Clinical trial NCT02987062: MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT)
Official title: CRAFT - Multicenter Experience in Atrial Fibrillation Patients Treated With OAC (CRAFT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Non-vitamin K Oral Anticoagulants
Vitamin K Antagonists
ROCKET-AF
RE-LY
ARISTOTLE
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include patients with AF treated with VKAs (acenocoumarol, warfarin) and NOACs (apixaban, dabigatran, riwaroxaban), hospitalized in 2011-2016 years in the First Department of Cardiology of Medical University of Warsaw and hospitalized in 2014-2016 in the John Paul II Western Hospital in Grodzisk Mazowiecki, Poland.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)
timeFrame: Through the study completion, an average of 3 months.
measure: Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital
timeFrame: Through the study completion, an average of 3 months.
Secondary outcomes:
measure: Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs
timeFrame: Through the study completion, an average of 3 months.
measure: Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)
timeFrame: Through the study completion, an average of 3 months.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: 1st Department of Cardiology Medical University of Warsaw
state: Mazowiecki
city: Grodzisk Mazowiecki
country: Poland
facility: John Paul II Western Hospital
Study officials:
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Grzegorz Opolski, Professor
role: STUDY_CHAIR
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Marcin Grabowski, PhD
role: STUDY_CHAIR
References:
citation: Balsam P, Tyminska A, Ozieranski K, Zaleska M, Zukowska K, Szepietowska K, Maciejewski K, Peller M, Grabowski M, Lodzinski P, Koltowski L, Praska-Oginska A, Zaboyska I, Bednarski J, Filipiak KJ, Opolski G. Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients? Cardiol J. 2020;27(5):590-599. doi: 10.5603/CJ.a2018.0135. Epub 2018 Nov 8.