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Global Anticoagulant Registry in the Field (GARFIELD)

This study is currently recruiting participants.
Verified April 2013 by Thrombosis Research Institute
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Thrombosis Research Institute
ClinicalTrials.gov Identifier:
NCT01090362
First received: March 18, 2010
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

This protocol is a large global registry to determine the behaviour of patients with permanent atrial fibrillation (AF) in real-life practice. This will include newly diagnosed patients with permanent AF irrespective of whether or not they receive antiplatelet (anticoagulant or antithrombotic) therapy. In this regard the GARFIELD registry will be unique because it will consider treatment failure in both those who have commenced anticoagulant (Anticlotting) therapy or other pharmacological treatment to prevent stroke, and those who should have commenced anticoagulant therapy to prevent thromboembolic stroke in permanent AF.


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:

U.S. FDA Resources

Further study details as provided by Thrombosis Research Institute:

Primary Outcome Measures:
  • 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 ]
  • Mortality [ 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55000
Study Start Date: December 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Validation Cohort
  1. Validation Cohort will be added to the first cohort to register patients in select countries. 5000 patients with permanent AF enrolled will be enrolled.
  2. The patients registered will be diagnosed with permanent atrial fibrillation, regardless of therapy, with a diagnosis history longer than six months prior to enrolment
  3. Data for patients in the validation cohort will be collected retrospectively from the time of diagnosis to entry in the registry, and prospectively for up to 2 years .
Prospective Cohort

It is to identify sufficient number of sites globally in hospital, community or anticoagulation clinic settings throughout the world for representation in major countries with focus on the GP setting. 50,000 patients of newly diagnosed permanent AF with at least one additional risk factor for stroke will be enrolled to collect a representative sample. Patients will be enrolled as 5 independent cohorts of 10,000 patients each. Additional validation cohort of 5,000 patients with established permanent Atrial Fibrillation with at least one additional risk factor for stroke regardless of therapy and having been managed at sites for longer than 6 months will also be included in addition to the first prospective cohort of 10,000 patients.

For the validation cohort there will be in addition to the prospective follow-up, a retrospective data-collection for minimum of six months up to 2 years.

  Show Detailed Description

  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:

  • Provide written informed consent
  • Age 18 years and over
  • New diagnosis of permanent atrial fibrillation (diagnosis within the last 6 weeks) with at least one risk factor for stroke

Exclusion criteria:

  • No further follow-up envisaged or possible within enrolling hospital or with associated family practitioner.
  • Patients with a transient cause for atrial fibrillation which is reversible

Inclusion criteria of Patients for Validation Cohort

  • Provide written informed consent
  • Age 18 years and over
  • Patients of permanent AF, regardless of therapy, with a diagnosis longer than six months before enrolment

Exclusion Criteria for patients of Validation Cohort Patients for whom no further follow-up can be envisaged or possible within enrolling hospital or with associated family practitioner will be excluded

  Contacts and Locations
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

Locations
Australia, New South Wales
Penny Astridge Not yet recruiting
Cardiff, New South Wales, Australia, 2285
Principal Investigator: Penny Astridge            
Australia, Tasmania
Bhuwan Singh Not yet recruiting
Launceston, Tasmania, Australia, 7250
Principal Investigator: Bhuwan Singh            
Australia
Harry Gibbs Not yet recruiting
Lismore, Australia, 2480
Principal Investigator: Harry Gibbs            
Austria
Heinz Drexel Not yet recruiting
Feldkirch, Austria, 6807
Principal Investigator: Heinz Drexel            
Marianne Brodmann Recruiting
Graz, Austria, 8036
Principal Investigator: Marianne Brodmann, MD            
Kurt Lenz Not yet recruiting
Linz, Austria, 4014
Principal Investigator: Kurt Lenz            
Johannes Föchterle Not yet recruiting
Linz, Austria, 4040
Principal Investigator: Johannes Föchterle            
Claus Hagn Not yet recruiting
Völs, Austria, 6176
Principal Investigator: Claus Hagn            
Bernd Eber Not yet recruiting
Wels, Austria, 4600
Principal Investigator: Bernd Eber            
Kurt Huber Not yet recruiting
Wien, Austria, 1160
Principal Investigator: Kurt Huber            
Brazil
José Rocha Not yet recruiting
Faria Neto, Curitiba, Brazil, 80215-901
Principal Investigator: José Rocha            
Weimar Barroso Not yet recruiting
Goiânia, Goiás, Brazil, 74223-130
Principal Investigator: Weimar Barroso            
Carlos Scherr Not yet recruiting
Río de Janeiro, Rio de Janeiro, Brazil, 22410-003
Principal Investigator: Carlos Scherr            
Mario Maranhão Not yet recruiting
Curitiba, Brazil, 80320-320
Principal Investigator: Mario Maranhão            
João Souza Neto Not yet recruiting
Fortaleza, Brazil, 60846-190
Principal Investigator: João Souza Neto            
Benito Garbelini Not yet recruiting
Marília, Brazil, 17515-460
Principal Investigator: Benito Garbelini            
Andre Steffens Not yet recruiting
Pelotas, Brazil, 96015-290
Principal Investigator: Andre Steffens            
Dario Sobral- Filho Not yet recruiting
Recife, Brazil, 50100-130
Principal Investigator: Dario Sobral- Filho            
Jefferso Jaber Not yet recruiting
São Paulo, Brazil, 08270-070
Principal Investigator: Jefferso Jaber            
Fábio Lário Not yet recruiting
São Paulo, Brazil, 01323-903
Principal Investigator: Fábio Lário            
Renato Lopes Not yet recruiting
São Paulo, Brazil, 04039-002
Principal Investigator: Renato Lopes            
Patrícia Smith Not yet recruiting
São Paulo, Brazil, 05019-010
Principal Investigator: Patrícia Smith            
Ricardo Pavanello Not yet recruiting
São Paulo, Brazil, 04004-030
Principal Investigator: Ricardo Pavanello            
Dikran Armaganijan Not yet recruiting
São Paulo, Brazil, 04012-180
Principal Investigator: Dikran Armaganijan            
Sponsors and Collaborators
Thrombosis Research Institute
Bayer
Investigators
Study Director: Ajay K Kakkar, MD Thrombosis Research Institute, London, UK
  More Information

Publications:
Emmerich J, Hauzey J-YL, Bath PMW, Connoly SJ. Indication for antithrombotic therapy for atrial fibrillation: reconciling the guidelines with clinical practice. European Heart Journal Supplements 2005;7(Supplement C):C28-C33.

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: April 10, 2013
Health Authority: Austria: Ethikkommission

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013