Polish Atrial Fibrillation (POL-AF) Registry

Atrial Fibrillation Clinical Trial

— POL-AF  

Official title:

Polish Atrial Fibrillation (POL-AF) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04419012
• Other study ID #: 104/018
• Status: Active, not recruiting
• Start date: January 6, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Jan Kochanowski University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• hospitalisation for atrial fibrillation ablation

• death during hospitalization

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• observation
observation

Locations

Country	Name	City	State
Poland	Iwona Gorczyca	Kielce

Sponsors (2)

Lead Sponsor	Collaborator
Jan Kochanowski University	Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.	Compared data will include: frequency of VKAs vs NOACs prescriptions.	Through the study completion, an average of 2 months.
Secondary	Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.	Compared data will include: demographics, type of AF, medical history, baseline characteristics and concomitant medications.	Through the study completion, an average of 2 months.
Secondary	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.	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.	Through the study completion, an average of 2 months.