Have you or your loved ones been diagnosed with atrial fibrillation?
You may be eligible to participate in a atrial fibrillation clinical trial.
Have you or your loved ones been diagnosed with atrial fibrillation? You may be eligible to participate in a atrial fibrillation clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Atrial Fibrillation Clinical Trial in Tampere
Have you or your loved ones been diagnosed with atrial fibrillation?
You may be eligible to participate in a atrial fibrillation clinical trial.
Have you or your loved ones been diagnosed with atrial fibrillation? You may be eligible to participate in a atrial fibrillation clinical trial.
Completed
Male & Female
18 Years +
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).
Details for the 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.
Brief Title
Global Anticoagulant Registry in the Field
Official Title
Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
Brief Summary
The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is <br /> a non-interventional, observational study that characterized a global population of <br /> non-valvular atrial fibrillation patients. The registry was used to document global baseline <br /> characteristics, current treatment strategies and outcome measures. Characterisation of a <br /> number of AF sub-populations was also completed. GARFIELD-AF is an independent academic <br /> research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported <br /> 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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
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.
Primary
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.
Primary
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.
Primary
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.
Primary
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.
Primary
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.
Primary
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.
Primary
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.
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Death
All cause mortality including cardiovascular and non-cardiovascular death
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Primary
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Secondary
Therapy persistence
Participant duration of time on therapy
Secondary
Therapy persistence
Participant rate of discontinuation
Secondary
Therapy persistence
Participant duration of time on therapy
Secondary
Therapy persistence
Participant duration of time on therapy
Secondary
Therapy persistence
Participant duration of time on therapy
Secondary
Therapy persistence
Participant duration of time on therapy
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Therapy persistence
Participant duration of time on therapy
Secondary
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Secondary
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Secondary
Acute coronary syndromes
Number including Unstable angina, STEMI, Non-STEMI
Secondary
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Secondary
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Secondary
Acute coronary syndromes
Number Including unstable angina, STEMI, Non-STEMI
Secondary
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Secondary
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Secondary
Therapy persistence
Participant duration of time on therapy
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Secondary
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Secondary
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Study 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.