Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention

Coronary Artery Disease With Myocardial Infarction Clinical Trial

— POST PCI  

Official title:

a Multi-center, Open-label, Nationwide Registry-based, Randomized, Pragmatic Trial Comparing 2 Post-PCI Management Strategies in High-risk PCI Patients With Complex Clinical and Lesion Characteristics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217877
• Other study ID #: AMCCV2017-05
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Subject was > 19 years of age.

2. Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion.

3. Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.

3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).

3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (= 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length =30 mm or stent length =32 mm), or vein bypass graft stented

4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Cardiogenic shock at the index admission

2. Subject treated with only bare metal stent or balloon angioplasty during the index procedure.

3. Pregnant and/or lactating women.

4. Concurrent medical condition with a life expectancy of less than 1 years

5. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

6 Subject was unable to provide written informed consent or participate in long-term follow-up.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease With Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• routine stress testing
In the group of routine stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed at 9~15 months after the procedure according to the practice pattern of each participating center.
• No Routine stress testing
In the group of symptom oriented stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed when chest pain or angina symptom is occured after the procedure according to the practice pattern of each participating center.

Locations

Country	Name	City	State
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Seoul National University Bundang hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic university of Korea, ST. Vincent's Hospital	Suwon
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of major cardiovascular events	a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.	2 year
Secondary	Death		2 year
Secondary	Myocardial infarction		2 year
Secondary	Unstable angina hospitalization		2 year
Secondary	Death or myocardial infarction		2 year
Secondary	Any hospitalization	cardiac cause vs. noncardiac cause	2 year
Secondary	Invasive catheterization		2 year
Secondary	Repeat revascularization procedure	Repeat revascularization procedure during follow-up; target vs. non-target lesion (or vessel), ischemia-driven vs. not ischemia-driven.	2 year