Coronary Artery DiseasePhase 4NCT06767345

Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization

A Phase 4 study testing Rosuvastatin and Rosuvastatin/ezetimibe in people with Coronary Artery Disease and Atherosclerosis of Coronary Artery, run by Korea University Anam Hospital at 7 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Atherosclerosis of Coronary Artery, Plaque, Atherosclerotic
What is being tested?: Rosuvastatin and Rosuvastatin/ezetimibe
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 410 participants
Where: 7 sitesSouth Korea
Study dates: 12 May 2025to 25 Jun 2028
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult men and women aged 18 years or older.
Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging.
At least one major native coronary artery ("target vessel") meeting all the following criteria for intracoronary imaging immediately following a qualifying PCI procedure:
Angiographic evidence of coronary artery stenosis ≥30% by angiographic visual estimation.
Target vessel is accessible to the imaging catheter and suitable for intracoronary imaging in the proximal 50 mm segment.
Target vessel is not a bypass graft (saphenous vein or arterial) or a bypassed graft vessel.

Show all 9Show fewer

Target vessel has not undergone PCI within the target segment.
Target vessel is not a candidate for PCI at the time of the procedure or for 6 months thereafter (per investigator's judgment).
Patients who have provided written informed consent to participate in the study.

Who cannot join

Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation.
History of coronary artery bypass graft surgery (CABG).
Unstable clinical condition (hemodynamic or electrical instability).
Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation.
Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response) not controlled by medication within 3 months prior to screening.
Active liver disease or liver dysfunction.

Show all 15Show fewer

Severe renal dysfunction (eGFR <30 mL/min/1.73m²)
Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel.
Active infection or major hematologic, metabolic, or endocrine dysfunction as determined by the investigator.
Planned surgery within 12 months.
Currently enrolled in another randomized device study or a drug study involving lipid-lowering therapy.
Estimated life expectancy of less than 2 years.
Women of childbearing potential (under 50 years of age) who:
Had their last menstrual period within the last 12 months.
Have not had tubal ligation, oophorectomy, or hysterectomy.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

South Korea7 sites

Inje University Ilsan Paik Hospital
Goyang, 10380
Korea University Anam Hospital
Seoul, Seoul, 02841
Kyung Hee University Hospital
Seoul, 02447
Hanyang University Hospital
Seoul, 04763
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Chung-Ang University Hospital
Seoul, 06973
Ajou University Hospital
Suwon, 16499

Other trials in South Korea

About this study

Official title: Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization

This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the change in percent atheroma volume (PAV) from baseline to week 52, assessed by grayscale IVUS. Secondary outcomes include changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. Seven hospitals participated in the study. A total of 410 participants were enrolled at six sites; no participants were enrolled at Inje University Ilsan Paik Hospital. Follow-up is ongoing.

Conditions: Coronary Artery Disease, Atherosclerosis of Coronary Artery, Plaque, Atherosclerotic
Being tested: Rosuvastatin, Rosuvastatin/ezetimibe
Medical subject headings: Coronary Artery Disease, Plaque, Atherosclerotic

What participants receive

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

RosuvastatinDrug
Rosuvastatin 20mg once daily
Rosuvastatin/ezetimibeDrug
Rosuvastatin 10mg + Ezetimibe 10mg

Study groups in NCT06767345
Study group	Role	What they receive
High Intensity Statin monotherapy	Active comparator	Rosuvastatin 20 mg once daily Receives: Drug: Rosuvastatin
Combination therapy	Experimental	Rosuvastatin 10mg plus Ezetimibe 10mg fixed dose single-pill combination Receives: Drug: Rosuvastatin/ezetimibe

What is being measured

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

Change in percent atheroma volume (PAV) from baseline to week 52, assessed by gray-scale IVUS
Percent atheroma volume (PAV) is calculated within matched coronary-artery regions of interest as 100 × Σ(EEM CSA - lumen CSA)/Σ(EEM CSA), where EEM CSA is the external elastic membrane cross-sectional area and lumen CSA is the lumen cross-sectional area. Change in PAV between baseline and week 52 is assessed by gray-scale IVUS.
Measured: 52 weeks

Secondary outcomes (16)

Change from baseline to week 52 in total lipid core burden index measured by NIRS (LCBItotal)
Measured: 52 weeks
Changes in NT-pro-BNP from baseline to 52 weeks and associations with plaque progression/regression indices
Measured: 52 weeks
Changes in hsTnT from baseline to 52 weeks and associations with plaque progression/regression indices
Measured: 52 weeks
Changes in hsCRP from baseline to 52 weeks and associations with plaque progression/regression indices
Measured: 52 weeks
Cataract incidence from baseline to 52 weeks
Measured: 52 weeks
Adherence from baseline to week 52 (80% or greater)
Proportion of patients achieving ≥80% adherence to prescribed medication from baseline to week 52
Measured: 52 weeks
Incidence of statin-associated muscle syndrome (SAMS) from baseline to week 52
Measured: 52 weeks
Incidence of new diabetes from baseline to week 52
Measured: 52 weeks
Ischemic Stroke/TIA from Baseline to Week 52
Measured: 52 weeks
Ischemic Coronary Revascularization From Baseline to Week 52
Measured: 52 weeks
Nonfatal myocardial infarction from baseline to week 52
Measured: 52 weeks
Cardiac-related deaths from baseline to week 52
Measured: 52 weeks
All deaths from baseline to week 52
Measured: 52 weeks
Changes in LDL-cholesterol from baseline to 52 weeks and associations with plaque progression/regression indices
LDL-cholesterol levels measured in mg/dL. Blood samples will be collected at baseline and after 52 weeks.
Measured: 52 weeks
Change in maximum LCBI within a 4-mm bin measured by NIRS from baseline to week 52 (maxLCBI4mm)
Measured: 52 weeks
Change in corrected total atherosclerotic plaque volume (NTAV) measured by IVUS from baseline to week 52
Measured: 52 weeks

Timeline

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

12 May 202525 Jun 2028

First posted9 Jan 2025
Study start12 May 2025
Primary completionNov 2027 (estimated)
Study completion25 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 410 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06767345
Sponsor's protocol ID: STOP-PLAQUE
Status last verified: Oct 2026
First submitted: 3 Jan 2025
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Preiss D, Seshasai SR, Welsh P, Murphy SA, Ho JE, Waters DD, DeMicco DA, Barter P, Cannon CP, Sabatine MS, Braunwald E, Kastelein JJ, de Lemos JA, Blazing MA, Pedersen TR, Tikkanen MJ, Sattar N, Ray KK. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.
PubMed 21693744
Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
PubMed 20167359
Davis JW, Weller SC. Intensity of statin therapy and muscle symptoms: a network meta-analysis of 153 000 patients. BMJ Open. 2021 Jun 15;11(6):e043714. doi: 10.1136/bmjopen-2020-043714.
PubMed 34130955
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
PubMed 32227755
Park SJ, Ahn JM, Kang DY, Yun SC, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao HL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang KY, Chae JK, Smyth D, Mintz GS, Stone GW, Park DW; PREVENT Investigators. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. Lancet. 2024 May 4;403(10438):1753-1765. doi: 10.1016/S0140-6736(24)00413-6. Epub 2024 Apr 8.
PubMed 38604213
Kim BK, Hong SJ, Lee YJ, Hong SJ, Yun KH, Hong BK, Heo JH, Rha SW, Cho YH, Lee SJ, Ahn CM, Kim JS, Ko YG, Choi D, Jang Y, Hong MK; RACING investigators. Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial. Lancet. 2022 Jul 30;400(10349):380-390. doi: 10.1016/S0140-6736(22)00916-3. Epub 2022 Jul 18.
PubMed 35863366
Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.
PubMed 35368058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing the Moderate Intensity STatin With Ezetimibe COmbination TheraPy With High Intensity Statin Monotherapy on Coronary PLAQUE Stabilization
ClinicalTrials.gov ID: NCT06767345
Acronym / sponsor ID: STOP-PLAQUE
Conditions: Coronary Artery Disease, Atherosclerosis of Coronary Artery, Plaque, Atherosclerotic
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 410 participants (actual)
Lead sponsor: Korea University Anam HospitalUniversity, hospital or other
Collaborators: Yuhan Corporation, Hanmi Pharmaceutical co., ltd.
Study start: 12 May 2025 (actual)
Primary completion: Nov 2027 (estimated)
Study completion: 25 Jun 2028 (estimated)
First posted: 9 Jan 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Intensity Statin monotherapy	Active comparator	Drug: RosuvastatinRosuvastatin 20 mg once daily
Combination therapy	Experimental	Drug: Rosuvastatin/ezetimibeRosuvastatin 10mg plus Ezetimibe 10mg fixed dose single-pill combination

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Adult men and women aged 18 years or older.
Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging.
At least one major native coronary artery ("target vessel") meeting all the following criteria for intracoronary imaging immediately following a qualifying PCI procedure:
Patients who have provided written informed consent to participate in the study.

Key exclusion criteria (15 listed)

Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation.
History of coronary artery bypass graft surgery (CABG).
Unstable clinical condition (hemodynamic or electrical instability).
Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation.
Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response) not controlled by medication within 3 months prior to screening.

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
RosuvastatinRosuvastatin 20mg once daily	Drug	High Intensity Statin monotherapy
Rosuvastatin/ezetimibeRosuvastatin 10mg + Ezetimibe 10mg	Drug	Combination therapy

Primary outcome

Change in percent atheroma volume (PAV) from baseline to week 52, assessed by gray-scale IVUS
Time frame: 52 weeks
Percent atheroma volume (PAV) is calculated within matched coronary-artery regions of interest as 100 × Σ(EEM CSA - lumen CSA)/Σ(EEM CSA), where EEM CSA is the external elastic membrane cross-sectional area and lumen CSA is the lumen cross-sectional area. Change in PAV between baseline and week 52 is assessed by gray-scale IVUS.

16 secondary outcomes

Change from baseline to week 52 in total lipid core burden index measured by NIRS (LCBItotal)
Time frame: 52 weeks
Changes in NT-pro-BNP from baseline to 52 weeks and associations with plaque progression/regression indices
Time frame: 52 weeks
Changes in hsTnT from baseline to 52 weeks and associations with plaque progression/regression indices
Time frame: 52 weeks
Changes in hsCRP from baseline to 52 weeks and associations with plaque progression/regression indices
Time frame: 52 weeks
Cataract incidence from baseline to 52 weeks
Time frame: 52 weeks
Adherence from baseline to week 52 (80% or greater)
Time frame: 52 weeks
Incidence of statin-associated muscle syndrome (SAMS) from baseline to week 52
Time frame: 52 weeks
Incidence of new diabetes from baseline to week 52
Time frame: 52 weeks
Ischemic Stroke/TIA from Baseline to Week 52
Time frame: 52 weeks
Ischemic Coronary Revascularization From Baseline to Week 52
Time frame: 52 weeks
Nonfatal myocardial infarction from baseline to week 52
Time frame: 52 weeks
Cardiac-related deaths from baseline to week 52
Time frame: 52 weeks
All deaths from baseline to week 52
Time frame: 52 weeks
Changes in LDL-cholesterol from baseline to 52 weeks and associations with plaque progression/regression indices
Time frame: 52 weeks
Change in maximum LCBI within a 4-mm bin measured by NIRS from baseline to week 52 (maxLCBI4mm)
Time frame: 52 weeks
Change in corrected total atherosclerotic plaque volume (NTAV) measured by IVUS from baseline to week 52
Time frame: 52 weeks

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 26 Oct 2026.
Background: PubMed 21693744Preiss D, Seshasai SR, Welsh P, Murphy SA, Ho JE, Waters DD, DeMicco DA, Barter P, Cannon CP, Sabatine MS, Braunwald E, Kastelein JJ, de Lemos JA, Blazing MA, Pedersen TR, Tikkanen MJ, Sattar N, Ray KK. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.
Background: PubMed 20167359Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
Background: PubMed 34130955Davis JW, Weller SC. Intensity of statin therapy and muscle symptoms: a network meta-analysis of 153 000 patients. BMJ Open. 2021 Jun 15;11(6):e043714. doi: 10.1136/bmjopen-2020-043714.
Background: PubMed 32227755Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
Background: PubMed 38604213Park SJ, Ahn JM, Kang DY, Yun SC, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao HL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang KY, Chae JK, Smyth D, Mintz GS, Stone GW, Park DW; PREVENT Investigators. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. Lancet. 2024 May 4;403(10438):1753-1765. doi: 10.1016/S0140-6736(24)00413-6. Epub 2024 Apr 8.
Background: PubMed 35863366Kim BK, Hong SJ, Lee YJ, Hong SJ, Yun KH, Hong BK, Heo JH, Rha SW, Cho YH, Lee SJ, Ahn CM, Kim JS, Ko YG, Choi D, Jang Y, Hong MK; RACING investigators. Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial. Lancet. 2022 Jul 30;400(10349):380-390. doi: 10.1016/S0140-6736(22)00916-3. Epub 2022 Jul 18.
Background: PubMed 35368058Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.
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.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 15 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 26 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 7 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.

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?

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?

Change in percent atheroma volume (PAV) from baseline to week 52, assessed by gray-scale IVUS (time frame: 52 weeks). 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 NCT06767345, which also lists 7 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 26 Oct 2026.