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Global Anticoagulant Registry in the Field (GARFIELD-AF)

T

Thrombosis Research Institute

Status

Completed

Conditions

Atrial Fibrillation

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01090362
TRI08888

Details and patient eligibility

About

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).

Full 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.

Enrollment

57,250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

57,250 participants in 5 patient groups

Cohort 1
Description:
Cohort complete with 5,088 retrospective patients and 5,499 prospective patients recruited from 19 countries.
Cohort 2
Description:
Cohort completed with 11,351 patients enrolled from 30 countries
Cohort 3
Description:
Cohort 3 completed with 11,139 patients enrolled globally from 32 countries
Cohort 4
Description:
Cohort 4 completed with 11,2780 patients enrolled from 35 countries.
Cohort 5
Description:
Final cohort completed with 12,186 patients enrolled.

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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