Atrial Fibrillation Clinical Trial
Official title:
CRAFT - Multicenter Experience in Atrial Fibrillation Patients Treated With OAC (CRAFT)
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.
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.
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