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临床试验/NCT02987062
NCT02987062Unknown不适用

CRAFT - Multicenter Experience in Atrial Fibrillation Patients Treated With OAC (CRAFT)

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
2
主要终点
Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)

研究概览

简要总结

According to current guidelines for non-valvular atrial fibrillation treatment, the first line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on real-life clinical practice.

The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs) in an academic and district hospital, with regard to inclusion/exclusion criteria used in the clinical trials.

详细描述

Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular morbidity and mortality. An integral element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants and vitamin K antagonists are two main drugs groups used in treatment.

Primary objective of the study is to assess the treatment of AF patients with OACs (the frequency of prescription of VKAs vs NOACs), compare the clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE) and population gathered from the university department and the district hospital. Secondary objective of the study is to assess the long-term outcomes of patients with AF treated with OACs.

The CRAFT (MultiCenter expeRience in AFib patients Treated with OAC) is a multicenter retrospective analysis of hospital records of patients with AF managed in the First Department of Cardiology of Medical University of Warsaw and in John Paul II Western Hospital in Grodzisk Mazowiecki. Gathered data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics (i.e. blood pressure), laboratory investigations (blood tests, including renal and hepatic function), echocardiographic parameters and concomitant medications. Data will be collected from the moment of patient's discharge.

Each patient will be evaluated regarding to common and new scales assessing risk of thromboembolic (CHA2DS2-VASc ) and bleeding (HAS-BLED, HEMORR2HAGES, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events, as well as SAMeTT2R2 score to predict the quality of treatment on OACs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)

时间窗: Through the study completion, an average of 3 months.

Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.

Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital

时间窗: Through the study completion, an average of 3 months.

Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.

次要结局

  • Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs(Through the study completion, an average of 3 months.)
  • Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)(Through the study completion, an average of 3 months.)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcin Grabowski

Clinical Professor, Marcin Grabowski, Medical University of Warsaw

Medical University of Warsaw

研究点 (2)

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