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

NCT ID: NCT03217877

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease With Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Routine stress testing after PCI

Group Type ACTIVE_COMPARATOR

No Routine stress testing

Intervention Type DIAGNOSTIC_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.

Routine stress testing at 9~15 months after PCI

Group Type EXPERIMENTAL

routine stress testing

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seung-Jung Park

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Duk-woo Park, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Bundang CHA Hospital

Seongnam, , South Korea

Site Status

Seoul National University Bundang hospital

Seongnam, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Eulji General Hospital

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

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

Suwon, , South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 41043864 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38922632 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38418002 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36036496 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMCCV2017-05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.