Myocardial Infarction, AcuteNCT04626882
Timing of FFR-guided PCI for Non-IRA in STEMI and MVD (OPTION-STEMI)
A study testing Staged in-hospital or Immediate complete revascularization in people with Myocardial Infarction, Acute and Multi-Vessel Coronary Artery Stenosis, run by Chonnam National University Hospital at 14 sites in South Korea.
Trial summary
Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Infarction, Acute, Multi-Vessel Coronary Artery Stenosis
- What is being tested?
- Staged in-hospital or Immediate complete revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 994 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 30 Dec 2019to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years old
- ST-segment elevation myocardial infarction
- ST-segment elevation in at least 2 contiguous leads or,
- New onset left bundle branch block
- Primary PCI within 12 hours after symptom development
- Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
- Patient's or protector's agreement about study design and the risk of PCI
Who cannot join
- Cardiogenic shock at initial presentation or after treatment of IRA
- Unprotected left main coronary artery disease with at least 50% diameter stenosis by visual estimation
- TIMI (Thrombolysis in Myocardial Infarction) flow at non-IRA ≤ 2
- Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
- Non-IRA lesion not suitable for PCI treatment by operators' decision
- Chronic total occlusion at non-IRA
Show all 14Show fewer
- History of anaphylaxis to contrast agent
- Pregnancy and lactation
- Life expectancy < 1-year
- Severe valvular disease
- History of CABG (coronary artery bypass graft), or planned CABG
- Fibrinolysis before admission
- Severe asthma
- Patient's refusal to participate in study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si
Gyeongsang National University Changwon Hospital
Changwon
Yeongnam University Medical Center
Daegu
GangNeung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
Chonbuk National University Hospital
Jeonju
Presbyterian Medical Center
Jeonju
Gyeongsang National University Hospital
Jinju
Koera University Guro Hospital
Seoul
Kyung Hee University Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
St. Carollo General Hospital
Suncheon
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si
Yonsei University, Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease (OPTION-STEMI)
Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR (fractional flow reserve) evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Read the detailed description
Study objectives:
To determine the optimal timing of non-infarct related artery (IRA) percutaneous coronary intervention (PCI) with the aid of FFR (fractional flow reserve) (immediate complete revascularization during primary angioplasty vs. staged procedure for non-IRA PCI) in patients with ST-segment elevation myocardial infarction with multivessel disease (MVD).
Study hypothesis:
Complete revascularization (CR) at index procedure is not inferior to staged in-hospital CR in patients with STEMI and MVD who undergoing FFR-guided revascularization for non-IRA.
Background:
Multivessel coronary artery disease (MVD) is a common clinical condition, about 40-65% of all primary angioplasty, encountered by interventional cardiologists in ST-segment elevation myocardial infarction (STEMI), and it is associated with poorer clinical outcomes than single-vessel disease. Older guidelines recommended culprit-vessel only revascularization (CVR) during primary angioplasty, except in patient that are hemodynamically unstable. Several recent studies have reported improved clinical outcomes in these patients with multivessel percutaneous coronary intervention (PCI), and others reported promising results from CVR followed by elective second-stage PCI at non-infarct related artery (non-IRA) with significant stenosis. However, there has been no consensus of optimal revascularization strategy in this circumstance.
Recently, several large-scaled randomized controlled trials were conducted about this issue, and confirmed the benefit of immediate complete revascularization during primary angioplasty compared to CVR. Furthermore, fractional flow reserve (FFR)-guided PCI at non-IRA was more effective than angiography-guided PCI at non-IRA for reducing repeat revascularization by either immediate multivessel PCI strategy or staged PCI strategy in the other trials.
Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis, the most studies regarding FFR enrolled patients without acute myocardial infarction (AMI). Timing of non-IRA PCI is also uncertain. After promising results of above-mentioned randomized trials, current guideline recommendation of multivessel PCI (immediate or staged) was upgraded. However, current guidelines simply mentioned about the timing of non-IRA PCI which recommends complete revascularization during initial hospitalization by either of immediate of staged PCI strategy.
Therefore, the investigators planned to perform prospective, open-label, multicenter, non-inferiority trial to evaluate the efficacy and safety of immediate complete revascularization (PCI for both IRA and non-IRA during primary angioplasty) compared to staged PCI strategy of non-IRA (primary angioplasty for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 70% should be conducted with the aid of FFR, and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
Study procedure:
Patients will be randomized after primary PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
- Being tested
- Staged in-hospital or Immediate complete revascularization
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staged in-hospital or Immediate complete revascularizationProcedure or surgery
Patients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
| Study group | Role | What they receive |
|---|---|---|
| Staged in-hospital CR (complete revascularization) | Active comparator | Non-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. Receives: Procedure: Staged in-hospital or Immediate complete revascularization |
| Immediate CR (complete revascularization) | Experimental | Non-infarct related artery (IRA) will be revascularized immediately after PCI for IRA (during primary PCI). Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. Receives: Procedure: Staged in-hospital or Immediate complete revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention
Measured: Index admission to 12 months
Secondary outcomes (15)
Rate of contrast-induced nephropathy during index admission
Rate of contrast-induced nephropathy during index admission
Measured: During index admission
Cumulative incidence rate of all unplanned revascularization at each visit
Cumulative incidence rate of all unplanned revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-lesion revascularization at each visit
Cumulative incidence rate of target-lesion revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-vessel revascularization at each visit
Cumulative incidence rate of target-vessel revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-target vessel revascularization at each visit
Cumulative incidence rate of non-target vessel revascularization at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death at each visit
Cumulative incidence rate of all-cause death at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of cardiac death at each visit
Cumulative incidence rate of cardiac death at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-cardiac death at each visit
Cumulative incidence rate of non-cardiac death at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-fatal myocardial infarction at each visit
Cumulative incidence rate of non-fatal myocardial infarction at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for unstable angina at each visit
Cumulative incidence rate of hospitalization for unstable angina at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for heart failure at each visit
Cumulative incidence rate of hospitalization for heart failure at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of definite or probable stent thrombosis at each visit
Cumulative incidence rate of definite or probable stent thrombosis at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit
Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit
Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention
Measured: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start30 Dec 2019
- Primary completion15 Jan 2025
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 994 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Chul Kim, Chonnam National University Hospital
- Investigators
- Youngkeun Ahn, MD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626882
- Sponsor's protocol ID
- CNUH-2019-318
- Status last verified
- Jul 2026
- First submitted
- 2 Nov 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho KH, Kim MC, Ahn JH, Hyun DY, Lim Y, Lee SH, Park S, Oh S, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Lee JH, Jeong YH, Ahn JH, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Park JI, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Immediate Complete Revascularization During Index Admission in Older Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2026 Oct 22:S1936-8798(26)02426-X. doi: 10.1016/j.jcin.2026.08.025. Online ahead of print.
PubMed 42925297Kim MC, Ahn JH, Hyun DY, Lim Y, Cho KH, Lee SH, Park S, Oh S, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Lee JH, Jeong YH, Ahn JH, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Park JI, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial. Lancet. 2025 Sep 6;406(10507):1032-1043. doi: 10.1016/S0140-6736(25)01529-6. Epub 2025 Aug 31.
PubMed 40902612Kim MC, Ahn JH, Hyun DY, Lim Y, Lee SH, Oh S, Cho KH, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Jeong YH, Park Y, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Lee JH, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial. Am Heart J. 2024 Jul;273:35-43. doi: 10.1016/j.ahj.2024.03.017. Epub 2024 Apr 18.
PubMed 38641031
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimal TIming of Fractional Flow Reserve-Guided Complete RevascularizatiON for Non-Infarct Related Artery in ST-Segment Elevation Myocardial Infarction With Multivessel Disease (OPTION-STEMI)
- ClinicalTrials.gov ID
- NCT04626882
- Acronym / sponsor ID
- CNUH-2019-318
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 994 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Nov 2020 (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.
Patients with STEMI (ST-segment elevation myocardial infarction) with multivessel disease which have PCI (percutaneous coronary intervention)-suitable non-IRA (infarct related artery) will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR (fractional flow reserve) evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Detailed description
Study objectives:
To determine the optimal timing of non-infarct related artery (IRA) percutaneous coronary intervention (PCI) with the aid of FFR (fractional flow reserve) (immediate complete revascularization during primary angioplasty vs. staged procedure for non-IRA PCI) in patients with ST-segment elevation myocardial infarction with multivessel disease (MVD).
Study hypothesis:
Complete revascularization (CR) at index procedure is not inferior to staged in-hospital CR in patients with STEMI and MVD who undergoing FFR-guided revascularization for non-IRA.
Background:
Multivessel coronary artery disease (MVD) is a common clinical condition, about 40-65% of all primary angioplasty, encountered by interventional cardiologists in ST-segment elevation myocardial infarction (STEMI), and it is associated with poorer clinical outcomes than single-vessel disease. Older guidelines recommended culprit-vessel only revascularization (CVR) during primary angioplasty, except in patient that are hemodynamically unstable. Several recent studies have reported improved clinical outcomes in these patients with multivessel percutaneous coronary intervention (PCI), and others reported promising results from CVR followed by elective second-stage PCI at non-infarct related artery (non-IRA) with significant stenosis. However, there has been no consensus of optimal revascularization strategy in this circumstance.
Recently, several large-scaled randomized controlled trials were conducted about this issue, and confirmed the benefit of immediate complete revascularization during primary angioplasty compared to CVR. Furthermore, fractional flow reserve (FFR)-guided PCI at non-IRA was more effective than angiography-guided PCI at non-IRA for reducing repeat revascularization by either immediate multivessel PCI strategy or staged PCI strategy in the other trials.
Although FFR is a well-known tool to evaluate significant ischemia of moderate stenosis, the most studies regarding FFR enrolled patients without acute myocardial infarction (AMI). Timing of non-IRA PCI is also uncertain. After promising results of above-mentioned randomized trials, current guideline recommendation of multivessel PCI (immediate or staged) was upgraded. However, current guidelines simply mentioned about the timing of non-IRA PCI which recommends complete revascularization during initial hospitalization by either of immediate of staged PCI strategy.
Therefore, the investigators planned to perform prospective, open-label, multicenter, non-inferiority trial to evaluate the efficacy and safety of immediate complete revascularization (PCI for both IRA and non-IRA during primary angioplasty) compared to staged PCI strategy of non-IRA (primary angioplasty for IRA followed by non-IRA PCI after several days). PCI procedure at non-IRA with diameter stenosis between 50 and 70% should be conducted with the aid of FFR, and non-IRA with diameter stenosis ≥ 70% will be revascularized without FFR.
Study procedure:
Patients will be randomized after primary PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staged in-hospital CR (complete revascularization) | Active comparator | Procedure: Staged in-hospital or Immediate complete revascularizationNon-infarct related artery (IRA) will be revascularized in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. |
| Immediate CR (complete revascularization) | Experimental | Procedure: Staged in-hospital or Immediate complete revascularizationNon-infarct related artery (IRA) will be revascularized immediately after PCI for IRA (during primary PCI). Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 19 years old
- ST-segment elevation myocardial infarction
- Primary PCI within 12 hours after symptom development
- Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
- Patient's or protector's agreement about study design and the risk of PCI
Key exclusion criteria (14 listed)
- Cardiogenic shock at initial presentation or after treatment of IRA
- Unprotected left main coronary artery disease with at least 50% diameter stenosis by visual estimation
- TIMI (Thrombolysis in Myocardial Infarction) flow at non-IRA ≤ 2
- Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
- Non-IRA lesion not suitable for PCI treatment by operators' decision
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 |
|---|---|---|
| Staged in-hospital or Immediate complete revascularizationPatients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized. | Procedure or surgery | Immediate CR (complete revascularization), Staged in-hospital CR (complete revascularization) |
Primary outcome
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
Time frame: Index admission to 12 months
Composite endpoint of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year after index percutaneous coronary intervention
15 secondary outcomes
Rate of contrast-induced nephropathy during index admission
Time frame: During index admission
Cumulative incidence rate of all unplanned revascularization at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-lesion revascularization at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of target-vessel revascularization at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-target vessel revascularization at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of cardiac death at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-cardiac death at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of non-fatal myocardial infarction at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for unstable angina at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of hospitalization for heart failure at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of definite or probable stent thrombosis at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of ischemic and hemorrhagic stroke at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of major bleeding (BARC definitions type 3 or 5) at each visit
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline
Time frame: Index admission, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 42925297Cho KH, Kim MC, Ahn JH, Hyun DY, Lim Y, Lee SH, Park S, Oh S, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Lee JH, Jeong YH, Ahn JH, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Park JI, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Immediate Complete Revascularization During Index Admission in Older Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2026 Oct 22:S1936-8798(26)02426-X. doi: 10.1016/j.jcin.2026.08.025. Online ahead of print.
- Derived from this study: PubMed 40902612Kim MC, Ahn JH, Hyun DY, Lim Y, Cho KH, Lee SH, Park S, Oh S, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Lee JH, Jeong YH, Ahn JH, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Park JI, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial. Lancet. 2025 Sep 6;406(10507):1032-1043. doi: 10.1016/S0140-6736(25)01529-6. Epub 2025 Aug 31.
- Derived from this study: PubMed 38641031Kim MC, Ahn JH, Hyun DY, Lim Y, Lee SH, Oh S, Cho KH, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Jeong YH, Park Y, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Lee JH, Yoo SY, Ahn Y; OPTION-STEMI Investigators. Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial. Am Heart J. 2024 Jul;273:35-43. doi: 10.1016/j.ahj.2024.03.017. Epub 2024 Apr 18.
- Individual participant dataSharing planned: No
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CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Youngkeun Ahn, MD principal investigator
Chonnam National University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staged in-hospital or Immediate complete revascularization in people with Myocardial Infarction, Acute and Multi-Vessel Coronary Artery Stenosis, run by Chonnam National University Hospital at 14 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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
This study is still under way. Results are not available in the source record yet.
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?
Cumulative incidence rate of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization at 1 year from baseline (time frame: Index admission to 12 months). 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 NCT04626882, which also lists 3 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 7 Jul 2026.