Fibrillation, AtrialNOACNCT06874894
Thromboembolic And Bleeding Risks During anticoaGulant trEatment in Asian paTients With Atrial Fibrillation (TARGET-AF)
An observational study of Fibrillation, Atrial, run by Chung-Ang University Hospital at 2 sites in South Korea.
Trial summary
This study was design to investigate the efficacy and safety of NOAC therapy in Koreans Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Fibrillation, Atrial
- How many people
- 1,021 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 May 2022to 30 Aug 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AF patients with NOAC
Who may be able to join
- 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
Who cannot join
- Patients with moderate or severe mitral stenosis or mechanical prosthetic valve
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Chung-Ang University Hospital
Seoul, 06973
About this study
Official title: 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
Read the 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
- Conditions
- Fibrillation, Atrial
- Keywords
- Atrial Fibrillation, Stroke, Bleeding
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Clinical ischemic and hemorrhagic events
The Rate of Ischemic stroke, systemic embolism, or myocardial infarction and ISTH (International Society on Thrombosis and Hemostasis) major/minor bleeding events
Measured: 12 months
Secondary outcomes (1)
Clinical other events
The rate of Major Adverse Cardiovascular Events: Myocardial infarction, ischemic stroke, systemic embolism, and cardiovascular death (including bleeding).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start25 May 2022
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibrillation, AtrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,021 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University Gwangmyeong Hospital, Samsung Medical Center, Korea University Ansan Hospital, Kosin University Gospel Hospital, Keimyung University Dongsan Medical Center, Yuhan Corporation
- Responsible party
- Principal investigator, Ki-Woon Kang, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874894
- Sponsor's protocol ID
- CAUH 1992-002-387
- Acronym
- NOAC
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CAUH 1992-002-387
Publications
Lee SH, Kim HK, Ahn JH, Kang MG, Kim KH, Bae JS, Cho SY, Koh JS, Park Y, Hwang SJ, Gorog DA, Tantry US, Bliden KP, Gurbel PA, Hwang JY, Jeong YH. Prognostic impact of hypercoagulability and impaired fibrinolysis in acute myocardial infarction. Eur Heart J. 2023 May 14;44(19):1718-1728. doi: 10.1093/eurheartj/ehad088.
PubMed 36857519
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboembolic and Bleeding Risk During Anticoagulant Treatment in Asian Patents With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06874894
- Acronym / sponsor ID
- NOAC / CAUH 1992-002-387
- Conditions
- Fibrillation, Atrial
- Keywords
- Atrial Fibrillation, Stroke, Bleeding
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,021 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Collaborators
- Chung-Ang University Gwangmyeong Hospital, Samsung Medical Center, Korea University Ansan Hospital, Kosin University Gospel Hospital, Keimyung University Dongsan Medical Center, Yuhan Corporation
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was design to investigate the efficacy and safety of NOAC therapy in Koreans
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | –Documented AF on 12-lead ECG, Holter monitoring, or single-lead ECG recordings and biomarkers using TEG®-6S with NOAC treatment |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AF patients with NOAC
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with moderate or severe mitral stenosis or mechanical prosthetic valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Clinical other events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 36857519Lee SH, Kim HK, Ahn JH, Kang MG, Kim KH, Bae JS, Cho SY, Koh JS, Park Y, Hwang SJ, Gorog DA, Tantry US, Bliden KP, Gurbel PA, Hwang JY, Jeong YH. Prognostic impact of hypercoagulability and impaired fibrinolysis in acute myocardial infarction. Eur Heart J. 2023 May 14;44(19):1718-1728. doi: 10.1093/eurheartj/ehad088.
- Individual participant dataSharing planned: Yes. CAUH 1992-002-387
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrillation, Atrial, run by Chung-Ang University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical ischemic and hemorrhagic events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06874894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.