Global Anticoagulant Registry in the Field

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01090362
• Lead Sponsor: Thrombosis Research Institute

Brief Summary

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).

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.

Study Timeline

• Study Start: 2009-12-21
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2019-06-16
• Study Completion: 2020-05-18
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57250

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	4 years	All cause mortality including cardiovascular and non-cardiovascular death
Stroke/Systemic embolism (SE)	4 years	Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Major bleeding	4 years	Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.

Secondary Outcome Measures

Name	Time	Method
Incidences of other clinical events	4 years	Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Bleeding Events	4 years	Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Cerebrovascular events defined as Stroke	4 years	Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Transient Ischemic Attacks (TIA)	4 years	Number of Transient Ischemic Attacks (TIA)
Acute coronary syndromes	4 years	Number including unstable angina, STEMI, Non-STEMI
Therapy persistence	4 years	Participant duration of time on therapy
Pulmonary Embolism	4 years	Number of participants with a Pulmonary Embolism

Trial Locations

Locations (35)

Prof. Samuel Goldhaber; 🇺🇸 Boston, Massachusetts, United States

Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman; 🇦🇷 Tucumán, Argentina

Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital; 🇦🇺 Melbourne, Australia

Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz; 🇦🇹 Graz, Austria

Dr Frank Cools, National Co-ordinating Investigator, AZ Klina; 🇧🇪 Brasschaat, Belgium

Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,; 🇧🇷 São Paulo, Brazil

Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University; 🇨🇦 Hamilton, Canada

Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile; 🇨🇱 Santiago, Chile

Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital; 🇨🇳 Beijing, China

Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital; 🇨🇿 Prague, Czechia

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