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临床试验/NCT02563639
NCT02563639已完成不适用

APAF Apixaban in Atrial Fibrillation Registry

IHF GmbH - Institut für Herzinfarktforschung1 个研究点 分布在 1 个国家目标入组 5,015 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,015
试验地点
1
主要终点
Comparison of antithrombotic therapy for atrial fibrillation: Prescribed drugs

研究概览

简要总结

Objective of the registry is to assess the use of antithrombotic therapies and adherence to guidelines in patients with non-valvular atrial fibrillation.

详细描述

Atrial fibrillation (AF) confers a substantial risk of mortality and morbidity from stroke and thromboembolism, and this common cardiac arrhythmia represents a major healthcare burden in Europe. Stroke prevention is central to the management of AF patients, with oral anticoagulation (OAC) using well-controlled adjusted dose vitamin K antagonists or novel OACs being recommended for patients with AF with ≥1 stroke risk factors. Also, the 2012 focused update of the ESC guidelines strongly advocates a clinical practice shift so that the initial decision step now is the identification of 'truly low risk' patients, essentially those age<65 without any stroke risk factors (both male and female), who do not need any antithrombotic therapy. The ESC guidelines only recommend use of the CHA2DS2-VASc score for stroke risk assessment, and the 'low risk' patients are defined as those with a CHA2DS2-VASc score=0 (males) or score=1 (females). Subsequent to this initial step of identifying the low risk patients, effective stroke prevention (which is essentially OAC) can then be offered to AF patients with ≥1 stroke risk factors, with treatment decisions made in consultation with patients and incorporating their preferences. Despite these recommendations, a substantial number of patients with AF is not treated with OAC. On the other hand, patients with AF and low risk are being "overtreated", receiving OAC despite a CHADS-VASc score of 0. Therefore, this registry will determine, if patients with non-valvular AF are treated ac-cording to current guidelines.

Apixaban is an oral factor Xa inhibitor, which has been tested in a number of indications. In the AVERROES study in patients with non-valvular atrial fibrillation deemed not suitable for treatment with a vitamin-K antagonist apixaban compared to aspirin reduced the incidence of stroke and systemic embolism without increasing bleeding complications. In the large ARISTOTELE study apixaban was superior to warfarin, it re-duced the primary endpoint of stroke and systemic embolism caused less bleeding and reduced all-cause mortality. Subsequently apixaban has been approved by the European health authorities for the use in patients with atrial fibrillation. It is therefore of interest to determine use of apixaban in real life with respect to patient selection, adherence to therapy and midterm efficacy and safety.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Age ≥18 years
  • Non-valvular atrial fibrillation
  • In hospitals or specialized or non-specialised office-based centres
  • Written informed consent for participation in observational study (incl. telephone follow-ups)
  • Not simultaneously participating in any randomized trial

排除标准

  • No exclusion criteria

结局指标

主要结局

Comparison of antithrombotic therapy for atrial fibrillation: Prescribed drugs

时间窗: 12 months

Name of antithrombotic drug

次要结局

  • Safety of Apixaban as assessed by MACCE, Haemorrhagic complications, Ischemic clinical events, Stroke, Systemic embolism, Hospitalisations for stroke, cardiac reasons or bleeding complications(12 months)
  • Subjective Quality of Life(12 months)
  • Comparison of antithrombotic therapy for atrial fibrillation: Dose of drugs(12 months)
  • Comparison of antithrombotic therapy for atrial fibrillation: Duration of treatment(12 months)
  • Comparison of antithrombotic therapy for atrial fibrillation: Contraindications for anticoagulation(12 months)
  • Comparison of antithrombotic therapy for atrial fibrillation:Selection of anticoagulant(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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