- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874894
Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF) (NOAC)
December 20, 2025 updated by: Ki-Woon Kang, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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
Conditions
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAUH 1992-002-387
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.