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Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention — NHIS  

Coronary Artery Disease Clinical Trial

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

Clinical 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). 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06281041
Study type Observational
Source Samsung Medical Center
Contact
Status Active, not recruiting
Phase
Start date January 1, 2013
Completion date December 31, 2024
View Details
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