Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques

Official title

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

Overview

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.

Interventions

• Procedure 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).
• Drug 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.

Primary outcome measures

• Target vessel failure [Time frame: From enrollment to the end of treatment at 24 months]

Secondary outcome measures (10)

• 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]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT06855537 · 2025-04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗