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Global Anticoagulant Registry in the Field (GARFIELD-AF)

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ClinicalTrials.gov Identifier: NCT01090362
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
Bayer
University of Birmingham
Brigham and Women's Hospital
Quintiles, Inc.
Advanced Drug and Device Services SAS
Apothecaries Clinical Research
Information provided by (Responsible Party):
Thrombosis Research Institute

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).

Condition or disease
Atrial Fibrillation

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.

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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

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Death [ Time Frame: 4 months ]
    All cause mortality including cardiovascular and non-cardiovascular death

  2. Death [ Time Frame: 8 months ]
    All cause mortality including cardiovascular and non-cardiovascular death

  3. Death [ Time Frame: 12 months ]
    All cause mortality including cardiovascular and non-cardiovascular death

  4. Death [ Time Frame: 16 months ]
    All cause mortality including cardiovascular and non-cardiovascular death

  5. Death [ Time Frame: 20 months ]
    All cause mortality including cardiovascular and non-cardiovascular death

  6. Death [ Time Frame: 24 months ]
    All cause mortality including cardiovascular and non-cardiovascular death

  7. Death [ Time Frame: 3 years ]
    All cause mortality including cardiovascular and non-cardiovascular death

  8. Death [ Time Frame: 4 years ]
    All cause mortality including cardiovascular and non-cardiovascular death

  9. Stroke/Systemic embolism (SE) [ Time Frame: 4 months ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  10. Stroke/Systemic embolism (SE) [ Time Frame: 8 months ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  11. Stroke/Systemic embolism (SE) [ Time Frame: 12 months ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  12. Stroke/Systemic embolism (SE) [ Time Frame: 16 months ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  13. Stroke/Systemic embolism (SE) [ Time Frame: 20 months ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  14. Stroke/Systemic embolism (SE) [ Time Frame: 24 months ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  15. Stroke/Systemic embolism (SE) [ Time Frame: 3 years ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  16. Stroke/Systemic embolism (SE) [ Time Frame: 4 years ]
    Stroke/SE was defined as the combined end points of ischemic stroke, and SE

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.


Secondary Outcome Measures :
  1. Cerebrovascular events defined as Stroke [ Time Frame: 4 months ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  2. Cerebrovascular events defined as Stroke [ Time Frame: 8 months ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  3. Cerebrovascular events defined as Stroke [ Time Frame: 12 months ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  4. Cerebrovascular events defined as Stroke [ Time Frame: 16 months ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  5. Cerebrovascular events defined as Stroke [ Time Frame: 20 months ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  6. Cerebrovascular events defined as Stroke [ Time Frame: 24 months ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  7. Cerebrovascular events defined as Stroke [ Time Frame: 3 years ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  8. Cerebrovascular events defined as Stroke [ Time Frame: 4 years ]
    Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.

  9. Transient Ischemic Attacks (TIA) [ Time Frame: 4 months ]
    Number of Transient Ischemic Attacks (TIA)

  10. Transient Ischemic Attacks (TIA) [ Time Frame: 8 months ]
    Number of Transient Ischemic Attacks (TIA)

  11. Transient Ischemic Attacks (TIA) [ Time Frame: 12 months ]
    Number of Transient Ischemic Attacks (TIA)

  12. Transient Ischemic Attacks (TIA) [ Time Frame: 16 months ]
    Number of Transient Ischemic Attacks (TIA)

  13. Transient Ischemic Attacks (TIA) [ Time Frame: 20 months ]
    Number of Transient Ischemic Attacks (TIA)

  14. Transient Ischemic Attacks (TIA) [ Time Frame: 24 months ]
    Number of Transient Ischemic Attacks (TIA)

  15. Transient Ischemic Attacks (TIA) [ Time Frame: 3 years ]
    Number of Transient Ischemic Attacks (TIA)

  16. Transient Ischemic Attacks (TIA) [ Time Frame: 4 years ]
    Number of Transient Ischemic Attacks (TIA)

  17. Acute coronary syndromes [ Time Frame: 4 months ]
    Number including unstable angina, STEMI, Non-STEMI

  18. Acute coronary syndromes [ Time Frame: 8 months ]
    Number including unstable angina, STEMI, Non-STEMI

  19. Acute coronary syndromes [ Time Frame: 12 months ]
    Number Including unstable angina, STEMI, Non-STEMI

  20. Acute coronary syndromes [ Time Frame: 16 months ]
    Number including unstable angina, STEMI, Non-STEMI

  21. Acute coronary syndromes [ Time Frame: 20 months ]
    Number including unstable angina, STEMI, Non-STEMI

  22. Acute coronary syndromes [ Time Frame: 24 months ]
    Number including Unstable angina, STEMI, Non-STEMI

  23. Acute coronary syndromes [ Time Frame: 3 years ]
    Number including unstable angina, STEMI, Non-STEMI

  24. Acute coronary syndromes [ Time Frame: 4 years ]
    Number including unstable angina, STEMI, Non-STEMI

  25. Therapy persistence [ Time Frame: 4 months ]
    Participant duration of time on therapy

  26. Therapy persistence [ Time Frame: 8 months ]
    Participant duration of time on therapy

  27. Therapy persistence [ Time Frame: 12 months ]
    Participant duration of time on therapy

  28. Therapy persistence [ Time Frame: 16 months ]
    Participant duration of time on therapy

  29. Therapy persistence [ Time Frame: 20 months ]
    Participant duration of time on therapy

  30. Therapy persistence [ Time Frame: 24 months ]
    Participant duration of time on therapy

  31. Therapy persistence [ Time Frame: 3 years ]
    Participant rate of discontinuation

  32. Therapy persistence [ Time Frame: 4 years ]
    Participant duration of time on therapy

  33. Incidences of other clinical events [ Time Frame: 4 months ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  34. Incidences of other clinical events [ Time Frame: 8 months ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  35. Incidences of other clinical events [ Time Frame: 12 months ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  36. Incidences of other clinical events [ Time Frame: 16 months ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  37. Incidences of other clinical events [ Time Frame: 20 months ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  38. Incidences of other clinical events [ Time Frame: 24 months ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  39. Incidences of other clinical events [ Time Frame: 3 years ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  40. Incidences of other clinical events [ Time Frame: 4 years ]
    Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)

  41. Bleeding Events [ Time Frame: 4 months ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  42. Bleeding Events [ Time Frame: 8 months ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  43. Bleeding Events [ Time Frame: 12 months ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  44. Bleeding Events [ Time Frame: 16 months ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  45. Bleeding Events [ Time Frame: 20 months ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  46. Bleeding Events [ Time Frame: 24 months ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  47. Bleeding Events [ Time Frame: 3 years ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  48. Bleeding Events [ Time Frame: 4 years ]
    Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event

  49. Pulmonary Embolism [ Time Frame: 4 months ]
    Number of participants with a Pulmonary Embolism

  50. Pulmonary Embolism [ Time Frame: 8 months ]
    Number of participants with a Pulmonary Embolism

  51. Pulmonary Embolism [ Time Frame: 12 months ]
    Number of participants with a Pulmonary Embolism

  52. Pulmonary Embolism [ Time Frame: 16 months ]
    Number of participants with a Pulmonary Embolism

  53. Pulmonary Embolism [ Time Frame: 20 months ]
    Number of participants with a Pulmonary Embolism

  54. Pulmonary Embolism [ Time Frame: 24 months ]
    Number of participants with a Pulmonary Embolism

  55. Pulmonary Embolism [ Time Frame: 3 years ]
    Number of participants with a Pulmonary Embolism

  56. Pulmonary Embolism [ Time Frame: 4 years ]
    Number of participants with a Pulmonary Embolism



Information from the National Library of Medicine

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.


Layout table for eligibility information
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
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.
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.

Information from the National Library of Medicine

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


Locations
Show Show 35 study locations
Sponsors and Collaborators
Thrombosis Research Institute
Bayer
University of Birmingham
Brigham and Women's Hospital
Quintiles, Inc.
Advanced Drug and Device Services SAS
Apothecaries Clinical Research
Investigators
Layout table for investigator information
Study Director: Ajay K Kakkar Thrombosis Research Institute, London, UK
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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
Keywords provided by Thrombosis Research Institute:
Atrial fibrillation
Anticoagulation
Stroke
Stroke prevention
Health Economics
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes