Clinical trial NCT06855537: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
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
colchicine
Fractional Flow Reserve (FFR)
Percutaneous Coronary Angioplasty (PTCA)
Drug Eluting Ballon (DEB)
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 2190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 anti-inflammatory therapy (colchicine 0.5 mg/day) while receiving high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \<1.4 mmol/L). 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 or drug balloons. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.


Eligibility criteria: Inclusion Criteria:

* Aged 18-80, male or non-pregnant female
* Clinical diagnosis of ACS
* Willing and able to provide written informed consent
* At least one significant stenosis (\>50% diameter stenosis) with FFR or QFR \>0.8, meeting the following: OCT-defined thin-cap fibroatheroma (fibrous cap thickness \<65 μm and lipid arc \>90°)
* Reference vessel diameter: 2.5-4.0 mm
* Lesion length ≤ 40 mm

Exclusion Criteria:

* Contraindications to dual antiplatelet therapy or planned discontinuation within one year
* Severe comorbidities with a life expectancy of less than two years
* Planned cardiac or major non-cardiac surgery
* Pregnancy, breastfeeding, or planned pregnancy during the study
* Left ventricular ejection fraction \<35%
* Estimated glomerular filtration rate \<30 ml/min/1.73m²
* Allergy to contrast agents, drug-eluting stents, or DEB drugs
* Participation in other clinical studies
* Preferred treatment is CABG
* Severely calcified or angulated target lesion
* Target lesion requiring dual stent technique
* Left main disease
* Previously stented target lesion
* Target lesion in a graft vessel

Primary outcomes:
measure: Composite endpoint
timeFrame: From enrollment to the end of treatment at 24 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: From enrollment to the end of treatment at 24 months
measure: Target vessel myocardial infarction
timeFrame: From enrollment to the end of treatment at 24 months
measure: Non-target vessel myocardial infarction
timeFrame: From enrollment to the end of treatment at 24 months
measure: Target vessel ischemia-driven revascularization
timeFrame: From enrollment to the end of treatment at 24 months
measure: Non-target vessel ischemia-driven revascularization
timeFrame: From enrollment to the end of treatment at 24 months
measure: Cardiac rehospitalization
timeFrame: From enrollment to the end of treatment at 24 months
measure: Non-cardiac rehospitalization
timeFrame: From enrollment to the end of treatment at 24 months
measure: Stroke
timeFrame: From enrollment to the end of treatment at 24 months
Other outcomes:
Locations:
Study officials:
References: