Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF) (NOAC)

Thromboembolic and Bleeding Risk During Anticoagulant Treatment in Asian Patents With Atrial Fibrillation

This study was design to investigate the efficacy and safety of NOAC therapy in Koreans

Study Overview

Status

Enrolling by invitation

Detailed Description

East Asians have demonstrated a higher bleeding tendency compared to Western populations during an anticoagulation. Consequently, East Asians have been prescribed as a relatively weaker treatment regimens based on this evidence. Therefore, the TARGET-AF study aims to verify the efficacy and safety of NOAC therapy using biomarkers including TEG®-6S point-of-care device in Koreans

Study Type

Observational

Enrollment (Estimated)

1021

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

      • Gwangmyeong, South Korea
        • Chung-Ang University Gwangmyeong Hospital
      • Seoul, South Korea, 06973
        • Chung-Ang University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

AF patients with NOAC

Description

Inclusion Criteria:

  • Patients with documented AF on 12-lead ECG, Holter monitoring, or single-lead ECG recordings are eligible for enrollment.
  • Based on AF treatment Korean guideline 19, AF patients who require NOAC treatment or are currently on NOAC treatment (within the past 3 months)
  • Adults aged 18 or above who have provided consent for clinical information

Exclusion Criteria:

  • Patients with moderate or severe mitral stenosis or mechanical prosthetic valve

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

Cohorts and Interventions

Group / Cohort
Atrial Fibrillation
Documented AF on 12-lead ECG, Holter monitoring, or single-lead ECG recordings and biomarkers using TEG®-6S with NOAC treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical ischemic and hemorrhagic events
Time Frame: 12 months
The Rate of Ischemic stroke, systemic embolism, or myocardial infarction and ISTH (International Society on Thrombosis and Hemostasis) major/minor bleeding events
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical other events
Time Frame: 12 months
The rate of Major Adverse Cardiovascular Events: Myocardial infarction, ischemic stroke, systemic embolism, and cardiovascular death (including bleeding).
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 infection
Time Frame: 12 months
The rate of confirmation of COVID-19 infection and primary outcome
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

May 25, 2022

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 20, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

CAUH 1992-002-387

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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