Stenting silent heart plaques may save lives: major trial underway
NCT ID NCT06855537
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether placing stents in non-blocking but unstable heart plaques, along with intensive medication, reduces heart attacks and other cardiac events better than medication alone. About 2,190 adults with acute coronary syndrome will be randomly assigned to either stenting plus drugs or drugs only. The goal is to find the best way to prevent future heart problems in people with these dangerous plaques.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 2,190 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Sep 2027
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 to 80 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Clinical Inclusion Criteria 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction) 3. Patients willing and able to sign a written informed consent form Angiography, QFR, and OCT Inclusion Criteria 1. Successful completion of angiography, QFR, and OCT examinations 2. Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8) 3. Reference vessel diameter between 2.5-4.0 mm on imaging assessment 4. Lesion length ≤40 mm 5. At least one significant stenosis (diameter reduction \>50%) demonstrated by angiography, with QFR \>0.80 and OCT-defined TCFA (fibrous cap thickness \<65μm, lipid arc \>90°) Exclusion Criteria Clinical Exclusion Criteria 1. Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year 2. Patients with other major illnesses and a life expectancy \<2 years 3. Patients scheduled for cardiac surgery or major non-cardiac surgery 4. Women who are breastfeeding, pregnant, or planning pregnancy during the study 5. Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction \<35%) 6. Patients with estimated glomerular filtration rate \<30 mL/(min·1.73 m²) 7. Patients with allergy to contrast agents or DES drugs 8. Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria 1\. Patients for whom CABG is the preferred treatment 2. Target lesion is a previously stented lesion 3. Target lesion is a post-bypass lesion 4. Target lesion is a heavily calcified or angulated lesion 5. Target lesion requires dual-stent technique 6. Target lesion is a left main coronary artery lesion.
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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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Beijing Anzhen Hospital
RECRUITINGBeijing, Beijing Municipality, 100000, China
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Other studies related to the condition(s) this trial covers.
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