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 w
| Condition(s) | Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques, Thin-cap fIbroatheroma, Acute Coronary Syndromes (ACS) |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 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 base |
| Who can participate | 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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Beijing Anzhen Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2025-11-03 |
| NCT ID | NCT06855537 |
| Official listing | https://clinicaltrials.gov/study/NCT06855537 |