NCT06876727

Brief Summary

This study was a target trial emulation using the National Health Claims database established by the Korean National Health Insurance Service (K-NHIS). 8,325 patients were included.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 1, 2003

Completed
20.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

20.8 years

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

Abdominal Aortic Aneurysms (AAA)Endovascular Aneurysm Repair (EVAR)Single antiplatelet therapyDual antiplatelet therapy

Outcome Measures

Primary Outcomes (3)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    composite of all-cause death, myocardial infarction (MI), or ischemic stroke

    1 year after EVAR

  • Major or clinically relevant non-major bleeding

    Diagnostic codes in the primary or secondary position and transfusion receipt

    1 year after EVAR

  • Re-intervention or surgery for AAAs

    Re-intervention or surgery for AAAs

    1 year after EVAR

Study Arms (2)

Dual antiplatelet therapy

Patients who were prescribed dual antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR

Single antiplatelet therapy

Patients who were prescribed single antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent EVAR for AAA and were successfully discharged and prescribe any antiplatelet therapy.

You may qualify if:

  • All patients who underwent EVAR for AAA and were successfully discharged

You may not qualify if:

  • Patients who had experienced a myocardial infarction
  • Patients who had experienced a stroke
  • Patients who had experienced percutaneous coronary intervention
  • Patients who had history of peripheral disease
  • Patients who had major bleeding event within 1 year of admission
  • Those prescribed non-vitamin K antagonist oral anticoagulant or warfarin
  • Patients who did not prescribe any antiplatelet therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Choi KH, Kang D, Nam J, Park TK, Song MG, Seo TS, Yang WJ, Choi SH. Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair: A Target Trial Emulation. J Am Heart Assoc. 2025 Oct 21;14(20):e044102. doi: 10.1161/JAHA.125.044102. Epub 2025 Oct 9.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

January 1, 2003

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share