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Coronary Artery DiseaseNHISNCT06281041

Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

An observational study of Coronary Artery Disease and Coronary Artery Stenosis, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR). Read more about this study

Who is it for?
Any age
What is being tested?
Antiplatelet Agents
How many people
4,657 participants
Where
1 siteSouth Korea
Study dates
1 Jan 2013to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: From 2013 to 2020, the use of FFR has been reimbursed by insurance criteria for patients with 50-70% intermediate stenosis by quantitative coronary angiography in a vessel greater than 2.5 mm in the absence of prior evidence of inducible myocardial ischemia by non-invasive tests. The current study included participants who underwent FFR but did not receive revascularization, meaning that they had 50-70% intermediate stenosis and revascularization was deferred based on negative FFR between 2013 and 2020.

Who may be able to join

  • Patients with 50-70% intermediate stenosis by quantitative coronary angiography in a vessel greater than 2.5 mm
  • Patients who underwent invasive coronary angiography and FFR measurement
  • Patients whose revascularization was deferred based on FFR>0.80

Who cannot join

  • Patients who underween FFR measurement after expansion of reimbursement criteria of FFR (since 2021)
  • Patients with history of any bleeding with blood transfusion
  • Patients with use of non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin
  • Patients with previous atherosclerotic cardiovascular disease
  • Patients with already on antiplatelet agents including dual antiplatelet agents

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonnam National University Medical School

    Gwangju

Other trials in South Korea

About this study

Official title: Antiplatelet Agents in Patients With Intermediate Coronary Artery Stenosis and Negative Fractional Flow Reserve

There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR).

Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR>0.80).

Read the detailed description

This study was nationwide cohort study conducted using Korean National Health Insurance Service database. From 2013 to 2020, reimbursement criteria of FFR were patients with no previous evidence of myocardial ischemia and intermediate coronary artery stenosis (50-70%). Patients who were evaluated by coronary angiography and FFR but did not undergo revascularization were selected and classified according to the use of antiplatelet agents after index procedure. Patients with previous history of atherosclerotic cardiovascular disease were excluded. Eligible patients were matched using propensity score in a 1:1 ratio. Primary efficacy outcome was major adverse cardiac and cerebrovascular events a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke at 5-year. Primary safety outcome was gastrointestinal bleeding, regardless of the need of transfusion.

Being tested
Antiplatelet Agents
Keywords
Coronary artery stenosis, Antiplatelet agent, Fractional flow reserve, Prognosis
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiplatelet AgentsDrug

    Also called aspirin, clopidogrel

    Aspirin or clopidogrel

Study groups in NCT06281041
Study groupRoleWhat they receive
Antiplatelet agentsAmong patients with intermediate coronary artery stenosis (50-70% diameter stenosis by quantitative coronary angiography) but who did not undergo PCI based on negative FFR, those who were taking antiplatelet agents (aspirin or clopidogrel) are classified into this group.
Receives: Drug: Antiplatelet Agents
No antiplatelet agentsAmong patients with intermediate coronary artery stenosis (50-70% diameter stenosis by quantitative coronary angiography) but who did not undergo PCI based on negative FFR, those who were not taking antiplatelet agents (aspirin or clopidogrel) are classified into this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiac and cerebrovascular events

    Primaey efficacy ouotcome (MACCE, a composite of all-cause death, myocardial infarction, unplanned revascularization, and stroke)

    Measured: at 5 years from index procedure

  2. Gastrointestinal bleeding

    Primary safety outcome (any gastrointestinal bleeding, regardless of the need of transfusion)

    Measured: at 5 years from index procedure

Secondary outcomes (7)

  1. All-cause death

    All-cause death which was obtained from death certification collected by Statistics Korea at the Ministry of Strategy and Finance of South Korea.

    Measured: at 5 years from index procedure

  2. Myocardial infarction

    Myocardial infarction is defined as presence of the diagnostic codes (ICD-10 I21, I22) in the primary position during hospitalization

    Measured: at 5 years from index procedure

  3. Unplanned revascularization

    Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index hospitalization

    Measured: at 5 years from index procedure

  4. Stroke

    Stroke is defined as ischemic stroke (ICD-10 I63, I64) or intracranial hemorrhage (ICD-10 I60-62), combined with the codes of diagnostic brain imaging.

    Measured: at 5 years from index procedure

  5. Major bleeding

    Major bleeding is defined as a composite of intracranial bleeding or gastrointestinal bleeding with documented transfusion.

    Measured: at 5 years from index procedure

  6. Gastrointestinal bleeding necessitated hospitalization without documented transfusion

    Gastrointestinal bleeding necessitated hospitalization without documented transfusion

    Measured: at 5 years from index procedure

  7. Intracranial hemorrhage

    Intracranial hemorrhage

    Measured: at 5 years from index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Jan 2013
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

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
4,657 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06281041
Sponsor's protocol ID
NHIS20240220
Acronym
NHIS
Status last verified
Mar 2025
First submitted
20 Feb 2024
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is National Helath Insurance Data Analysis. therefore, sharing the original patient-level data is not possible under regulation by Korean Govenment.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Coronary Artery Stenosis, run by Samsung Medical Center at 1 site 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 5 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: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major adverse cardiac and cerebrovascular events (time frame: at 5 years from index procedure). The study lists 2 primary outcomes in all. 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 NCT06281041.

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 14 Mar 2025.

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