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Completed

NCT Number: NCT01090362

Global Anticoagulant Registry in the Field

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman, San Miguel de Tucumán, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Thrombosis Research Institute

Other

Collaborators

  • Advanced Drug and Device Services SAS
  • Apothecaries Clinical Research
  • Bayer
  • Brigham and Women's Hospital
  • Quintiles, Inc.
  • University of Birmingham

Registry information

Official study title

Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.

Acronym: GARFIELD-AF

Important dates

Study start
2009
Primary completion
2019
Study completion
2020
First posted
Mar 19, 2010
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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