Coronary Artery DiseasePRECOMBATNCT03871127
Ten-Year Outcomes of PRE-COMBAT Trial
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 9 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention and coronary artery bypass graft
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 1 May 2019to 24 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject group enrolled in PRECOMBAT trial
Who may be able to join
- Subject group enrolled in PRECOMBAT trial
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Chonnam National University Hospital
Gwangju
Seoul National University Bundang hospital
Seongnam
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Ajou University Hospital
Suwon
Ulsan University Hospital
Ulsan
About this study
Official title: 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).
Read the detailed description
This study is an extended one of PRECOMBAT trial.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention, coronary artery bypass graft
- Keywords
- PCI, CABG, Left main
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Using sirolimus eluting stent
coronary artery bypass graftProcedure or surgery
coronary artery bypass graft
| Study group | Role | What they receive |
|---|---|---|
| Left main coronary disease | Not described Receives: Procedure: Percutaneous coronary intervention; Procedure: coronary artery bypass graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 year
Secondary outcomes (10)
All-cause mortality
Measured: 10 year
Cardiac death
Measured: 10 year
Myocardial infarction
Measured: 10 year
Cerebrovascular accident
Measured: 10 year
Target vessel revascularization
Measured: 10 year
Target lesion revascularization
Measured: 10 year
Stent thrombosis
Measured: 10 year
Binary restenosis in both in-stent and in-segment
Measured: 10 year
Graft reocclusion rate
Measured: 10 year
Graft patency rate
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 May 2019
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871127
- Sponsor's protocol ID
- AMCCV2019-02
- Acronym
- PRECOMBAT
- Status last verified
- Jun 2020
- First submitted
- 7 Mar 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36340254Jeong 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.
PubMed 34238026Lee 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.
PubMed 34227392Park 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.
PubMed 32223567
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03871127
- Acronym / sponsor ID
- PRECOMBAT / AMCCV2019-02
- Conditions
- Coronary Artery Disease
- Keywords
- PCI, CABG, Left main
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 1 May 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is an extended one of PRECOMBAT trial.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left main coronary disease | – | Procedure: Percutaneous coronary intervention, Procedure: coronary artery bypass graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject group enrolled in PRECOMBAT trial
Key inclusion criteria (1 listed)
- Subject group enrolled in PRECOMBAT trial
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionUsing sirolimus eluting stent | Procedure or surgery | Left main coronary disease |
| coronary artery bypass graftcoronary artery bypass graft | Procedure or surgery | Left main coronary disease |
Primary outcome
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 secondary outcomes
All-cause mortality
Time frame: 10 year
Cardiac death
Time frame: 10 year
Myocardial infarction
Time frame: 10 year
Cerebrovascular accident
Time frame: 10 year
Target vessel revascularization
Time frame: 10 year
Target lesion revascularization
Time frame: 10 year
Stent thrombosis
Time frame: 10 year
Binary restenosis in both in-stent and in-segment
Time frame: 10 year
Graft reocclusion rate
Time frame: 10 year
Graft patency rate
Time frame: 10 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 36340254Yang 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.
- Derived from this study: PubMed 34238026Jeong 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.
- Derived from this study: PubMed 34227392Lee 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.
- Derived from this study: PubMed 32223567Park 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (time frame: 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871127, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.