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Completed

NCT Number: NCT03217877

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangwon National Univ. Hospital, Chuncheon, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

routine stress testing

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.

No Routine stress testing

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Death

    Time frame: 2 year

  2. Myocardial infarction

    Time frame: 2 year

  3. Unstable angina hospitalization

    Time frame: 2 year

  4. Death or myocardial infarction

    Time frame: 2 year

  5. Any hospitalization

    Time frame: 2 year

    cardiac cause vs. noncardiac cause

  6. Invasive catheterization

    Time frame: 2 year

  7. 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.

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study 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

Acronym: POST PCI

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2017
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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