NCT06874894

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,021

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2022Aug 2026

Study Start

First participant enrolled

May 25, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

March 8, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

Atrial FibrillationStrokeBleeding

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (1)

  • Clinical other events

    12 months

Other Outcomes (1)

  • COVID-19 infection

    12 months

Study Arms (1)

Atrial Fibrillation

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

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AF patients with NOAC

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 36857519BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationStrokeHemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 13, 2025

Study Start

May 25, 2022

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

CAUH 1992-002-387

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations