Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

Coronary Artery Disease Clinical Trial

— NHIS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06281041
• Other study ID #: NHIS20240220
• Status: Active, not recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4657
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Drug:
• Antiplatelet Agents
Aspirin or clopidogrel

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Medical School	Gwangju

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Chonnam National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gastrointestinal bleeding	Primary safety outcome (any gastrointestinal bleeding, regardless of the need of transfusion)	at 5 years from index procedure
Secondary	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.	at 5 years from index procedure
Secondary	Myocardial infarction	Myocardial infarction is defined as presence of the diagnostic codes (ICD-10 I21, I22) in the primary position during hospitalization	at 5 years from index procedure
Secondary	Unplanned revascularization	Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index hospitalization	at 5 years from index procedure
Secondary	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.	at 5 years from index procedure
Secondary	Major bleeding	Major bleeding is defined as a composite of intracranial bleeding or gastrointestinal bleeding with documented transfusion.	at 5 years from index procedure
Secondary	Gastrointestinal bleeding necessitated hospitalization without documented transfusion	Gastrointestinal bleeding necessitated hospitalization without documented transfusion	at 5 years from index procedure
Secondary	Intracranial hemorrhage	Intracranial hemorrhage	at 5 years from index procedure