AzTrials
AzTrials

Myocardial Infarction (MI)NCT07741721

Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)

A study testing In-hospital staged complete revascularization and Out-of-hospital staged complete revascularization in people with Myocardial Infarction (MI), run by Chonnam National University Hospital at 30 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Myocardial Infarction (MI)
What is being tested?
In-hospital staged complete revascularization and Out-of-hospital staged complete revascularization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,252 participants
Where
30 sitesSouth Korea
Study dates
21 Aug 2026to 31 Jul 2035
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
  • ST-segment elevation myocardial infarction (STEMI): ST-segment elevation ≥ 0.1 mV in at least two contiguous leads, or New-onset left bundle branch block (LBBB)
  • Primary PCI within 12 h after symptom development
  • At least 1 non-infarct related artery (non-IRA) with diameter ≥ 2.5 mm and 50% stenosis by visual estimation

Who cannot join

  • Cardiogenic shock at initial presentation or after infarct-related artery (IRA) treatment
  • Thrombolysis in myocardial infarction flow at non-IRA ≤ 2
  • Severe procedural complications during primary percutaneous coronary intervention that, in the judgement of the operator, preclude study enrollment
  • Non-IRA lesion unsuitable for percutaneous coronary intervention (PCI) treatment that, in the judgement of the operator, preclude study enrollment
  • Chronic total occlusion in a non-IRA
  • History of anaphylaxis to contrast agent
Show all 12Show fewer
  • Pregnancy and lactation
  • Life expectancy < 1 year
  • Severe valvular heart disease
  • History of coronary artery bypass grafting (CABG) or planned CABG
  • Fibrinolysis therapy prior to admission
  • Severe asthma

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Min Chul Kim, MD, PhD contact

82-10-4606-2643

kmc3242@hanmail.net

30 sites in 1 country

South Korea30 sites, 30 recruiting
  • Bucheon Sejong Hospital

    Bucheon-si

    Not yet recruiting
  • Gyeongsang National University Changwon Hospital

    Changwon

    Not yet recruiting
  • Samsung Changwon Medical Center

    Changwon

    Not yet recruiting
  • Soon Chun Hyang University Hospital Cheonan

    Cheonan

    Not yet recruiting
  • Chungbuk National University Hospital

    Cheongju-si

    Not yet recruiting
  • Kangwon National University Hospital

    Chuncheon

    Not yet recruiting
  • Daegu Catholic University Medical Center

    Daegu

    Not yet recruiting
  • Keimyung University Dongsan Hospital

    Daegu

    Not yet recruiting
  • Kyungpook National University Hospital

    Daegu

    Not yet recruiting
  • Yeongnam University Medical Center

    Daegu

    Not yet recruiting
  • Chungnam National University Hospital

    Daejeon

    Not yet recruiting
  • Chonnam National University Hospital

    Gwangju

    Recruiting
  • Chosun University Hospital

    Gwangju

    Not yet recruiting
  • Gwangju Veterans Hospital

    Gwangju

    Not yet recruiting
  • Kwangju Christian Hospital

    Gwangju

    Not yet recruiting
  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong

    Not yet recruiting
  • Jeju National University Hospital

    Jeju City

    Not yet recruiting
  • Jeonbuk National University Hospital

    Jeonju

    Not yet recruiting
  • Presbyterian Medical Center

    Jeonju

    Not yet recruiting
  • Gyeongsang National University Hospital

    Jinju

    Not yet recruiting
  • Inje University Busan Paik Hospital

    Pusan

    Not yet recruiting
  • Inje University Haeundae Paik Hospital

    Pusan

    Not yet recruiting
  • Kosin University Gospel Hospital

    Pusan

    Not yet recruiting
  • Pusan National University Hospital

    Pusan

    Not yet recruiting
  • Koera University Guro Hospital

    Seoul

    Not yet recruiting
  • Korea University Anam Hospital

    Seoul

    Not yet recruiting
  • Yonsei University Health System, Gangnam Severance Hospital

    Seoul

    Not yet recruiting
  • St. Carollo General Hospital

    Suncheon

    Not yet recruiting
  • Ajou University Hospital

    Suwon

    Not yet recruiting
  • Pusan National University Yangsan Hospital

    Yangsan

    Not yet recruiting

Other trials in South Korea

About this study

Official title: OPtimal TIming of Staged Complete RevascularizatiON in ST-Segment Elevation Myocardial Infarction With Multivessel Disease: The OPTION-STEMI2 Trial

This prospective, multicenter, open-label, superiority trial will enroll patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. Following successful percutaneous coronary intervention (PCI) of the infarct-related artery (IRA), patients who meet the eligibility criteria will be randomized in a 1:1 ratio to either in-hospital staged complete revascularization with PCI of non-IRA lesions performed on a separate day during hospitalization, at least 48 hours after PCI of the IRA, or out-of-hospital staged complete revascularization with PCI of non-IRA lesions performed after discharge between 15 and 45 days of randomization. In both groups, non-IRA lesions with 50-69% stenosis will be evaluated using FFR.

Read the detailed description
  • Study Objectives: To determine the optimal timing of staged complete revascularization guided by fractional flow reserve (FFR) (in-hospital staged complete revascularization vs. out-of-hospital staged complete revascularization) in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.
  • Study Background: Approximately half of patients with STEMI have multivessel coronary artery disease, which is associated with worse clinical outcomes than single vessel disease. Complete revascularization has become the standard interventional strategy for the management of these patients. Regarding the timing of complete revascularization, two recent randomized clinical trials demonstrated that immediate complete revascularization was non-inferior to staged complete revascularization in patients with STEMI. In this context, the 2023 European guidelines give a class IA recommendation for complete revascularization, either during the index procedure or within 45 days. The 2025 American guidelines recommend immediate complete revascularization with a class IIb recommendation for hemodynamically stable patients with STEMI and low-complex anatomy. However, in these trials, planned staged revascularization in the staged group was performed after hospital discharge rather than during the index admission. In those previous trials, the timing of staged revascularization was median 15 days (IQR 4-28) in the BIOVASC trial and median 37 days (IQR 30-43) in the MULTISTARS AMI trial, and most clinical events in the staged group (mainly due to unplanned revascularization and myocardial infarction) had occurred during the early phase after the index procedure with the possibility of progression of a non-infarct related artery (non-IRA) lesion before the staged procedure. Greater inflammatory status during the acute phase of myocardial infarction might be associated with these findings. The OPTION-STEMI trial, which compared immediate and staged complete revascularization during index hospitalization, failed to demonstrate non-inferiority for the primary endpoint at 1 year (13% in the immediate complete revascularization group and 11% in the staged complete revascularization group; hazard ratio 1.24; 95% confidence interval 0.86-1.79; P for non-inferiority = 0.024). Therefore, it remains unclear whether the treatment effect differs between in-hospital and out-of-hospital staged complete revascularization in patients with STEMI and multivessel disease. The investigators designed a prospective, open-label, multicenter, superiority trial to evaluate the efficacy and safety of in-hospital staged complete revascularization compared with out-of-hospital staged complete revascularization in patients with STEMI and multivessel disease. Non-IRA lesions with 50-69% stenosis will be assessed using FFR, whereas those with ≥ 70% stenosis will undergo revascularization without FFR assessment. The investigators hypothesize that in-hospital staged complete revascularization may mitigate the risk of early progression of non-IRA lesions, compared with out-of-hospital staged complete revascularization, without increasing the procedural risk associated with immediate complete revascularization.
  • Study Hypothesis: In-hospital staged complete revascularization would reduce the risk of the primary composite endpoint (a composite of all-cause death, non-fatal myocardial infarction, or all unplanned revascularization) at 12 months compared with out-of-hospital staged complete revascularization in patients with STEMI and multivessel disease.
Being tested
In-hospital staged complete revascularization, Out-of-hospital staged complete revascularization
Keywords
ST-segment myocardial infarction, Multivessel coronary artery disease, Complete revascularization, Timing
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-hospital staged complete revascularizationProcedure or surgery

    PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 48 hours after PCI of the 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 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

  • Out-of-hospital staged complete revascularizationProcedure or surgery

    PCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. 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 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.

Study groups in NCT07741721
Study groupRoleWhat they receive
In-hospital staged complete revascularizationExperimentalIn the in-hospital staged complete revascularization group, PCI of non-IRA lesions will be performed on a separate day during the index hospitalization, at least 48 hours after PCI of the 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 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Receives: Procedure: In-hospital staged complete revascularization
Out-of-hospital staged complete revascularizationActive comparatorIn the out-of-hospital staged complete revascularization group, PCI of non-IRA lesions will be performed after discharge and between 15 and 45 days of randomization. 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 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion will be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
Receives: Procedure: Out-of-hospital staged complete revascularization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization

    Composite of all-cause death, nonfatal myocardial infarction, or all unplanned

    Measured: At 12 months after randomization

Secondary outcomes (17)
  1. Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization

    Composite of all-cause death, nonfatal myocardial infarction, or all unplanned

    Measured: At 1, 6, 24, 36, 48, and 60 months after randomization

  2. All-cause death

    All-cause death

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  3. Nonfatal myocardial infarction

    Nonfatal myocardial infarction

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  4. All unplanned revascularization

    All unplanned revascularization

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  5. Cardiac death

    Cardiac death

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  6. Non-cardiac death

    Non-cardiac death

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  7. Nonfatal spontaneous myocardial infarction

    Nonfatal spontaneous myocardial infarction

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  8. Nonfatal procedure-related myocardial infarction

    Nonfatal procedure-related myocardial infarction

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  9. Target-lesion revascularization

    Target-lesion revascularization

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  10. Target-vessel revascularization

    Target-vessel revascularization

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  11. Non-target vessel revascularization

    Non-target vessel revascularization

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  12. Hospitalization for unstable angina

    Hospitalization for unstable angina

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  13. Hospitalization for heart failure

    Hospitalization for heart failure

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  14. Stent thrombosis

    Stent thrombosis

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  15. Stroke

    Stroke

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  16. Major bleeding

    Major bleeding

    Measured: At 1, 6, 12, 24, 36, 48, and 60 months after randomization

  17. Contrast-induced nephropathy

    Contrast-induced nephropathy

    Measured: At hospital discharge (up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start21 Aug 2026
  3. Primary completion31 Jul 2031 (estimated)
  4. Study completion31 Jul 2035 (estimated)

Resources

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
1,252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07741721
Sponsor's protocol ID
CNUH-2026-258
Status last verified
Oct 2026
First submitted
26 Jul 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing In-hospital staged complete revascularization and Out-of-hospital staged complete revascularization in people with Myocardial Infarction (MI), run by Chonnam National University Hospital at 30 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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?

Contact Min Chul Kim, MD, PhD (82-10-4606-2643, kmc3242@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause death, nonfatal myocardial infarction, or all unplanned revascularization (time frame: At 12 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in