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NCT Number: NCT06855537

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?

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.

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Key information

Conditions

Coronary Arterial Disease (CAD) Acute Coronary Syndrome Acute Coronary Syndromes (ACS) Cardiovascular Diseases Heart Diseases Myocardial Ischemia Thin-cap fIbroatheroma Vascular Diseases Vulnerable Coronary Plaques

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

BOQUN SHI

CONTACT

[email protected]

010-84005591

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Successful completion of angiography, QFR, and OCT examinations
  • Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8)
  • Reference vessel diameter between 2.5-4.0 mm on imaging assessment
  • Lesion length ≤40 mm
  • 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

  • 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)
  • Patients with allergy to contrast agents or DES drugs
  • Patients currently enrolled in other clinical studies Angiographic Exclusion Criteria
  • 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.

Treatment and study plan

PCI strategy

Procedure

-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 strategy

Drug
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Death

    Time frame: From enrollment to the end of treatment at 24 months

    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.

  2. Myocardial infarction

    Time frame: From enrollment to the end of treatment at 24 months

    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.

  3. Revascularization

    Time frame: From enrollment to the end of treatment at 24 months

    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

  4. Hospitalization for any cause

    Time frame: From enrollment to the end of treatment at 24 months

    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.

  5. Intrastent thrombus

    Time frame: From enrollment to the end of treatment at 24 months

    Intrastent thrombus: Defined according to the explicit or probable criteria established by the Academic Research Consortium (ARC).

  6. Stroke

    Time frame: From enrollment to the end of treatment at 24 months

    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.

  7. Bleeding events

    Time frame: From enrollment to the end of treatment at 24 months

    Bleeding events: Events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria. Severe bleeding is defined as BARC grades 3-5.

  8. Major adverse cardiovascular events

    Time frame: From enrollment to the end of treatment at 24 months

    Major adverse cardiovascular events: cardiovascular death, non-fatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina.

  9. Patient-oriented outcomes

    Time frame: From enrollment to the end of treatment at 24 months

    Patient-oriented outcomes: A composite endpoint comprising death from any cause, myocardial infarction, or repeat revascularization.

  10. Angina symptoms

    Time frame: From enrollment to the end of treatment at 24 months

    Angina symptoms: Based on the Seattle Angina Scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Boqun SHI

CONTACT

[email protected]

18801129155

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Randomized Controlled Study on the Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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