Clinical trial NCT04419012: Polish Atrial Fibrillation (POL-AF) Registry
Official title: Polish Atrial Fibrillation (POL-AF) Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
anticoagulant treatment
apixaban
dabigatran
rivaroxaban
vitamin K antagonist
stroke prevention
Lead sponsor: Jan Kochanowski University
Sponsor class: OTHER
Collaborators: name: Medical University of Warsaw
First posted: 2020-06-05
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with AF hospitalized in a participating center during study period.

Brief summary: Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients with atrial fibrillation (AF).

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

Primary objective of the study is to assess the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.

Secondary objective of the study are as follows: assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients and assesment of the number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc score.

The POL-AF Registry is a multicenter prospective analysis of hospital records of patients with AF managed in ten cardiology centers.

Collected data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic parameters and concomitant medications.

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

Eligibility criteria: Inclusion Criteria:

- patients with AF hospitalized in a participating center during study period

Exclusion Criteria:

* hospitalisation for atrial fibrillation ablation
* death during hospitalization

Primary 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 2 months.
Secondary outcomes:
measure: Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.
timeFrame: Through the study completion, an average of 2 months.
measure: Number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc (heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex) score.
timeFrame: Through the study completion, an average of 2 months.
Other outcomes:
Locations:
city: Kielce
country: Poland
facility: Iwona Gorczyca
Study officials:
affiliation: Collegium Medicum, Jan Kochanowski University
name: Iwona Gorczyca, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uzieblo-Zyczkowska B, Krzesinski P, Maciorowska M, Gorczyca I, Jelonek O, Wojcik M, Blaszczyk R, Kaplon-Cieslicka A, Gawalko M, Tokarek T, Rajtar-Salwa R, Bil J, Wojewodzki M, Szpotowicz A, Krzciuk M, Bednarski J, Bakula-Ostalska E, Tomaszuk-Kazberuk A, Szyszkowska A, Welnicki M, Mamcarz A, Wozakowska-Kaplon B. Antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, including compliance with current guidelines-data from the POLish Atrial Fibrillation (POL-AF) Registry. Cardiovasc Diagn Ther. 2021 Feb;11(1):14-27. doi: 10.21037/cdt-20-839.