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

April 3, 2022 updated by: Seung-Jung Park

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Gangwon National Univ. Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Seongnam, Korea, Republic of
        • Bundang CHA Hospital
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, 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
      • Suwon, Korea, Republic of
        • The Catholic University of Korea, St. Vincent'S Hospital
      • Wonju, Korea, Republic of
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: No Routine stress testing after PCI
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.
Experimental: Routine stress testing at 9~15 months after PCI
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
composite of major cardiovascular events
Time Frame: 2 year
a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.
2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 2 year
2 year
Myocardial infarction
Time Frame: 2 year
2 year
Unstable angina hospitalization
Time Frame: 2 year
2 year
Death or myocardial infarction
Time Frame: 2 year
2 year
Any hospitalization
Time Frame: 2 year
cardiac cause vs. noncardiac cause
2 year
Invasive catheterization
Time Frame: 2 year
2 year
Repeat revascularization procedure
Time Frame: 2 year
Repeat revascularization procedure during follow-up; target vs. non-target lesion (or vessel), ischemia-driven vs. not ischemia-driven.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CardioVascular Research Foundation, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMCCV2017-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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