Global Anticoagulant Registry in the Field "GARFIELD-AF"

Recruiting

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial 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.

Patient Involvement

Suitable patients will be identified in the following settings:-Hospital (Neurology, Cardiology, Geriatrics, Internal medicine)-Anticoagulation clinic/system-GP, family practice and community-Emergency roomsInvestigator sites will be representative of the distribution of care settings on a geographical basis. Sites will be randomly selected and invited to participate. All patients satisfying the inclusion/exclusion criteria will be considered for enrolment.Potential patients will be invited to take part in the registry and their medical history checked to exclude any patients not suitable. All patients will be provided with the patient information sheet to take home and discuss with relatives. Written informed consent will be obtained according to local requirements before any registry-related procedures (i.etransfer of data from the medical records to the CRFs) are carried out.Data will be collected at baseline, 4, 8, 12, 16, 20, and 24 months. These time points will be used as markers for collection of all information from the interim period. The aim of data collection will be to accurately capture all planned and unplanned visits, interruptions to treatment and events. All INR results will also be recorded. A log of all patients invited to participate in the registry will be kept for each site.

Outcomes

Type Measure Time Frame Safety Issue
Primary Thromboembolic stroke; Transient ischaemic attack; Systemic embolisation; Frequency of bleeding events (classified as major, clinical relevant non-major and minor); Therapy persistence (rate of discontinuation, duration of time on therapy, reasons for discontinuation); Duration and cause of treatment interruption or suspension; Analysis of major bleeding events with regard to hospitalisation and outcomes; Any healthcare resource use (GP, hospital or clinic visits) as a result of anticoagulation; Mortality; Major adverse cardiac events. For patients treated with VKA additionally: Frequency and timing of monitoring required in maintaining therapeutic anticoagulation; INR recordings in relation to therapeutic range; Use of bridging anticoagulation necessitated by VKA interruption; Outcomes in relation to INR fluctuation; Patient treatment satisfaction using the ACTS questionnaire.
Secondary Peripheral / non-CNS embolism; Heart failure; Myocardial infarction.
Primary Thromboembolic stroke 4 and 6 years Yes
Primary Transient ischaemic attack 4 years and 6years Yes
Primary Systemic embolisation 4 and 6 years Yes
Primary Therapy persistence 4 and 6 years No
Primary Duration and cause of treatment interruption or suspension 4 and 6 years No
Primary Analysis of major bleeding events with regard to hospitalisation and outcomes 4 and 6 years No
Primary Any healthcare resource use (GP, hospital or clinic visits) as a result of anticoagulation 4 and 6 years No
Primary Mortality 4 and 6 years No
Primary MAJOR ADVERSE CARDIAC EVENTS (MACE) 4 and 6 years Yes
Primary Frequency and timing of monitoring required in maintaining therapeutic anticoagulation 4 and 6 years No
Primary INR recordings in relation to therapeutic range 4 and 6 years No
Primary Use of bridging anticoagulation necessitated by vitamin-K antagonist interruption 4 and 6 years No
Secondary Peripheral / non-CNS embolism 4 and 6 years Yes
Secondary Heart failure 4 and 6 years Yes
Secondary Myocardial infarction 4 and 6 years Yes
Primary Death 4 monthly for 24 mths then annually until 2018 No
Secondary Systemic embolism 4 monthly for 24 mths then annually until 2018 No
Secondary Acute coronary syndromes 4 monthly for 24 mths then annually until 2018 No
Secondary Patient satisfaction with oral anticoagulant treatment 4, 8, 12 and 24 months No
Secondary Bleeding Events 4 monthly for 24 mths then annually until 2018 No
Secondary Strokes (Haemorrhagic and thrombotic) 4 monthly for 24 mths then annually until 2018 No

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