Atrial Fibrillation Data Linkage Non-Interventional Study

NCT05810727 | Completed

• 2 other identifiers: B0661188Eliquis AF data linkage NIS
• Study Type: observational
• Target: 12,556
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Event Rate of Stroke/Systemic embolism (SE)

  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): 1. Ischemic stroke: G45.9, I63, I69.3 2. Hemorragic stroke: I60, I61, I62, I69.0, I69.1, I69.2 3. Systemic embolism: I74 * Hospitalization and computed tomography (CT) or magnetic resonance imaging (MRI) codes (brain CT or MRI for ischemic stroke and hemorrhagic stroke; any CT or MRI for systemic embolism) were also required for identification.

  Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatment

• Event Rate of Major bleeding

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 12, 2023
• Study Start: August 21, 2025
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)