Ten-Year Outcomes of PRE-COMBAT Trial (PRECOMBAT)

June 18, 2020 updated by: Seung-Jung Park

Ten-Year Outcomes of PREmier of Randomized Comparison of Sirolimus-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for Unprotected Left Main Coronary Artery Stenosis: PRE-COMBAT Trial

This study evaluates Ten-Year Outcomes of PREmier of Randomized Comparison of Sirolimus-Eluting Stent Implantation Versus Coronary Artery Bypass Surgery for Unprotected Left Main Coronary Artery Stenosis(PRECOMBAT trial).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is an extended one of PRECOMBAT trial.

Study Type

Observational

Enrollment (Actual)

600

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
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subject group enrolled in PRECOMBAT trial

Description

Inclusion Criteria:

  • Subject group enrolled in PRECOMBAT trial

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Left main coronary disease
Procedure: Percutaneous coronary intervention
Using sirolimus eluting stent
Procedure: coronary artery bypass graft
coronary artery bypass graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome
Time Frame: 10 year
The composite of death, myocardial infarction, and revascularization. Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, and revascularization
10 year

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 10 year
10 year
Cardiac death
Time Frame: 10 year
10 year
Myocardial infarction
Time Frame: 10 year
10 year
Cerebrovascular accident
Time Frame: 10 year
10 year
Target vessel revascularization
Time Frame: 10 year
10 year
Target lesion revascularization
Time Frame: 10 year
10 year
Stent thrombosis
Time Frame: 10 year
10 year
Binary restenosis in both in-stent and in-segment
Time Frame: 10 year
10 year
Graft reocclusion rate
Time Frame: 10 year
10 year
Graft patency rate
Time Frame: 10 year
10 year

Collaborators and Investigators

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

Sponsor

Seung-Jung Park

Collaborators

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)

May 1, 2019

Primary Completion (Actual)

February 24, 2020

Study Completion (Actual)

February 24, 2020

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 10, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2019-02

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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