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

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ClinicalTrials.gov Identifier: NCT03217877
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease With Myocardial Infarction Diagnostic Test: routine stress testing Diagnostic Test: No Routine stress testing Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217877


Contacts
Contact: Duk-woo Park, MD 82230104812 dwpark@amc.seoul.kr

Locations
Korea, Republic of
Gangwon National Univ. Hospital Active, not recruiting
Chuncheon, Korea, Republic of
Chungnam National University Hospital Recruiting
Dae-jeon, Korea, Republic of
Contact: Si-Wan Choi, MD       siwanc@cnu.ac.kr   
Principal Investigator: Si-wan Choi, MD         
Daegu Catholic University Medical Center Active, not recruiting
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Seung-Ho Huh, MD       shur@dsmc.or.kr   
Principal Investigator: Seung-Ho Huh, MD         
The Catholic University of Korea, Daejeon ST. Mary's Hospital Terminated
Daejeon, Korea, Republic of
Chonnam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of
Contact: Myoung-Ho Jung, MD       myungho@chollian.net   
Principal Investigator: Myoung-Ho Jung, MD         
Inje University Ilsan Paik Hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: Sung-wook Kwon, MD       mdksu@paik.ac.kr   
Principal Investigator: Sung-wook Kwon, MD         
ChonBuk National University Hospital Active, not recruiting
Jeonju, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD         
Eulji General Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae-woong Choi, MD       cjw1108@eulji.ac.kr   
Principal Investigator: Jae-woong Choi, MD         
Kyung hee university hospital at Kangdong Withdrawn
Seoul, Korea, Republic of
The Catholic University of Korea St. Paul's Hospital Terminated
Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: CHEOL-SU PARK, MD       charlie@catholic.ac.kr   
Principal Investigator: CHEOL-SU PARK, MD         
Bundang CHA Hospital Recruiting
Sungnam, Korea, Republic of
Contact: Won-jang Kim, MD       mdwjkim@gmail.com   
Principal Investigator: Won-jang Kim, MD         
Seoul National University Bundang hospital Recruiting
Sungnam, Korea, Republic of
Contact: Jung-won Suh, MD       suhjw1@gmail.com   
Principal Investigator: Jung-won Suh, MD         
The Catholic university of Korea, ST. Vincent's Hospital Recruiting
Suwon, Korea, Republic of
Contact: Su-nam Lee, MD       yellow-night@hanmail.net   
Principal Investigator: Su-nam Lee, MD         
Wonju Severance Christian Hospital Active, not recruiting
Wonju, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Duk-woo Park, MD Asan Medical Center

Responsible Party: Seung-Jung Park, professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03217877     History of Changes
Other Study ID Numbers: AMCCV2017-05
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seung-Jung Park, Asan Medical Center:
noninvasive stress testing
high risk
unstable angina
PCI

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Ischemia
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases