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Global Anticoagulant Registry in the Field (GARFIELD-AF)

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ClinicalTrials.gov Identifier: NCT01090362
Recruitment Status : Recruiting
First Posted : March 19, 2010
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):

March 18, 2010
March 19, 2010
December 5, 2014
December 2009
July 2018   (Final data collection date for primary outcome measure)
Death [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
  • Thromboembolic stroke [ Time Frame: 4 and 6 years ]
  • Transient ischaemic attack [ Time Frame: 4 years and 6years ]
  • Systemic embolisation [ Time Frame: 4 and 6 years ]
    Frequency of bleeding events (classified as major, clinically relevant non-major and minor)
  • Therapy persistence [ Time Frame: 4 and 6 years ]
    Rate of discontinuation, duration of time on therapy, reasons for discontinuation
  • Duration and cause of treatment interruption or suspension [ Time Frame: 4 and 6 years ]
  • Analysis of major bleeding events with regard to hospitalisation and outcomes [ Time Frame: 4 and 6 years ]
  • Any healthcare resource use (GP, hospital or clinic visits) as a result of anticoagulation [ Time Frame: 4 and 6 years ]
  • Mortality [ Time Frame: 4 and 6 years ]
  • MAJOR ADVERSE CARDIAC EVENTS (MACE) [ Time Frame: 4 and 6 years ]
    A MACE is defined as death from any cause, myocardial infarction, CABG or PTCI
  • Frequency and timing of monitoring required in maintaining therapeutic anticoagulation [ Time Frame: 4 and 6 years ]
    For patients treated with VKA additionally:
  • INR recordings in relation to therapeutic range [ Time Frame: 4 and 6 years ]
    For patients treated with VKA additionally
  • Use of bridging anticoagulation necessitated by vitamin-K antagonist interruption [ Time Frame: 4 and 6 years ]
    For patients treated with VKA additionally
Complete list of historical versions of study NCT01090362 on ClinicalTrials.gov Archive Site
  • Systemic embolism [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
  • Heart failure [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
  • Acute coronary syndromes [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
  • Therapy persistence [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
  • Patient satisfaction with oral anticoagulant treatment [ Time Frame: 4, 8, 12 and 24 months ]
  • Bleeding Events [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
  • Strokes (Haemorrhagic and thrombotic) [ Time Frame: 4 monthly for 24 mths then annually until 2018 ]
  • Peripheral / non-CNS embolism [ Time Frame: 4 and 6 years ]
  • Heart failure [ Time Frame: 4 and 6 years ]
  • Myocardial infarction [ Time Frame: 4 and 6 years ]
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Global Anticoagulant Registry in the Field
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 pioneering real-world prospective registry - one of the largest in the field of non-valvular atrial fibrillation (AF). With an eventual enrolment target of 55,000 patients, GARFIELD-AF aims to enhance understanding of stroke prevention in patients with non-valvular AF worldwide and help in defining future treatment strategies that may eventually influence patient outcomes.

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.

With 3 cohorts complete and 36,000 enrolled GARFIELD-AF continues to recruit patients and, in conjunction with other registries and non-interventional studies, will be the source of further informative and useful data in the coming years. The findings will serve to increase our understanding of the management of patients with AF and improve our practice for their benefit.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Male and female patients newly diagnosed with permanent atrial fibrillation (AF) who are with at least one additional risk of stroke from 18 countries globally.
Atrial Fibrillation
Not Provided
  • 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 ongoing (commenced Aug 2014) with 2600 patients recruited to date and a target of 11,000 patients enrolled from 35 countries.
  • Cohort 5
    Final cohort to commence August 2015 with a target of 11,000 patients enrolled. Last patient enrolled to complete 2 years of follow-up.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2018
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Gloria Kayani 00442073518390 gkayani@tri-london.ac.uk
Contact: Oscar Howie 00442073518316 ohowie@tri-london.ac.uk
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Czech Republic,   Denmark,   Egypt,   Finland,   France,   Germany,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Thailand,   Turkey,   Ukraine,   United Arab Emirates,   United Kingdom,   United States
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Thrombosis Research Institute
Thrombosis Research Institute
  • Bayer
  • University of Birmingham
  • Brigham and Women's Hospital
  • Quintiles, Inc.
  • Advanced Drug and Device Services SAS
  • Apothecaries Clinical Research
Study Director: Ajay K Kakkar, MD Thrombosis Research Institute, London, UK
Thrombosis Research Institute
December 2014