Coronary Arterial Disease (CAD)Phase 4NCT06855537
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
A Phase 4 study testing PCI strategy and OMT strategy in people with Coronary Arterial Disease (CAD) and Vulnerable Coronary Plaques, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is: Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy? Researchers… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Thin-cap fIbroatheroma
- What is being tested?
- PCI strategy and OMT strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,190 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2025to 1 Sep 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
- Patients with other major illnesses and a life expectancy <2 years
- Patients scheduled for cardiac surgery or major non-cardiac surgery
- Women who are breastfeeding, pregnant, or planning pregnancy during the study
- Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction <35%)
- Patients with estimated glomerular filtration rate <30 mL/(min·1.73 m²)
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- Patients with allergy to contrast agents or DES drugs
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100000
BOQUN SHI, 010-84005591, shiboqun@126.com
About this study
Official title: Randomized Controlled Study on the Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is:
Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy?
Read more
Researchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group).
Participants will:
Assigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol <1.4 mmol/L and decreased by 50% compared to the baseline). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension.
Assigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.
- Conditions
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Thin-cap fIbroatheroma, Acute Coronary Syndromes (ACS)
- Being tested
- PCI strategy, OMT strategy
- Keywords
- Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Randomized Controlled Trial (RCT), Optimal Medical Therapy, Drug Eluting Stent (DES), Quantitative Flow Ratio (QFR), Acute Coronary Syndromes (ACS), Vulnerable Coronary Plaques
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI strategyProcedure or surgery
-In the intervention group, vulnerable plaque lesions (quantitative flow ratio, QFR >0.8) to be treated at the operator's discretion using second-generation drug eluting stent (DES).
OMT strategyDrug
- Lifestyle modifications and intensive medical therapy (based on current guideline-directed secondary prevention).
- Both groups to receive statin or other therapies to achieve LDL-C <1.4 mmol/L and decrease by 50% compared to the baseline.
- Lifestyle and risk factor management to include smoking cessation, nutritional optimization, physical activity, adherence to prescribed medications, and control of diabetes and hypertension.
| Study group | Role | What they receive |
|---|---|---|
| PCI+OMT | Experimental | PCI plus guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy [LDL<1.4mmol/l and decreased by 50% compared to the baseline]). Receives: Procedure: PCI strategy; Drug: OMT strategy |
| OMT | Active comparator | Guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy [LDL<1.4mmol/l] and decreased by 50% compared to the baseline). Receives: Drug: OMT strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure
Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization, and hospitalization for unstable or worsening angina.
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (10)
Death
Including all-cause mortality, cardiovascular mortality, or non-cardiovascular mortality. All-cause mortality: Deaths classified as cardiac, non-cardiac, or of unknown cause. Cardiovascular mortality: Deaths due to direct cardiac causes (e.g., acute myocardial infarction, congestive heart failure, fatal arrhythmia), sudden cardiac death, and all deaths related to surgery or concomitant treatment. Non-cardiovascular mortality: Deaths definitively attributed to non-cardiac disease.
Measured: From enrollment to the end of treatment at 24 months
Myocardial infarction
Including spontaneous myocardial infarction, perioperative myocardial infarction, and target vessel or non-target vessel-related myocardial infarction. Myocardial infarction: Based on the Fourth Edition Global Myocardial Infarction Definition Criteria. Spontaneous myocardial infarction: Includes types 1, 2, 4b, and 4c in the Fourth Edition Global Myocardial Infarction Classification. Perioperative myocardial infarction: Includes types 4a and 5 in the fourth edition of the Global Myocardial Infarction Classification. Target vessel myocardial infarction: Refers to ischemic necrosis of myocardial tissue supplied by the target vessel where a stent was implanted, resulting from in-stent thrombosis, restenosis, or other causes following coronary intervention. Non-target vessel myocardial infarction: Refers to ischemic necrosis in the corresponding myocardial region following coronary intervention due to obstruction or spasm in a non-target vessel.
Measured: From enrollment to the end of treatment at 24 months
Revascularization
Revascularization refers to repeat percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). All revascularization events will be classified as either ischemia-driven or non-ischemia-driven. A revascularization will be considered ischemia-driven if, upon coronary angiography, the re-implanted coronary segment exhibits ≥50% diameter stenosis and meets any one of the following ischemia-related criteria: a) History of chest pain (potentially related to the target vessel) b) Electrocardiographic changes at rest or objective evidence of ischemia during exercise testing or equivalent conditions (potentially related to the target vessel) c) Abnormal results from any invasive functional diagnostic test such as FFR
Measured: From enrollment to the end of treatment at 24 months
Hospitalization for any cause
Hospitalization for any cause: Refers to a patient being admitted to an inpatient ward or emergency department with a minimum hospital stay of 24 hours. Additionally, the reason for readmission will be classified based on any cause, cardiac cause, or non-cardiac cause.
Measured: From enrollment to the end of treatment at 24 months
Intrastent thrombus
Intrastent thrombus: Defined according to the explicit or probable criteria established by the Academic Research Consortium (ARC).
Measured: From enrollment to the end of treatment at 24 months
Stroke
Stroke: Refers to the sudden onset of neurological dysfunction caused by impaired cerebral blood flow or intracerebral hemorrhage, in the absence of obvious non-vascular causes such as trauma, tumors, or infections.
Measured: From enrollment to the end of treatment at 24 months
Bleeding events
Bleeding events: Events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria. Severe bleeding is defined as BARC grades 3-5.
Measured: From enrollment to the end of treatment at 24 months
Major adverse cardiovascular events
Major adverse cardiovascular events: cardiovascular death, non-fatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina.
Measured: From enrollment to the end of treatment at 24 months
Patient-oriented outcomes
Patient-oriented outcomes: A composite endpoint comprising death from any cause, myocardial infarction, or repeat revascularization.
Measured: From enrollment to the end of treatment at 24 months
Angina symptoms
Angina symptoms: Based on the Seattle Angina Scale.
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start3 Nov 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofan Wu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855537
- Sponsor's protocol ID
- 2025-04
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables,figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on the Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
- ClinicalTrials.gov ID
- NCT06855537
- Acronym / sponsor ID
- 2025-04
- Conditions
- Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Thin-cap fIbroatheroma, Acute Coronary Syndromes (ACS)
- Keywords
- Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Randomized Controlled Trial (RCT), Optimal Medical Therapy, Drug Eluting Stent (DES), Quantitative Flow Ratio (QFR), Acute Coronary Syndromes (ACS), Vulnerable Coronary Plaques
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,190 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Mar 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.
The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is:
Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy?
Researchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group).
Participants will:
Assigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol <1.4 mmol/L and decreased by 50% compared to the baseline). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension.
Assigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI+OMT | Experimental | Procedure: PCI strategy, Drug: OMT strategyPCI plus guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy [LDL<1.4mmol/l and decreased by 50% compared to the baseline]). |
| OMT | Active comparator | Drug: OMT strategyGuideline-recommended optimal medical therapy (including intensive lipid-lowering therapy [LDL<1.4mmol/l] and decreased by 50% compared to the baseline). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
- Patients with other major illnesses and a life expectancy <2 years
- Patients scheduled for cardiac surgery or major non-cardiac surgery
- Women who are breastfeeding, pregnant, or planning pregnancy during the study
- Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction <35%)
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 |
|---|---|---|
| PCI strategy-In the intervention group, vulnerable plaque lesions (quantitative flow ratio, QFR >0.8) to be treated at the operator's discretion using second-generation drug eluting stent (DES). | Procedure or surgery | PCI+OMT |
| OMT strategy* Lifestyle modifications and intensive medical therapy (based on current guideline-directed secondary prevention). * Both groups to receive statin or other therapies to achieve LDL-C <1.4 mmol/L and decrease by 50% compared to the baseline. * Lifestyle and risk factor management to include smoking cessation, nutritional optimization, physical activity, adherence to prescribed medications, and control of diabetes and hypertension. | Drug | OMT, PCI+OMT |
Primary outcome
Target vessel failure
Time frame: From enrollment to the end of treatment at 24 months
Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization, and hospitalization for unstable or worsening angina.
10 secondary outcomes
Death
Time frame: From enrollment to the end of treatment at 24 months
Myocardial infarction
Time frame: From enrollment to the end of treatment at 24 months
Revascularization
Time frame: From enrollment to the end of treatment at 24 months
Hospitalization for any cause
Time frame: From enrollment to the end of treatment at 24 months
Intrastent thrombus
Time frame: From enrollment to the end of treatment at 24 months
Stroke
Time frame: From enrollment to the end of treatment at 24 months
Bleeding events
Time frame: From enrollment to the end of treatment at 24 months
Major adverse cardiovascular events
Time frame: From enrollment to the end of treatment at 24 months
Patient-oriented outcomes
Time frame: From enrollment to the end of treatment at 24 months
Angina symptoms
Time frame: From enrollment to the end of treatment at 24 months
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables,figures, and appendices).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCI strategy and OMT strategy in people with Coronary Arterial Disease (CAD) and Vulnerable Coronary Plaques, run by Beijing Anzhen Hospital at 1 site in China.
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 0 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 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 1 site in China. 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?
Contact Boqun SHI (18801129155, shiboqun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (time frame: From enrollment to the end of treatment at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.