MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: paroxysmal, persistent, long-standing persistent or permanent AF valvular or non-valvular AF treatment with OACs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin) Exclusion criteria: lack of OAC at hospital discharge

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acenocoumarol<br>Patients with AF treated with acenocoumarol. | |
| Warfarin<br>Patients with AF treated with warfarin. | |
| Apixaban<br>Patients with AF treated with apixaban. | |
| Dabigatran<br>Patients with AF treated with dabigatran. | |
| Rivaroxaban<br>Patients with AF treated with rivaroxaban. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE) | 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. | Through the study completion, an average of 3 months. | 
| Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital | 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. | Through the study completion, an average of 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Non-vitamin K Oral Anticoagulants, Vitamin K Antagonists, ROCKET-AF, RE-LY, ARISTOTLE