Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57,250
- 试验地点
- 35
- 主要终点
- Death
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Death
时间窗: 4 years
All cause mortality including cardiovascular and non-cardiovascular death
Stroke/Systemic embolism (SE)
时间窗: 4 years
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Major bleeding
时间窗: 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.
次要结局
- Incidences of other clinical events(4 years)
- Bleeding Events(4 years)
- Cerebrovascular events defined as Stroke(4 years)
- Transient Ischemic Attacks (TIA)(4 years)
- Acute coronary syndromes(4 years)
- Therapy persistence(4 years)
- Pulmonary Embolism(4 years)