Global Anticoagulant Registry in the Field (GARFIELD-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Thrombosis Research Institute
Sponsor:
Collaborators:
Bayer
University of Birmingham
Brigham and Women's Hospital
Quintiles
Advanced Drug and Device Services SAS
Apothecaries Clinical Research
Information provided by (Responsible Party):
Thrombosis Research Institute
ClinicalTrials.gov Identifier:
NCT01090362
First received: March 18, 2010
Last updated: December 4, 2014
Last verified: December 2014

March 18, 2010
December 4, 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 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 4 and 6 years ] [ Designated as safety issue: No ]
  • Thromboembolic stroke [ Time Frame: 4 and 6 years ] [ Designated as safety issue: Yes ]
  • Transient ischaemic attack [ Time Frame: 4 years and 6years ] [ Designated as safety issue: Yes ]
  • Systemic embolisation [ Time Frame: 4 and 6 years ] [ Designated as safety issue: Yes ]
    Frequency of bleeding events (classified as major, clinically relevant non-major and minor)
  • Therapy persistence [ Time Frame: 4 and 6 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Analysis of major bleeding events with regard to hospitalisation and outcomes [ Time Frame: 4 and 6 years ] [ Designated as safety issue: No ]
  • Any healthcare resource use (GP, hospital or clinic visits) as a result of anticoagulation [ Time Frame: 4 and 6 years ] [ Designated as safety issue: No ]
  • MAJOR ADVERSE CARDIAC EVENTS (MACE) [ Time Frame: 4 and 6 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    For patients treated with VKA additionally:
  • INR recordings in relation to therapeutic range [ Time Frame: 4 and 6 years ] [ Designated as safety issue: No ]
    For patients treated with VKA additionally
  • Use of bridging anticoagulation necessitated by vitamin-K antagonist interruption [ Time Frame: 4 and 6 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Heart failure [ Time Frame: 4 monthly for 24 mths then annually until 2018 ] [ Designated as safety issue: No ]
  • Acute coronary syndromes [ Time Frame: 4 monthly for 24 mths then annually until 2018 ] [ Designated as safety issue: No ]
  • Therapy persistence [ Time Frame: 4 monthly for 24 mths then annually until 2018 ] [ Designated as safety issue: No ]
  • Patient satisfaction with oral anticoagulant treatment [ Time Frame: 4, 8, 12 and 24 months ] [ Designated as safety issue: No ]
  • Bleeding Events [ Time Frame: 4 monthly for 24 mths then annually until 2018 ] [ Designated as safety issue: No ]
  • Strokes (Haemorrhagic and thrombotic) [ Time Frame: 4 monthly for 24 mths then annually until 2018 ] [ Designated as safety issue: No ]
  • Peripheral / non-CNS embolism [ Time Frame: 4 and 6 years ] [ Designated as safety issue: Yes ]
  • Heart failure [ Time Frame: 4 and 6 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 4 and 6 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.
 
Recruiting
55000
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.
Both
18 Years and older
No
Contact: Gloria Kayani 00442073518390 gkayani@tri-london.ac.uk
Contact: Oscar Howie 00442073518316 ohowie@tri-london.ac.uk
United States,   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
 
NCT01090362
TRI08888
Yes
Thrombosis Research Institute
Thrombosis Research Institute
  • Bayer
  • University of Birmingham
  • Brigham and Women's Hospital
  • Quintiles
  • 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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP