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New treatment option for Coronary Artery Disease
Official title Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
ClinicalTrials.gov ID: NCT06767345
What this study is testing
What is statins, ezetimibe?
statins, ezetimibe is an investigational medicine, given as an once-daily, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult men and women over the age of 18 years.
- 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...
- 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.
You likely can't join if
- 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...
- Active liver disease or liver dysfunction.
See the full eligibility criteria
- Adult men and women over the age of 18 years.
- 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 (aortic or arterial) or a bypassed graft vessel.
- 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.
- 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.
- 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 investigational device or drug study.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.