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.
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.
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.
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.
|Type||Measure||Time Frame||Safety Issue|
|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|