Global Anticoagulant Registry in the Field (GARFIELD-AF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01090362 |
Recruitment Status :
Completed
First Posted : March 19, 2010
Last Update Posted : April 28, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Atrial Fibrillation |
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.
Study Type : | Observational |
Actual Enrollment : | 57250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation. |
Actual Study Start Date : | December 21, 2009 |
Actual Primary Completion Date : | June 16, 2019 |
Actual Study Completion Date : | May 18, 2020 |

Group/Cohort |
---|
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.
|
- Death [ Time Frame: 4 months ]All cause mortality including cardiovascular and non-cardiovascular death
- Death [ Time Frame: 8 months ]All cause mortality including cardiovascular and non-cardiovascular death
- Death [ Time Frame: 12 months ]All cause mortality including cardiovascular and non-cardiovascular death
- Death [ Time Frame: 16 months ]All cause mortality including cardiovascular and non-cardiovascular death
- Death [ Time Frame: 20 months ]All cause mortality including cardiovascular and non-cardiovascular death
- Death [ Time Frame: 24 months ]All cause mortality including cardiovascular and non-cardiovascular death
- Death [ Time Frame: 3 years ]All cause mortality including cardiovascular and non-cardiovascular death
- Death [ Time Frame: 4 years ]All cause mortality including cardiovascular and non-cardiovascular death
- Stroke/Systemic embolism (SE) [ Time Frame: 4 months ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Stroke/Systemic embolism (SE) [ Time Frame: 8 months ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Stroke/Systemic embolism (SE) [ Time Frame: 12 months ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Stroke/Systemic embolism (SE) [ Time Frame: 16 months ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Stroke/Systemic embolism (SE) [ Time Frame: 20 months ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Stroke/Systemic embolism (SE) [ Time Frame: 24 months ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Stroke/Systemic embolism (SE) [ Time Frame: 3 years ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Stroke/Systemic embolism (SE) [ Time Frame: 4 years ]Stroke/SE was defined as the combined end points of ischemic stroke, and SE
- Major bleeding [ Time Frame: 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.
- Major bleeding [ Time Frame: 8 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.
- Major bleeding [ Time Frame: 12 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.
- Major bleeding [ Time Frame: 16 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.
- Major bleeding [ Time Frame: 20 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.
- Major bleeding [ Time Frame: 24 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.
- Major bleeding [ Time Frame: 3 years ]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.
- Major bleeding [ Time Frame: 4 years ]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.
- Cerebrovascular events defined as Stroke [ Time Frame: 4 months ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Cerebrovascular events defined as Stroke [ Time Frame: 8 months ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Cerebrovascular events defined as Stroke [ Time Frame: 12 months ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Cerebrovascular events defined as Stroke [ Time Frame: 16 months ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Cerebrovascular events defined as Stroke [ Time Frame: 20 months ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Cerebrovascular events defined as Stroke [ Time Frame: 24 months ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Cerebrovascular events defined as Stroke [ Time Frame: 3 years ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Cerebrovascular events defined as Stroke [ Time Frame: 4 years ]Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
- Transient Ischemic Attacks (TIA) [ Time Frame: 4 months ]Number of Transient Ischemic Attacks (TIA)
- Transient Ischemic Attacks (TIA) [ Time Frame: 8 months ]Number of Transient Ischemic Attacks (TIA)
- Transient Ischemic Attacks (TIA) [ Time Frame: 12 months ]Number of Transient Ischemic Attacks (TIA)
- Transient Ischemic Attacks (TIA) [ Time Frame: 16 months ]Number of Transient Ischemic Attacks (TIA)
- Transient Ischemic Attacks (TIA) [ Time Frame: 20 months ]Number of Transient Ischemic Attacks (TIA)
- Transient Ischemic Attacks (TIA) [ Time Frame: 24 months ]Number of Transient Ischemic Attacks (TIA)
- Transient Ischemic Attacks (TIA) [ Time Frame: 3 years ]Number of Transient Ischemic Attacks (TIA)
- Transient Ischemic Attacks (TIA) [ Time Frame: 4 years ]Number of Transient Ischemic Attacks (TIA)
- Acute coronary syndromes [ Time Frame: 4 months ]Number including unstable angina, STEMI, Non-STEMI
- Acute coronary syndromes [ Time Frame: 8 months ]Number including unstable angina, STEMI, Non-STEMI
- Acute coronary syndromes [ Time Frame: 12 months ]Number Including unstable angina, STEMI, Non-STEMI
- Acute coronary syndromes [ Time Frame: 16 months ]Number including unstable angina, STEMI, Non-STEMI
- Acute coronary syndromes [ Time Frame: 20 months ]Number including unstable angina, STEMI, Non-STEMI
- Acute coronary syndromes [ Time Frame: 24 months ]Number including Unstable angina, STEMI, Non-STEMI
- Acute coronary syndromes [ Time Frame: 3 years ]Number including unstable angina, STEMI, Non-STEMI
- Acute coronary syndromes [ Time Frame: 4 years ]Number including unstable angina, STEMI, Non-STEMI
- Therapy persistence [ Time Frame: 4 months ]Participant duration of time on therapy
- Therapy persistence [ Time Frame: 8 months ]Participant duration of time on therapy
- Therapy persistence [ Time Frame: 12 months ]Participant duration of time on therapy
- Therapy persistence [ Time Frame: 16 months ]Participant duration of time on therapy
- Therapy persistence [ Time Frame: 20 months ]Participant duration of time on therapy
- Therapy persistence [ Time Frame: 24 months ]Participant duration of time on therapy
- Therapy persistence [ Time Frame: 3 years ]Participant rate of discontinuation
- Therapy persistence [ Time Frame: 4 years ]Participant duration of time on therapy
- Incidences of other clinical events [ Time Frame: 4 months ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Incidences of other clinical events [ Time Frame: 8 months ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Incidences of other clinical events [ Time Frame: 12 months ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Incidences of other clinical events [ Time Frame: 16 months ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Incidences of other clinical events [ Time Frame: 20 months ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Incidences of other clinical events [ Time Frame: 24 months ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Incidences of other clinical events [ Time Frame: 3 years ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Incidences of other clinical events [ Time Frame: 4 years ]Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
- Bleeding Events [ Time Frame: 4 months ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Bleeding Events [ Time Frame: 8 months ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Bleeding Events [ Time Frame: 12 months ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Bleeding Events [ Time Frame: 16 months ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Bleeding Events [ Time Frame: 20 months ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Bleeding Events [ Time Frame: 24 months ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Bleeding Events [ Time Frame: 3 years ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Bleeding Events [ Time Frame: 4 years ]Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
- Pulmonary Embolism [ Time Frame: 4 months ]Number of participants with a Pulmonary Embolism
- Pulmonary Embolism [ Time Frame: 8 months ]Number of participants with a Pulmonary Embolism
- Pulmonary Embolism [ Time Frame: 12 months ]Number of participants with a Pulmonary Embolism
- Pulmonary Embolism [ Time Frame: 16 months ]Number of participants with a Pulmonary Embolism
- Pulmonary Embolism [ Time Frame: 20 months ]Number of participants with a Pulmonary Embolism
- Pulmonary Embolism [ Time Frame: 24 months ]Number of participants with a Pulmonary Embolism
- Pulmonary Embolism [ Time Frame: 3 years ]Number of participants with a Pulmonary Embolism
- Pulmonary Embolism [ Time Frame: 4 years ]Number of participants with a Pulmonary Embolism

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090362

Study Director: | Ajay K Kakkar | Thrombosis Research Institute, London, UK |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Thrombosis Research Institute |
ClinicalTrials.gov Identifier: | NCT01090362 |
Other Study ID Numbers: |
TRI08888 |
First Posted: | March 19, 2010 Key Record Dates |
Last Update Posted: | April 28, 2021 |
Last Verified: | April 2021 |
Atrial fibrillation Anticoagulation Stroke Stroke prevention Health Economics |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |