NCT04419012

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

May 13, 2020

Last Update Submit

July 27, 2020

Conditions

Keywords

Atrial fibrillationanticoagulant treatmentapixabandabigatranrivaroxabanvitamin K antagoniststroke prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.

    Through the study completion, an average of 2 months.

  • 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.

Study Arms (2)

Patients with AF treated with VKA

Other: observation

Patients with AF treated with NOAC

Other: observation

Interventions

observation

Patients with AF treated with NOACPatients with AF treated with VKA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with AF hospitalized in a participating center during study period.

You may qualify if:

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

You may not qualify if:

  • hospitalisation for atrial fibrillation ablation
  • death during hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iwona Gorczyca

Kielce, 25-525, Poland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Observation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Iwona Gorczyca, Md,PhD

    Collegium Medicum, Jan Kochanowski University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

May 13, 2020

First Posted

June 5, 2020

Study Start

January 6, 2019

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations