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
  Purpose

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.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Thrombosis Research Institute:

Primary Outcome Measures:
  • Death [ Time Frame: 4 monthly for 24 mths then annually until 2018 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55000
Study Start Date: December 2009
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090362

Contacts
Contact: Gloria Kayani 00442073518390 gkayani@tri-london.ac.uk
Contact: Oscar Howie 00442073518316 ohowie@tri-london.ac.uk

  Show 35 Study Locations
Sponsors and Collaborators
Thrombosis Research Institute
Bayer
University of Birmingham
Brigham and Women's Hospital
Quintiles
Advanced Drug and Device Services SAS
Apothecaries Clinical Research
Investigators
Study Director: Ajay K Kakkar, MD Thrombosis Research Institute, London, UK
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thrombosis Research Institute
ClinicalTrials.gov Identifier: NCT01090362     History of Changes
Other Study ID Numbers: TRI08888
Study First Received: March 18, 2010
Last Updated: December 4, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Thrombosis Research Institute:
Atrial fibrillation
Anticoagulation
Stroke
Stroke prevention
Health Economics

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2015