NCT04686045

Brief Summary

Prevention of thromboembolic complications is an important part in the management of patients with atrial fibrillation (AF). European and American guidelines recommend the use of non-vitamin K antagonist oral anticoagulants (NOACs) over therapy with vitamin K antagonists (VKA) in most AF patients. The number of patients treated with NOACs has increased significantly during the last few years. In the primary randomized controlled trials leading to their approval, compared to warfarin, NOACs were shown to be either noninferior or superior for stroke prevention in AF, with similar or reduced rates of bleeding, especially intracranial haemorrhage. The aim of this study was to assess the frequency of oral anticoagulants using, espescially apixaban, dabigatran, and rivaroxaban, and the predictors of their prescription in a group of hospitalised patients with 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
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

December 22, 2020

Last Update Submit

January 24, 2021

Conditions

Atrial Fibrillation; Stroke Prevention

Outcome Measures

Primary Outcomes (1)

  • oral anticoagulant treatment

    one year

Interventions

observational studyOTHER

observational study

Eligibility Criteria

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

All patients with AF treated in hospital.

You may qualify if:

  • \- non-valvular atrial fibrillation

You may not qualify if:

  • valvular atrial fibrillation
  • death during hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1st Clinic of Cardiology and Electotherapy

Kielce, Grunwaldzka 45, 25-637, Poland

RECRUITING

Iwona Gorczyca

Kielce, 25-525, Poland

RECRUITING

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 Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

January 1, 2021

Primary Completion

March 1, 2021

Study Completion

May 1, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

PL(2)