]
0
0
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.
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Timepoint [18]
0
0
8 months
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Primary outcome [19]
0
0
Major bleeding
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Assessment method [19]
0
0
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.
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Timepoint [19]
0
0
12 months
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Primary outcome [20]
0
0
Major bleeding
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Assessment method [20]
0
0
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.
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Timepoint [20]
0
0
16 months
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Primary outcome [21]
0
0
Major bleeding
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Assessment method [21]
0
0
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.
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Timepoint [21]
0
0
20 months
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Primary outcome [22]
0
0
Major bleeding
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Assessment method [22]
0
0
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.
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Timepoint [22]
0
0
24 months
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Primary outcome [23]
0
0
Major bleeding
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Assessment method [23]
0
0
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.
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Timepoint [23]
0
0
3 years
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Primary outcome [24]
0
0
Major bleeding
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Assessment method [24]
0
0
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.
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Timepoint [24]
0
0
4 years
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Secondary outcome [1]
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0
Cerebrovascular events defined as Stroke
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Assessment method [1]
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0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [1]
0
0
4 months
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Secondary outcome [2]
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0
Cerebrovascular events defined as Stroke
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Assessment method [2]
0
0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [2]
0
0
8 months
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Secondary outcome [3]
0
0
Cerebrovascular events defined as Stroke
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Assessment method [3]
0
0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [3]
0
0
12 months
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Secondary outcome [4]
0
0
Cerebrovascular events defined as Stroke
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Assessment method [4]
0
0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [4]
0
0
16 months
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Secondary outcome [5]
0
0
Cerebrovascular events defined as Stroke
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Assessment method [5]
0
0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [5]
0
0
20 months
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Secondary outcome [6]
0
0
Cerebrovascular events defined as Stroke
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Assessment method [6]
0
0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [6]
0
0
24 months
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Secondary outcome [7]
0
0
Cerebrovascular events defined as Stroke
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Assessment method [7]
0
0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [7]
0
0
3 years
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Secondary outcome [8]
0
0
Cerebrovascular events defined as Stroke
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Assessment method [8]
0
0
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
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Timepoint [8]
0
0
4 years
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Secondary outcome [9]
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0
Transient Ischemic Attacks (TIA)
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Assessment method [9]
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0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [9]
0
0
4 months
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Secondary outcome [10]
0
0
Transient Ischemic Attacks (TIA)
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Assessment method [10]
0
0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [10]
0
0
8 months
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Secondary outcome [11]
0
0
Transient Ischemic Attacks (TIA)
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Assessment method [11]
0
0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [11]
0
0
12 months
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Secondary outcome [12]
0
0
Transient Ischemic Attacks (TIA)
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Assessment method [12]
0
0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [12]
0
0
16 months
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Secondary outcome [13]
0
0
Transient Ischemic Attacks (TIA)
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Assessment method [13]
0
0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [13]
0
0
20 months
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Secondary outcome [14]
0
0
Transient Ischemic Attacks (TIA)
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Assessment method [14]
0
0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [14]
0
0
24 months
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Secondary outcome [15]
0
0
Transient Ischemic Attacks (TIA)
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Assessment method [15]
0
0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [15]
0
0
3 years
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Secondary outcome [16]
0
0
Transient Ischemic Attacks (TIA)
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Assessment method [16]
0
0
Number of Transient Ischemic Attacks (TIA)
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Timepoint [16]
0
0
4 years
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Secondary outcome [17]
0
0
Acute coronary syndromes
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Assessment method [17]
0
0
Number including unstable angina, STEMI, Non-STEMI
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Timepoint [17]
0
0
4 months
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Secondary outcome [18]
0
0
Acute coronary syndromes
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Assessment method [18]
0
0
Number including unstable angina, STEMI, Non-STEMI
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Timepoint [18]
0
0
8 months
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Secondary outcome [19]
0
0
Acute coronary syndromes
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Assessment method [19]
0
0
Number Including unstable angina, STEMI, Non-STEMI
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Timepoint [19]
0
0
12 months
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Secondary outcome [20]
0
0
Acute coronary syndromes
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Assessment method [20]
0
0
Number including unstable angina, STEMI, Non-STEMI
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Timepoint [20]
0
0
16 months
Query!
Secondary outcome [21]
0
0
Acute coronary syndromes
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Assessment method [21]
0
0
Number including unstable angina, STEMI, Non-STEMI
Query!
Timepoint [21]
0
0
20 months
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Secondary outcome [22]
0
0
Acute coronary syndromes
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Assessment method [22]
0
0
Number including Unstable angina, STEMI, Non-STEMI
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Timepoint [22]
0
0
24 months
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Secondary outcome [23]
0
0
Acute coronary syndromes
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Assessment method [23]
0
0
Number including unstable angina, STEMI, Non-STEMI
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Timepoint [23]
0
0
3 years
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Secondary outcome [24]
0
0
Acute coronary syndromes
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Assessment method [24]
0
0
Number including unstable angina, STEMI, Non-STEMI
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Timepoint [24]
0
0
4 years
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Secondary outcome [25]
0
0
Therapy persistence
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Assessment method [25]
0
0
Participant duration of time on therapy
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Timepoint [25]
0
0
4 months
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Secondary outcome [26]
0
0
Therapy persistence
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Assessment method [26]
0
0
Participant duration of time on therapy
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Timepoint [26]
0
0
8 months
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Secondary outcome [27]
0
0
Therapy persistence
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Assessment method [27]
0
0
Participant duration of time on therapy
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Timepoint [27]
0
0
12 months
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Secondary outcome [28]
0
0
Therapy persistence
Query!
Assessment method [28]
0
0
Participant duration of time on therapy
Query!
Timepoint [28]
0
0
16 months
Query!
Secondary outcome [29]
0
0
Therapy persistence
Query!
Assessment method [29]
0
0
Participant duration of time on therapy
Query!
Timepoint [29]
0
0
20 months
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Secondary outcome [30]
0
0
Therapy persistence
Query!
Assessment method [30]
0
0
Participant duration of time on therapy
Query!
Timepoint [30]
0
0
24 months
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Secondary outcome [31]
0
0
Therapy persistence
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Assessment method [31]
0
0
Participant rate of discontinuation
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Timepoint [31]
0
0
3 years
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Secondary outcome [32]
0
0
Therapy persistence
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Assessment method [32]
0
0
Participant duration of time on therapy
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Timepoint [32]
0
0
4 years
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Secondary outcome [33]
0
0
Incidences of other clinical events
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Assessment method [33]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [33]
0
0
4 months
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Secondary outcome [34]
0
0
Incidences of other clinical events
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Assessment method [34]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [34]
0
0
8 months
Query!
Secondary outcome [35]
0
0
Incidences of other clinical events
Query!
Assessment method [35]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [35]
0
0
12 months
Query!
Secondary outcome [36]
0
0
Incidences of other clinical events
Query!
Assessment method [36]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [36]
0
0
16 months
Query!
Secondary outcome [37]
0
0
Incidences of other clinical events
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Assessment method [37]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [37]
0
0
20 months
Query!
Secondary outcome [38]
0
0
Incidences of other clinical events
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Assessment method [38]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [38]
0
0
24 months
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Secondary outcome [39]
0
0
Incidences of other clinical events
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Assessment method [39]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [39]
0
0
3 years
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Secondary outcome [40]
0
0
Incidences of other clinical events
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Assessment method [40]
0
0
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
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Timepoint [40]
0
0
4 years
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Secondary outcome [41]
0
0
Bleeding Events
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Assessment method [41]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
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Timepoint [41]
0
0
4 months
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Secondary outcome [42]
0
0
Bleeding Events
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Assessment method [42]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Query!
Timepoint [42]
0
0
8 months
Query!
Secondary outcome [43]
0
0
Bleeding Events
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Assessment method [43]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Query!
Timepoint [43]
0
0
12 months
Query!
Secondary outcome [44]
0
0
Bleeding Events
Query!
Assessment method [44]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Query!
Timepoint [44]
0
0
16 months
Query!
Secondary outcome [45]
0
0
Bleeding Events
Query!
Assessment method [45]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Query!
Timepoint [45]
0
0
20 months
Query!
Secondary outcome [46]
0
0
Bleeding Events
Query!
Assessment method [46]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Query!
Timepoint [46]
0
0
24 months
Query!
Secondary outcome [47]
0
0
Bleeding Events
Query!
Assessment method [47]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Query!
Timepoint [47]
0
0
3 years
Query!
Secondary outcome [48]
0
0
Bleeding Events
Query!
Assessment method [48]
0
0
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Query!
Timepoint [48]
0
0
4 years
Query!
Secondary outcome [49]
0
0
Pulmonary Embolism
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Assessment method [49]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [49]
0
0
4 months
Query!
Secondary outcome [50]
0
0
Pulmonary Embolism
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Assessment method [50]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [50]
0
0
8 months
Query!
Secondary outcome [51]
0
0
Pulmonary Embolism
Query!
Assessment method [51]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [51]
0
0
12 months
Query!
Secondary outcome [52]
0
0
Pulmonary Embolism
Query!
Assessment method [52]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [52]
0
0
16 months
Query!
Secondary outcome [53]
0
0
Pulmonary Embolism
Query!
Assessment method [53]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [53]
0
0
20 months
Query!
Secondary outcome [54]
0
0
Pulmonary Embolism
Query!
Assessment method [54]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [54]
0
0
24 months
Query!
Secondary outcome [55]
0
0
Pulmonary Embolism
Query!
Assessment method [55]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [55]
0
0
3 years
Query!
Secondary outcome [56]
0
0
Pulmonary Embolism
Query!
Assessment method [56]
0
0
Number of participants with a Pulmonary Embolism
Query!
Timepoint [56]
0
0
4 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/05/2020
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Sample size
Target
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Accrual to date
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Final
57250
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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0
- Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Massachusetts
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Tucumán
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Country [3]
0
0
Austria
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State/province [3]
0
0
Graz
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Country [4]
0
0
Belgium
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State/province [4]
0
0
Brasschaat
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Country [5]
0
0
Brazil
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State/province [5]
0
0
São Paulo
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Country [6]
0
0
Canada
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State/province [6]
0
0
Hamilton
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Country [7]
0
0
Chile
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State/province [7]
0
0
Santiago
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Country [8]
0
0
China
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State/province [8]
0
0
Beijing
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Country [9]
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Coventry
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Funding & Sponsors
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Other
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Thrombosis Research Institute
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Bayer
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University of Birmingham
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Other
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Brigham and Women's Hospital
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Quintiles, Inc.
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Other
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Advanced Drug and Device Services SAS
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Apothecaries Clinical Research
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01090362
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Trial related presentations / publications
Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012 Jan;163(1):13-19.e1. doi: 10.1016/j.ahj.2011.09.011. Epub 2011 Nov 20.
Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA; UK GARFIELD Investigators and GARFIELD Steering Committee. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc Disord. 2013 Apr 23;13:31. doi: 10.1186/1471-2261-13-31.
Aalbers J. GARFIELD: a window on the real-life treatment of atrial fibrillation - South Africa joins the GARFIELD registry. Cardiovasc J Afr. 2012 Oct;23(9):528. No abstract available.
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Public notes
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Contacts
Principal investigator
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Ajay K Kakkar
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Thrombosis Research Institute, London, UK
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01090362
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