NCT06881901

Brief Summary

To evaluate the long-term outcomes of different antiplatelet strategies, including DAPT, aspirin monotherapy, and clopidogrel monotherapy, in CCS patients undergoing CABG. A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29,898

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

13 years

First QC Date

March 10, 2025

Last Update Submit

March 11, 2025

Conditions

Chronic Coronary SyndromeCoronary Artery Bypass Graft CABG

Keywords

antiplatelet drugDual antiplatelet therapySingle antiplatelet therapy

Outcome Measures

Primary Outcomes (2)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    Composite of all cause death, spontaneous MI, and stroke

    10 year after CABG

  • Major GI bleeding

    Major GI bleeding requiring transfusion

    10 year after CABG

Secondary Outcomes (5)

  • All cause death

    10 year after CABG

  • Spontaneous myocardial infarction

    10 year after CABG

  • Stroke

    10 year after CABG

  • Repeat revascularization

    10 year after CABG

  • Bleeding evet

    10 year after CABG

Study Arms (3)

Dual antiplatelet therapy

Patients who were prescribed dual antiplatelet therapy (aspirin + clopidogrel) at the date of discharge from te index hospitalization for CABG

Aspirin monotherapy

Patients who were prescribed single antiplatelet therapy (aspirin) at the date of discharge from te index hospitalization for CABG

Clopidogrel monotherapy

Patients who were prescribed single antiplatelet therapy (clopidogrel) at the date of discharge from te index hospitalization for CABG

Eligibility Criteria

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

Patients who were prescribed antiplatete therapy after undergoing CABG

You may qualify if:

  • Patients with underwent Coronary artery bypass surgery (CABG) between January 2010 and December 2020

You may not qualify if:

  • In-hospital death
  • Not prescribed SAPT or DAPT
  • Received CABG due to myocardial infarction or had myocardial infarction
  • Received CABG due to unstable angina or had unstable angina
  • History of PCI
  • Pre-existing Intracranial hemorrhage or gastrointestinal bleeding
  • Oral anticoagulant prescription at discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 18, 2025

Study Start

January 1, 2010

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share