Atrial Fibrillation Data Linkage Non-Interventional Study
November 17, 2025 updated by: Pfizer
Temporal Changes in Clinical Characteristics and Functions, and Their Relationship With Outcomes of Atrial Fibrillation: a Retrospective Study Utilizing Data Linkage of a Single Center Patient Data and National Claims Database in Korea
The purpose of this study is to understand temporal changes in clinical features and functions, and the relationship with outcomes of atrial fibrillation (AF).
AF is a problem with speed or pattern that the heart beats.
It is the most common type of arrythmia.
The study will use data linkage of a single center patient data and national claims database in Korea.
This study does not include an actual patient enrollment process.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
12556
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, South Korea
- Pfizer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
This study will include adult patients with Atrial Fibrillation diagnosis code at Seould National Universit Hospital(SNUH) from Jan 2010 to Dec 2020.
Description
Inclusion Criteria:
- Patients had incident AF diagnosis (International Classification of Diseases 10th Revision [ICD-10]; I48) in an inpatient or outpatient setting at SNUH between 1 Jan 2010 and 31 Dec 2020
- Patients aged 18 years or older on the index date
Exclusion Criteria:
- Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis, or prosthetic heart valve during 12 months period prior to first AF diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Event Rate of Stroke/Systemic embolism (SE)
Time Frame: Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatment
|
National Health Insurance Service(NHIS) Claims with the following ICD-10 diagnosis codes as main or all sub-diagnoses whichever came first (i.e., the first occurred event will be used):
|
Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatment
|
|
Event Rate of Major bleeding
Time Frame: Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment
|
Bleeding requiring hospitalization will be identified using hospital claims which had a bleeding diagnosis code as the first occurred ICD-10 code and will be consisted of intracranial hemorrahge (ICH), gastrointestinal (GI) bleeding, and other bleeding.
Main and all sub-diagnosis codes will be used.
Particularly, hospitalization and brain CT or MRI codes (as described in variable 'stroke or SE') will be needed to identify ICH.
|
Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment
|
|
All-Cause Mortality Rates
Time Frame: Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment
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Death will be identified from mortality registration data of Statistics Korea linked to NHIS database
|
Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2025
Primary Completion (Actual)
October 23, 2025
Study Completion (Actual)
October 23, 2025
Study Registration Dates
First Submitted
March 15, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 12, 2023
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B0661188
- Eliquis AF data linkage NIS (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.