NCT03871127

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

March 7, 2019

Last Update Submit

June 18, 2020

Conditions

Coronary Artery Disease

Keywords

PCICABGLeft main

Outcome Measures

Primary Outcomes (1)

  • Composite outcome

    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 Outcomes (10)

  • All-cause mortality

    10 year

  • Cardiac death

    10 year

  • Myocardial infarction

    10 year

  • Cerebrovascular accident

    10 year

  • Target vessel revascularization

    10 year

  • +5 more secondary outcomes

Study Arms (1)

Left main coronary disease

Procedure: Percutaneous coronary interventionProcedure: coronary artery bypass graft

Interventions

Percutaneous coronary interventionPROCEDURE

Using sirolimus eluting stent

Left main coronary disease
coronary artery bypass graftPROCEDURE

coronary artery bypass graft

Left main coronary disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subject group enrolled in PRECOMBAT trial

You may qualify if:

  • Subject group enrolled in PRECOMBAT trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chonnam National University Hospital

Gwangju, South Korea

Location

Seoul National University Bundang hospital

Seongnam, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (4)

  • Yang Y, Jeong YJ, Hyun J, Lee J, Kim JH, Kim S, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; PRECOMBAT Investigators. Prognostic Value of Sex After Revascularization for Left Main Coronary Disease: Extended PRECOMBAT Study. JACC Asia. 2021 Nov 9;2(1):19-29. doi: 10.1016/j.jacasi.2021.08.009. eCollection 2022 Feb.

    PMID: 36340254DERIVED

  • Jeong YJ, Ahn JM, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Park H, Kang DY, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ, Park DW. Ten-year Outcomes After Drug-Eluting Stents or Bypass Surgery for Left Main Coronary Disease in Patients With and Without Diabetes Mellitus: The PRECOMBAT Extended Follow-Up Study. J Am Heart Assoc. 2021 Jul 20;10(14):e019834. doi: 10.1161/JAHA.120.019834. Epub 2021 Jul 9.

    PMID: 34238026DERIVED

  • Lee J, Ahn JM, Kim JH, Jeong YJ, Hyun J, Yang Y, Lee JS, Park H, Kang DY, Lee PH, Park DW, Park SJ; on the behalf of the PRECOMBAT Investigators. Prognostic Effect of the SYNTAX Score on 10-Year Outcomes After Left Main Coronary Artery Revascularization in a Randomized Population: Insights From the Extended PRECOMBAT Trial. J Am Heart Assoc. 2021 Jul 20;10(14):e020359. doi: 10.1161/JAHA.120.020359. Epub 2021 Jul 6.

    PMID: 34227392DERIVED

  • Park DW, Ahn JM, Park H, Yun SC, Kang DY, Lee PH, Kim YH, Lim DS, Rha SW, Park GM, Gwon HC, Kim HS, Chae IH, Jang Y, Jeong MH, Tahk SJ, Seung KB, Park SJ; PRECOMBAT Investigators. Ten-Year Outcomes After Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Disease: Extended Follow-Up of the PRECOMBAT Trial. Circulation. 2020 May 5;141(18):1437-1446. doi: 10.1161/CIRCULATIONAHA.120.046039. Epub 2020 Mar 30.

    PMID: 32223567DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary InterventionCoronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresMyocardial RevascularizationCardiac Surgical ProceduresVascular GraftingThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 12, 2019

Study Start

May 1, 2019

Primary Completion

February 24, 2020

Study Completion

February 24, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

KR(9)