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
  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:


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.


  Hide Detailed Description

Detailed Description:

The registry will start with the 1st cohort starting in select main countries. There will be GARFIELD representatives on a country specific level during the first cohort. Then there will be a broader extension in subsequent cohorts. No single centre will be able to recruit sufficient number of patients to conduct the assessment and therefore it is proposed to identify a sufficient number of sites in community, hospital, or anticoagulation clinic settings throughout the world. The main focus of this registry is to capture the real-life anticoagulation treatment in the GP setting.

Data Registry: In the setting of clinical trials of stroke prevention in AF, regulatory authorities mandate a very tight control of anticoagulant therapy resulting in lower rates of therapeutic failure than usually seen in real-life clinical practice, making accurate assessment of the value of antithrombotic agents difficult.

Source Data: Data will be derived from the patients clinical records according to specifications outlined in the electronic case record form. This registry will not undertake any experimental intervention with patients being treated to normal local practice and with any coagulation investigations being performed as to normal routine. No additional tests or procedures are required by the protocol. Patient progress and events will be monitored for a minimum of 2 years from inclusion. Patients will be identified from multiple sources including the hospital (neurology, cardiology, geriatrics, internal medicine, and emergency room), anticoagulant clinic and general / family practice setting, and the identifying clinician will register the patient using the on-line electronic CRF. Thereafter, data on outcomes relevant to the registry will be collected from 4 clinical sources associated with the patient - hospital, emergency room, anticoagulation clinic and general / family practitioner, but these data will be collected on a four monthly basis through review of patient notes and clinical records.

Source data verification will be undertaken in five per cent of all cases. All data will be summarised or transcribed in the CRF from documents considered to be source data.

Validation Cohort will be added to the first cohort to register patients in select countries. 5000 patients with permanent AF enrolled will be enrolled.

The patients registered will be diagnosed with permanent atrial fibrillation, regardless of therapy, with a diagnosis history longer than six months prior to enrolment 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 .

Allocation of Treatments This is a non-interventional, multi-centre, prospective registry and patients will be treated according to normal local practice.

Evaluations will be performed by the local clinical sites according to their routine. No change in routine practice will be required or encouraged in the registry.

Duration of Patient Participation It is anticipated that the total registry duration will be 6 years for all 5 cohorts allowing 4 years for recruitment and 2 years of follow up for each patient.

Discontinuation Criteria

  1. Patients As this is a data registry there are no specific withdrawal criteria. However, the patient is free to withdraw consent at any time.
  2. Entire Registry It is agreed that for reasonable cause either the Investigator or the sponsor, may terminate this registry before the expiration of the agreed time period, provided a written notice is submitted at a reasonable time in advance of intended termination.

Prospective Cohorts (Patient selection) It is proposed to identify a sufficient number of sites globally in hospital, community or anticoagulation clinic settings throughout the world to ensure representation in major countries with focus on the GP setting. 50,000 patients with newly diagnosed permanent AF with at least one additional risk factor for stroke will be enrolled in order to collect a representative sample. Patients will be enrolled as 5 independent cohorts of 10,000 patients each. An 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.

All patients in each cohort will be identified and registered consecutively. 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.

  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.

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: 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 April 16, 2014