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NCT Number: NCT06281041

Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Stenosis Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Medical School

Gwangju, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Antiplatelet Agents

Drug

Aspirin or clopidogrel

Other names: aspirin, clopidogrel

Primary outcomes

  1. Major adverse cardiac and cerebrovascular events

    Time frame: at 5 years from index procedure

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

  2. Gastrointestinal bleeding

    Time frame: at 5 years from index procedure

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

Secondary outcomes

  1. All-cause death

    Time frame: at 5 years from index procedure

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

  2. Myocardial infarction

    Time frame: at 5 years from index procedure

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

  3. Unplanned revascularization

    Time frame: at 5 years from index procedure

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

  4. Stroke

    Time frame: at 5 years from index procedure

    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.

  5. Major bleeding

    Time frame: at 5 years from index procedure

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

  6. Gastrointestinal bleeding necessitated hospitalization without documented transfusion

    Time frame: at 5 years from index procedure

    Gastrointestinal bleeding necessitated hospitalization without documented transfusion

  7. Intracranial hemorrhage

    Time frame: at 5 years from index procedure

    Intracranial hemorrhage

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Chonnam National University

Registry information

Official study title

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

Acronym: NHIS

Important dates

Study start
2013
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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