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Heart attack prevention: should doctors stent dangerous plaques early?

NCT ID NCT07569692

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Asan Medical Center

    Seoul, South Korea

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