Acute Coronary Syndromes (ACS)Phase 4SEsiR-ACSNCT07799779
Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome
A Phase 4 study testing Inclisiran, Atorvastatin or Rosuvastatin and Ezetimibe in people with Acute Coronary Syndromes (ACS), run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This multicenter, randomized, open-label clinical trial will evaluate whether an early intensive lipid-lowering strategy can improve coronary plaque stabilization in patients hospitalized with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Acute Coronary Syndromes (ACS)
- What is being tested?
- Inclisiran, Atorvastatin or Rosuvastatin and Ezetimibe
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2026to Sep 2029
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 to 85 years.
- Hospitalization for acute coronary syndrome (UA, NSTEMI, or STEMI) with planned coronary angiography and PCI, or PCI already performed during the index hospitalization with adequate baseline OCT images obtained during the procedure that meets the study imaging analysis criteria.
- Presence of a target vessel/segment considered by the investigator to be suitable for OCT assessment at baseline and at the 12-month follow-up.
- LDL-C level at screening meeting one of the following criteria according to background lipid-lowering therapy:
- ≥40 mg/dL in patients receiving stable combination therapy with a statin and ezetimibe, defined as no dose change for at least 4 weeks before screening; ii) ≥55 mg/dL in patients receiving high-intensity statin therapy; iii) ≥70 mg/dL in patients receiving low- or moderate-intensity statin therapy; or iv) ≥100 mg/dL in patients not receiving stable statin therapy.
- Provision of voluntary written informed consent after receiving sufficient information regarding the study objectives, procedures, and follow-up plan.
Who cannot join
- Severe hepatic dysfunction, defined as AST or ALT >3 times the upper limit of normal.
- CK >5 times the upper limit of normal or suspected clinically significant myopathy.
- Severe renal impairment, defined as eGFR <30 mL/min/1.73 m².
- Severe hypersensitivity to or contraindication to statins, ezetimibe, or inclisiran.
- Pregnancy, breastfeeding, or plans to become pregnant during the study period.
- Inability to undergo 12-month follow-up coronary angiography and OCT.
- Life expectancy <1 year or, in the investigator's judgment, inappropriate participation in the study because of concerns regarding adherence or safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Chang-Hwan Yoon, +82-031-787-7019, changhwanyoon@gmail.com
About this study
Official title: Statin, Ezetimibe, and Inclisiran for Plaque Regression in Acute Coronary Syndrome: A Randomized Controlled Trial (SEsiR-ACS Trial)
This multicenter, randomized, open-label clinical trial will evaluate whether an early intensive lipid-lowering strategy can improve coronary plaque stabilization in patients hospitalized with acute coronary syndrome. A total of 294 participants will be randomly assigned in a 1:1 ratio to either an early intensive treatment strategy with a high-intensity statin, ezetimibe, and inclisiran, or a guideline-based stepwise lipid-lowering strategy.
Coronary plaque characteristics will be assessed using optical coherence tomography (OCT) at baseline and at 12 months. The primary outcome is the change in minimal fibrous cap thickness from baseline to 12 months. Additional assessments will include other OCT-based plaque characteristics, lipid levels, safety outcomes, and, in a subset of participants, intravascular ultrasound measurements of plaque burden.
- Conditions
- Acute Coronary Syndromes (ACS)
- Being tested
- Inclisiran, Atorvastatin or Rosuvastatin, Ezetimibe
- Keywords
- Inclisiran, Lipid-Lowering Therapy, Optical Coherence Tomography, Fibrous Cap Thickness, Coronary Plaque Stabilization, Atherosclerotic Plaque
- Medical subject headings
- Acute Coronary Syndrome, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Inclisiran sodium 284 mg/1.5 mL will be administered by subcutaneous injection in the early intensive lipid-lowering group. Inclisiran will be initiated during the index hospitalization or as early as feasible thereafter, within 2 weeks, followed by additional doses at 3 months (±2 weeks) and 9 months (±2 weeks).
Atorvastatin or RosuvastatinDrug
High-intensity statin therapy will consist of atorvastatin 40-80 mg orally once daily or rosuvastatin 20 mg orally once daily, or the maximally tolerated dose. High-intensity statin therapy will be initiated or continued during the index hospitalization in both treatment groups.
EzetimibeDrug
Ezetimibe 10 mg will be administered orally once daily. In the early intensive lipid-lowering group, ezetimibe will be initiated during the index hospitalization. In the guideline-based stepwise intensification group, ezetimibe will be added according to follow-up LDL-C levels if the treatment target is not achieved with high-intensity statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Early Intensive Lipid-Lowering Strategy | Experimental | Participants will receive an early intensive lipid-lowering strategy consisting of a high-intensity statin, ezetimibe 10 mg once daily, and inclisiran 284 mg by subcutaneous injection initiated during the index hospitalization or as early as feasible. Inclisiran will be repeated at 3 months and 9 months. Receives: Drug: Inclisiran; Drug: Atorvastatin or Rosuvastatin; Drug: Ezetimibe |
| Guideline-Based Stepwise Intensification Strategy | Active comparator | Participants will receive a guideline-based stepwise lipid-lowering strategy. High-intensity statin therapy will be initiated or continued during the index hospitalization. Ezetimibe will be added according to follow-up LDL-C levels, and a PCSK9 inhibitor may be considered if the LDL-C target remains unmet. Receives: Drug: Atorvastatin or Rosuvastatin; Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minimal Fibrous Cap Thickness
Change from baseline to 12 months in minimal fibrous cap thickness (FCT), measured by optical coherence tomography (OCT) in one prespecified representative matched non-stented coronary plaque or segment per participant.
Measured: Baseline to 12 months
Secondary outcomes (3)
Change in OCT-Derived Lipid Plaque Characteristics
Changes from baseline to 12 months in maximum lipid arc, mean lipid arc, lipid length, lipid index, and the prevalence of thin-cap fibroatheroma (TCFA), assessed by optical coherence tomography (OCT) in matched non-stented coronary plaque segments.
Measured: Baseline to 12 months
Change in Lipid Parameters and LDL-C Target Attainment
Absolute and percentage changes in LDL-C from baseline during follow-up, achievement of the prespecified LDL-C target, defined as LDL-C <40 mg/dL and a reduction of at least 50% from baseline, and changes in non-HDL-C, hsCRP, and, when available, ApoB and Lp(a).
Measured: Baseline to 12 months
Changes in IVUS-Derived Plaque Burden in the IVUS Substudy
Change from baseline to 12 months in percent atheroma volume (PAV), assessed by intravascular ultrasound (IVUS) in matched non-stented coronary segments. Additional IVUS assessments include changes in total atheroma volume (TAV) and plaque burden.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to an early intensive lipid-lowering strategy or a guideline-based stepwise intensification strategy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dotter Co., Ltd., Novartis Korea Ltd., Hanmi Pharmaceutical co., ltd.
- Responsible party
- Principal investigator, Chang-Hwan Yoon, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799779
- Sponsor's protocol ID
- B-2607-1057-003
- Acronym
- SEsiR-ACS
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin, Ezetimibe, and Inclisiran for Plaque Regression in Acute Coronary Syndrome: A Randomized Controlled Trial (SEsiR-ACS Trial)
- ClinicalTrials.gov ID
- NCT07799779
- Acronym / sponsor ID
- SEsiR-ACS / B-2607-1057-003
- Conditions
- Acute Coronary Syndromes (ACS)
- Keywords
- Inclisiran, Lipid-Lowering Therapy, Optical Coherence Tomography, Fibrous Cap Thickness, Coronary Plaque Stabilization, Atherosclerotic Plaque
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Dotter Co., Ltd., Novartis Korea Ltd., Hanmi Pharmaceutical co., ltd.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Sep 2026 (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 multicenter, randomized, open-label clinical trial will evaluate whether an early intensive lipid-lowering strategy can improve coronary plaque stabilization in patients hospitalized with acute coronary syndrome. A total of 294 participants will be randomly assigned in a 1:1 ratio to either an early intensive treatment strategy with a high-intensity statin, ezetimibe, and inclisiran, or a guideline-based stepwise lipid-lowering strategy.
Coronary plaque characteristics will be assessed using optical coherence tomography (OCT) at baseline and at 12 months. The primary outcome is the change in minimal fibrous cap thickness from baseline to 12 months. Additional assessments will include other OCT-based plaque characteristics, lipid levels, safety outcomes, and, in a subset of participants, intravascular ultrasound measurements of plaque burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to an early intensive lipid-lowering strategy or a guideline-based stepwise intensification strategy.
| Arm | Type | Receives |
|---|---|---|
| Early Intensive Lipid-Lowering Strategy | Experimental | Drug: Inclisiran, Drug: Atorvastatin or Rosuvastatin, Drug: EzetimibeParticipants will receive an early intensive lipid-lowering strategy consisting of a high-intensity statin, ezetimibe 10 mg once daily, and inclisiran 284 mg by subcutaneous injection initiated during the index hospitalization or as early as feasible. Inclisiran will be repeated at 3 months and 9 months. |
| Guideline-Based Stepwise Intensification Strategy | Active comparator | Drug: Atorvastatin or Rosuvastatin, Drug: EzetimibeParticipants will receive a guideline-based stepwise lipid-lowering strategy. High-intensity statin therapy will be initiated or continued during the index hospitalization. Ezetimibe will be added according to follow-up LDL-C levels, and a PCSK9 inhibitor may be considered if the LDL-C target remains unmet. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 19 to 85 years.
- Hospitalization for acute coronary syndrome (UA, NSTEMI, or STEMI) with planned coronary angiography and PCI, or PCI already performed during the index hospitalization with adequate baseline OCT images obtained during the procedure that meets the study imaging analysis criteria.
- Presence of a target vessel/segment considered by the investigator to be suitable for OCT assessment at baseline and at the 12-month follow-up.
- LDL-C level at screening meeting one of the following criteria according to background lipid-lowering therapy:
- Provision of voluntary written informed consent after receiving sufficient information regarding the study objectives, procedures, and follow-up plan.
Key exclusion criteria (7 listed)
- Severe hepatic dysfunction, defined as AST or ALT >3 times the upper limit of normal.
- CK >5 times the upper limit of normal or suspected clinically significant myopathy.
- Severe renal impairment, defined as eGFR <30 mL/min/1.73 m².
- Severe hypersensitivity to or contraindication to statins, ezetimibe, or inclisiran.
- Pregnancy, breastfeeding, or plans to become pregnant during the study period.
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 |
|---|---|---|
| InclisiranInclisiran sodium 284 mg/1.5 mL will be administered by subcutaneous injection in the early intensive lipid-lowering group. Inclisiran will be initiated during the index hospitalization or as early as feasible thereafter, within 2 weeks, followed by additional doses at 3 months (±2 weeks) and 9 months (±2 weeks). | Drug | Early Intensive Lipid-Lowering Strategy |
| Atorvastatin or RosuvastatinHigh-intensity statin therapy will consist of atorvastatin 40-80 mg orally once daily or rosuvastatin 20 mg orally once daily, or the maximally tolerated dose. High-intensity statin therapy will be initiated or continued during the index hospitalization in both treatment groups. | Drug | Early Intensive Lipid-Lowering Strategy, Guideline-Based Stepwise Intensification Strategy |
| EzetimibeEzetimibe 10 mg will be administered orally once daily. In the early intensive lipid-lowering group, ezetimibe will be initiated during the index hospitalization. In the guideline-based stepwise intensification group, ezetimibe will be added according to follow-up LDL-C levels if the treatment target is not achieved with high-intensity statin therapy. | Drug | Early Intensive Lipid-Lowering Strategy, Guideline-Based Stepwise Intensification Strategy |
Primary outcome
Change in Minimal Fibrous Cap Thickness
Time frame: Baseline to 12 months
Change from baseline to 12 months in minimal fibrous cap thickness (FCT), measured by optical coherence tomography (OCT) in one prespecified representative matched non-stented coronary plaque or segment per participant.
3 secondary outcomes
Change in OCT-Derived Lipid Plaque Characteristics
Time frame: Baseline to 12 months
Change in Lipid Parameters and LDL-C Target Attainment
Time frame: Baseline to 12 months
Changes in IVUS-Derived Plaque Burden in the IVUS Substudy
Time frame: Baseline to 12 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 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inclisiran, Atorvastatin or Rosuvastatin and Ezetimibe in people with Acute Coronary Syndromes (ACS), run by Seoul National University Bundang Hospital at 1 site 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chang-Hwan Yoon, MD, PhD (+82-031-787-7019, changhwanyoon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Minimal Fibrous Cap Thickness (time frame: Baseline to 12 months). 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 2 Sep 2026.