Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

NCT06281041 | Completed DMC

• 1 other identifier: NHIS20240220
• Study Type: observational
• Target: 4,657
• Locations: 1 country
• Sites: 1

Brief 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). 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).

Conditions

Coronary Artery Disease; Coronary Artery Stenosis

Keywords

Coronary artery stenosis; Antiplatelet agent; Fractional flow reserve; Prognosis

Outcome Measures

Primary Outcomes (2)

• Major adverse cardiac and cerebrovascular events

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

  at 5 years from index procedure

• Gastrointestinal bleeding

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

  at 5 years from index procedure

Secondary Outcomes (7)

• All-cause death

  at 5 years from index procedure

• Myocardial infarction

  at 5 years from index procedure

• Unplanned revascularization

  at 5 years from index procedure

• Stroke

  at 5 years from index procedure

• Major bleeding

  at 5 years from index procedure

Study Arms (2)

Antiplatelet agents

Among 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.

Drug: Antiplatelet Agents

No antiplatelet agents

Among 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.

Interventions

Antiplatelet Agents DRUG

Aspirin or clopidogrel

Also known as: aspirin, clopidogrel

Antiplatelet agents

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Chonnam National University: collaborator

Study Sites (1)

Chonnam National University Medical School

Gwangju, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Platelet Aggregation Inhibitors; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Danbee Kang, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2013
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)