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Heart attack prevention: should doctors stent dangerous plaques early?
NCT ID NCT07569692
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an early, aggressive approach—using a catheter to open and stent high-risk plaques seen on a CT scan—plus medication is better than medication alone for preventing heart problems. About 2,500 people with coronary artery disease will be randomly assigned to one of the two strategies. The goal is to see which approach reduces deaths, heart attacks, and hospitalizations over three years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- invasive coronary angiography with preventive percutaneous coronary intervention (PCI) plus optimal medical therapy
- What this could lead to
- If successful, this could show that early, preventive stenting of high-risk plaques reduces heart attacks and hospitalizations compared to medication alone.
- What could go wrong
- This is a large trial but has not yet started recruiting. The invasive procedure carries risks like bleeding or vessel damage, and the benefit over medication alone is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged ≥18 years 2. Patients with suspected coronary artery disease (CAD) (e.g., chest pain syndrome or equivalent symptoms) who are evaluated with coronary computed tomography angiography (CCTA) 3. Coronary computed tomography angiography (CCTA) showing: Plaque with at least moderate stenosis in one or more major epicardial coronary arteries; and At least two high-risk plaque (HRP) feature at the site of stenotic lesions, defined as any of the following: * Low-attenuation plaque (LAP) (\<70 Hounsfield units) * Positive remodeling (PR) (remodeling index \>1.2) * Napkin-ring sign (NRS) * Spotty calcification (SC) (\<3 mm in length) 4. Willing and able to provide written informed consent Exclusion Criteria: 1. Acute coronary syndrome (ACS) requiring urgent or emergent invasive evaluation 2. Hemodynamically unstable conditions 3. Significant left main coronary artery disease (≥50% diameter stenosis) 4. Coronary anatomy unsuitable for either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) 5. Left ventricular ejection fraction (LVEF) \<35% → Left ventricular ejection fraction \<35% 6. New York Heart Association (NYHA) class III or IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months 7. Prior coronary artery bypass grafting (CABG) 8. Severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²) or end-stage renal disease on dialysis 9. Contraindication to undergoing coronary computed tomography angiography (CTA) (e.g., allergy to radiographic contrast that cannot be adequately premedicated, any prior anaphylaxis to radiographic contrast, or inability to cooperate with scan acquisition) 10. Contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year 11. Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity 12. Planned cardiac or major noncardiac surgery within the study period 13. Women who are breastfeeding, pregnant, or planning to become pregnant during the course of the study 14. Inability to comply with the study protocol 15. Active participation in another interventional clinical trial involving an unapproved investigational drug or device
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
Seoul, South Korea
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