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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01090362




Trial ID
NCT01090362
Ethics application status
Date submitted
18/03/2010
Date registered
18/03/2010
Date last updated
4/12/2014

Titles & IDs
Public title
Global Anticoagulant Registry in the Field
Scientific title
Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
Secondary ID [1] 0 0
TRI08888
Universal Trial Number (UTN)
Trial acronym
GARFIELD-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death
Timepoint [1] 0 0
4 monthly for 24 mths then annually until 2018
Secondary outcome [1] 0 0
Systemic embolism
Timepoint [1] 0 0
4 monthly for 24 mths then annually until 2018
Secondary outcome [2] 0 0
Heart failure
Timepoint [2] 0 0
4 monthly for 24 mths then annually until 2018
Secondary outcome [3] 0 0
Acute coronary syndromes
Timepoint [3] 0 0
4 monthly for 24 mths then annually until 2018
Secondary outcome [4] 0 0
Therapy persistence
Timepoint [4] 0 0
4 monthly for 24 mths then annually until 2018
Secondary outcome [5] 0 0
Patient satisfaction with oral anticoagulant treatment
Timepoint [5] 0 0
4, 8, 12 and 24 months
Secondary outcome [6] 0 0
Bleeding Events
Timepoint [6] 0 0
4 monthly for 24 mths then annually until 2018
Secondary outcome [7] 0 0
Strokes (Haemorrhagic and thrombotic)
Timepoint [7] 0 0
4 monthly for 24 mths then annually until 2018

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Argentina
State/province [2] 0 0
Tucumán
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Belgium
State/province [4] 0 0
Brasschaat
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paolo
Country [6] 0 0
Canada
State/province [6] 0 0
Hamilton
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
China
State/province [8] 0 0
Beijing
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Prague
Country [10] 0 0
Denmark
State/province [10] 0 0
Frederiksberg
Country [11] 0 0
Egypt
State/province [11] 0 0
Cairo
Country [12] 0 0
Finland
State/province [12] 0 0
Tampere
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
India
State/province [16] 0 0
Bangalore
Country [17] 0 0
Italy
State/province [17] 0 0
Perugia
Country [18] 0 0
Japan
State/province [18] 0 0
Osaka
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Mexico
State/province [20] 0 0
Monterrey
Country [21] 0 0
Netherlands
State/province [21] 0 0
Maastricht
Country [22] 0 0
Norway
State/province [22] 0 0
Oslo
Country [23] 0 0
Poland
State/province [23] 0 0
Warsaw
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Moscow
Country [25] 0 0
Singapore
State/province [25] 0 0
Singapore
Country [26] 0 0
South Africa
State/province [26] 0 0
Johannesburg
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Sweden
State/province [28] 0 0
Stockholm
Country [29] 0 0
Switzerland
State/province [29] 0 0
Zurich
Country [30] 0 0
Thailand
State/province [30] 0 0
Bangkok
Country [31] 0 0
Turkey
State/province [31] 0 0
Istambul
Country [32] 0 0
Ukraine
State/province [32] 0 0
Kiev
Country [33] 0 0
United Arab Emirates
State/province [33] 0 0
Abu Dhabi
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Other
Name
Thrombosis Research Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Birmingham
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Brigham and Women's Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Quintiles, Inc.
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Advanced Drug and Device Services SAS
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Apothecaries Clinical Research
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01090362
Trial related presentations / publications
Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012 Jan;163(1):13-19.e1. doi: 10.1016/j.ahj.2011.09.011. Epub 2011 Nov 20.
Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA; UK GARFIELD Investigators and GARFIELD Steering Committee. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc Disord. 2013 Apr 23;13:31. doi: 10.1186/1471-2261-13-31.
Aalbers J. GARFIELD: a window on the real-life treatment of atrial fibrillation - South Africa joins the GARFIELD registry. Cardiovasc J Afr. 2012 Oct;23(9):528.
Public notes

Contacts
Principal investigator
Name 0 0
Ajay K Kakkar, MD
Address 0 0
Thrombosis Research Institute, London, UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gloria Kayani
Address 0 0
Country 0 0
Phone 0 0
00442073518390
Fax 0 0
Email 0 0
gkayani@tri-london.ac.uk
Contact person for scientific queries