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Coronary Artery Disease With Myocardial InfarctionPOST PCINCT03217877

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

A study testing routine stress testing and No Routine stress testing in people with Coronary Artery Disease With Myocardial Infarction, run by Seung-Jung Park at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
routine stress testing and No Routine stress testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,700 participants
Where
11 sitesSouth Korea
Study dates
15 Nov 2017to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject was > 19 years of age.
  • 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.
  • 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
  • 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.

Who cannot join

  • Cardiogenic shock at the index admission
  • Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
  • Pregnant and/or lactating women.
  • Concurrent medical condition with a life expectancy of less than 1 years
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Gangwon National Univ. Hospital

    Chuncheon

  • Daegu Catholic University Medical Center

    Daegu

  • Keimyung University Dongsan Medical Center

    Daegu

  • Chungnam National University Hospital

    Daejeon

  • Bundang CHA Hospital

    Seongnam

  • Seoul National University Bundang hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Eulji General Hospital

    Seoul

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul

  • The Catholic university of Korea, ST. Vincent's Hospital

    Suwon

  • Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

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

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.

Being tested
routine stress testing, No Routine stress testing
Keywords
noninvasive stress testing, high risk, unstable angina, PCI
Medical subject headings
Coronary Artery Disease, Autosomal Dominant, 1, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • routine stress testingDiagnostic test

    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 testingDiagnostic test

    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.

Study groups in NCT03217877
Study groupRoleWhat they receive
No Routine stress testing after PCIActive comparatorNot described
Receives: Diagnostic Test: No Routine stress testing
Routine stress testing at 9~15 months after PCIExperimentalNot described
Receives: Diagnostic Test: routine stress testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite of major cardiovascular events

    a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.

    Measured: 2 year

Secondary outcomes (7)

  1. Death

    Measured: 2 year

  2. Myocardial infarction

    Measured: 2 year

  3. Unstable angina hospitalization

    Measured: 2 year

  4. Death or myocardial infarction

    Measured: 2 year

  5. Any hospitalization

    cardiac cause vs. noncardiac cause

    Measured: 2 year

  6. Invasive catheterization

    Measured: 2 year

  7. Repeat revascularization procedure

    Repeat revascularization procedure during follow-up; target vs. non-target lesion (or vessel), ischemia-driven vs. not ischemia-driven.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2017
  2. Study start15 Nov 2017
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03217877
Sponsor's protocol ID
AMCCV2017-05
Acronym
POST PCI
Status last verified
Apr 2022
First submitted
13 Jul 2017
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Choi Y, Kang DY, Kim H, Lee J, Jo S, Ahn JM, Kim N, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW; POST-PCI Investigators. Role of routine surveillance stress testing in patients with or without imaging-guided or physiology-guided PCI. Heart. 2025 Oct 2:heartjnl-2025-326402. doi: 10.1136/heartjnl-2025-326402. Online ahead of print.

    PubMed 41043864

  • Lee J, Kang DY, Kim H, Choi Y, Jo S, Ahn JM, Kim S, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW. Routine Stress Testing After PCI in Patients With and Without Acute Coronary Syndrome: A Secondary Analysis of the POST-PCI Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):770-780. doi: 10.1001/jamacardio.2024.1556.

    PubMed 38922632

  • Lee JM, Kim H, Park YS, Jo HH, Lim SM, Lee J, Choi Y, Kang DY, Ahn JM, Kim S, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW; POST-PCI Investigators. Surveillance Stress Testing After Percutaneous Intervention for Patients With Multivessel or Left Main Coronary Disease. J Am Coll Cardiol. 2024 Mar 5;83(9):890-900. doi: 10.1016/j.jacc.2023.12.027.

    PubMed 38418002

  • Park DW, Kang DY, Ahn JM, Yun SC, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Yoon JH, Choi JW, Kim KS, Choi SW, Lee SN, Park SJ; POST-PCI Investigators. Routine Functional Testing or Standard Care in High-Risk Patients after PCI. N Engl J Med. 2022 Sep 8;387(10):905-915. doi: 10.1056/NEJMoa2208335. Epub 2022 Aug 28.

    PubMed 36036496

Questions about this trial

What is this clinical trial studying?

A study testing routine stress testing and No Routine stress testing in people with Coronary Artery Disease With Myocardial Infarction, run by Seung-Jung Park at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite of major cardiovascular events (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03217877, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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