Polish Atrial Fibrillation (POL-AF) Registry

• Conditions: Atrial Fibrillation
• Interventions: Other: observation

• Registration Number: NCT04419012
• Lead Sponsor: Jan Kochanowski University

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.

Study Timeline

• Study Start: 2019-01-06
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Primary Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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

Exclusion Criteria

• hospitalisation for atrial fibrillation ablation
• death during hospitalization

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with AF treated with NOAC	observation	-
Patients with AF treated with VKA	observation	-

Primary Outcome Measures

Name	Time	Method
Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.	Through the study completion, an average of 2 months.	Compared data will include: frequency of VKAs vs NOACs prescriptions.

Secondary Outcome Measures

Name	Time	Method
Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.	Through the study completion, an average of 2 months.	Compared data will include: demographics, type of AF, medical history, baseline characteristics and concomitant medications.
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.	Through the study completion, an average of 2 months.	The CHA2DS2-VAS score includes the following factors: heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex.; According to the CHA2DS2-VAS score, high thromboembolic risk means 2 points in men, 3 points in women.; Data on the components of CHA2DS2-VASC are obtained from medical records.

Trial Locations

Locations (1)

Iwona Gorczyca; 🇵🇱 Kielce, Poland