Global Anticoagulant Registry in the Field (GARFIELD-AF)

April 26, 2021 updated by: Thrombosis Research Institute

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

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

57250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tucumán, Argentina
        • Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman
      • Melbourne, Australia
        • Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital
      • Graz, Austria
        • Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz
      • Brasschaat, Belgium
        • Dr Frank Cools, National Co-ordinating Investigator, AZ Klina
      • São Paulo, Brazil
        • Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,
      • Hamilton, Canada
        • Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University
      • Santiago, Chile
        • Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile
      • Beijing, China
        • Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital
      • Prague, Czechia
        • Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital
      • Frederiksberg, Denmark
        • Prof Joern Dalsgaard Nielsen, National Coordinating Investigator, Bispebjerg & Frederiksberg Hospitals
      • Cairo, Egypt
        • Dr. Hany Ragy, National Coordinating Investigator, Hayat Hospital
      • Tampere, Finland
        • Prof Pekka Raatikainen, National Coordinating Investigator, Univesrsity of Tampere
      • Paris, France
        • Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou
      • Berlin, Germany
        • Prof Harald Darius, National oordinating Investigator, Vivantes Klinikum Neukölln
      • Budapest, Hungary
        • Dr Matyas Keltai, National Coordinating Investigator, Hungarian Institute of Cardiology
      • Bangalore, India
        • Dr Sawney, National Coordinating Investigator, Sir Ganga Ram Hospital, New Delhi
      • Perugia, Italy
        • Profs Giancarlo Agnelli and Giuseppe Ambrosio, National Coordinating Investigators, University of Perugia
      • Osaka, Japan
        • Professor Yukihiro Koretsune, National Coordinating Investigator, Osaka National Hospital
      • Seoul, Korea, Republic of
        • Prof. Seil Oh, National Coordinating Investigator, National University Hospital
      • Monterrey, Mexico
        • Dr Carlos Jerjes Sanchez Diaz, National Coordinating Investigator,Tecnologico de Monterrey
      • Maastricht, Netherlands
        • Professor Hugo ten Cate, National Coordinating Investigator, Cardiovascular Research Institute Maastricht
      • Oslo, Norway
        • Professor Dan Atar, National Coordinating Investigator, Oslo University Hospital
      • Warsaw, Poland
        • Prof Janina Stępińska, National Coordinating Investigator, Institute of Cardiology, Warsaw
      • Moscow, Russian Federation
        • Professor Elizaveta Panchenko, National Coordinating Investigator, Cardiology Research and Production Center
      • Singapore, Singapore
        • Dr Toon Wei Lim, National Coordinating Investigator, National University Hospital
      • Johannesburg, South Africa
        • Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand
      • Barcelona, Spain
        • Dr Xavier Vinolas, National Coordinating Investigator, Hospital Santa Creu y San Pau
      • Stockholm, Sweden
        • Dr Marten Rosenqvist, National Coordinating Investigator, Karolinska Institute
      • Zurich, Switzerland
        • Dr Jan Steffel, National Coordinating Investigator, University Hospital
      • Bangkok, Thailand
        • Prof. Pantep Angchaisuksiri, National Coordinating Investigator, Ramathibodi Hospital, Mahidol University
      • Ankara, Turkey
        • Professor Ali Oto, National Coordinating Investigator, Memorial Ankara Hospital
      • Kiev, Ukraine
        • Prof. Alexandr Parkhomenko, National Coordinating Investigator, Strazhesko Institute of Cardiology
      • Abu Dhabi, United Arab Emirates
        • Prof. Wael Al Mahmeed, National Coordinating Investigator, SKMC Cardiac Siences
      • Coventry, United Kingdom
        • Prof. David Fitzmaurice, National Coordinating Investigator, University of Warwick
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Prof. Samuel Goldhaber

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12 months
All cause mortality including cardiovascular and non-cardiovascular death
12 months
Death
Time Frame: 24 months
All cause mortality including cardiovascular and non-cardiovascular death
24 months
Death
Time Frame: 3 years
All cause mortality including cardiovascular and non-cardiovascular death
3 years
Death
Time Frame: 4 years
All cause mortality including cardiovascular and non-cardiovascular death
4 years
Death
Time Frame: 4 months
All cause mortality including cardiovascular and non-cardiovascular death
4 months
Death
Time Frame: 8 months
All cause mortality including cardiovascular and non-cardiovascular death
8 months
Death
Time Frame: 16 months
All cause mortality including cardiovascular and non-cardiovascular death
16 months
Death
Time Frame: 20 months
All cause mortality including cardiovascular and non-cardiovascular death
20 months
Stroke/Systemic embolism (SE)
Time Frame: 4 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
4 months
Stroke/Systemic embolism (SE)
Time Frame: 8 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
8 months
Stroke/Systemic embolism (SE)
Time Frame: 12 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
12 months
Stroke/Systemic embolism (SE)
Time Frame: 16 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
16 months
Stroke/Systemic embolism (SE)
Time Frame: 20 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
20 months
Stroke/Systemic embolism (SE)
Time Frame: 24 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
24 months
Stroke/Systemic embolism (SE)
Time Frame: 3 years
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
3 years
Stroke/Systemic embolism (SE)
Time Frame: 4 years
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
4 years
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.
4 months
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.
8 months
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.
12 months
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.
16 months
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.
20 months
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.
24 months
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.
3 years
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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebrovascular events defined as Stroke
Time Frame: 4 months
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
4 months
Cerebrovascular events defined as Stroke
Time Frame: 8 months
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
8 months
Cerebrovascular events defined as Stroke
Time Frame: 12 months
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
12 months
Cerebrovascular events defined as Stroke
Time Frame: 16 months
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
16 months
Cerebrovascular events defined as Stroke
Time Frame: 20 months
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
20 months
Cerebrovascular events defined as Stroke
Time Frame: 24 months
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
24 months
Cerebrovascular events defined as Stroke
Time Frame: 3 years
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
3 years
Cerebrovascular events defined as Stroke
Time Frame: 4 years
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
4 years
Transient Ischemic Attacks (TIA)
Time Frame: 4 months
Number of Transient Ischemic Attacks (TIA)
4 months
Transient Ischemic Attacks (TIA)
Time Frame: 8 months
Number of Transient Ischemic Attacks (TIA)
8 months
Transient Ischemic Attacks (TIA)
Time Frame: 12 months
Number of Transient Ischemic Attacks (TIA)
12 months
Transient Ischemic Attacks (TIA)
Time Frame: 16 months
Number of Transient Ischemic Attacks (TIA)
16 months
Transient Ischemic Attacks (TIA)
Time Frame: 20 months
Number of Transient Ischemic Attacks (TIA)
20 months
Transient Ischemic Attacks (TIA)
Time Frame: 24 months
Number of Transient Ischemic Attacks (TIA)
24 months
Transient Ischemic Attacks (TIA)
Time Frame: 3 years
Number of Transient Ischemic Attacks (TIA)
3 years
Transient Ischemic Attacks (TIA)
Time Frame: 4 years
Number of Transient Ischemic Attacks (TIA)
4 years
Acute coronary syndromes
Time Frame: 4 months
Number including unstable angina, STEMI, Non-STEMI
4 months
Acute coronary syndromes
Time Frame: 8 months
Number including unstable angina, STEMI, Non-STEMI
8 months
Acute coronary syndromes
Time Frame: 12 months
Number Including unstable angina, STEMI, Non-STEMI
12 months
Acute coronary syndromes
Time Frame: 16 months
Number including unstable angina, STEMI, Non-STEMI
16 months
Acute coronary syndromes
Time Frame: 20 months
Number including unstable angina, STEMI, Non-STEMI
20 months
Acute coronary syndromes
Time Frame: 24 months
Number including Unstable angina, STEMI, Non-STEMI
24 months
Acute coronary syndromes
Time Frame: 3 years
Number including unstable angina, STEMI, Non-STEMI
3 years
Acute coronary syndromes
Time Frame: 4 years
Number including unstable angina, STEMI, Non-STEMI
4 years
Therapy persistence
Time Frame: 4 months
Participant duration of time on therapy
4 months
Therapy persistence
Time Frame: 8 months
Participant duration of time on therapy
8 months
Therapy persistence
Time Frame: 12 months
Participant duration of time on therapy
12 months
Therapy persistence
Time Frame: 16 months
Participant duration of time on therapy
16 months
Therapy persistence
Time Frame: 20 months
Participant duration of time on therapy
20 months
Therapy persistence
Time Frame: 24 months
Participant duration of time on therapy
24 months
Therapy persistence
Time Frame: 3 years
Participant rate of discontinuation
3 years
Therapy persistence
Time Frame: 4 years
Participant duration of time on therapy
4 years
Incidences of other clinical events
Time Frame: 4 months
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
4 months
Incidences of other clinical events
Time Frame: 8 months
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
8 months
Incidences of other clinical events
Time Frame: 12 months
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
12 months
Incidences of other clinical events
Time Frame: 16 months
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
16 months
Incidences of other clinical events
Time Frame: 20 months
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
20 months
Incidences of other clinical events
Time Frame: 24 months
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
24 months
Incidences of other clinical events
Time Frame: 3 years
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
3 years
Incidences of other clinical events
Time Frame: 4 years
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
4 years
Bleeding Events
Time Frame: 4 months
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
4 months
Bleeding Events
Time Frame: 8 months
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
8 months
Bleeding Events
Time Frame: 12 months
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
12 months
Bleeding Events
Time Frame: 16 months
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
16 months
Bleeding Events
Time Frame: 20 months
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
20 months
Bleeding Events
Time Frame: 24 months
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
24 months
Bleeding Events
Time Frame: 3 years
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
3 years
Bleeding Events
Time Frame: 4 years
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
4 years
Pulmonary Embolism
Time Frame: 4 months
Number of participants with a Pulmonary Embolism
4 months
Pulmonary Embolism
Time Frame: 8 months
Number of participants with a Pulmonary Embolism
8 months
Pulmonary Embolism
Time Frame: 12 months
Number of participants with a Pulmonary Embolism
12 months
Pulmonary Embolism
Time Frame: 16 months
Number of participants with a Pulmonary Embolism
16 months
Pulmonary Embolism
Time Frame: 20 months
Number of participants with a Pulmonary Embolism
20 months
Pulmonary Embolism
Time Frame: 24 months
Number of participants with a Pulmonary Embolism
24 months
Pulmonary Embolism
Time Frame: 3 years
Number of participants with a Pulmonary Embolism
3 years
Pulmonary Embolism
Time Frame: 4 years
Number of participants with a Pulmonary Embolism
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ajay K Kakkar, Thrombosis Research Institute, London, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2009

Primary Completion (ACTUAL)

June 16, 2019

Study Completion (ACTUAL)

May 18, 2020

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (ESTIMATE)

March 19, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Subscribe