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

Phase 4

Not yet recruiting

• Conditions: Coronary Arterial Disease (CAD); Vulnerable Coronary Plaques; Thin-cap fIbroatheroma; Acute Coronary Syndromes (ACS)
• Interventions: Procedure: PCI strategy; Drug: OMT strategy

• Registration Number: NCT06855537
• Lead Sponsor: Beijing Anzhen Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-04
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-23
• Study Start: 2025-10-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2190

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI+OMT	PCI strategy	PCI plus guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l and decreased by 50% compared to the baseline\]).
PCI+OMT	OMT strategy	PCI plus guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l and decreased by 50% compared to the baseline\]).
OMT	OMT strategy	Guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l\] and decreased by 50% compared to the baseline).

Primary Outcome Measures

Name	Time	Method
Target vessel failure	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 Outcome Measures

Name	Time	Method
Death	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.
Myocardial infarction	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.
Revascularization	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
Hospitalization for any cause	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.
Intrastent thrombus	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).
Stroke	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.
Bleeding events	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.
Major adverse cardiovascular events	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.
Patient-oriented outcomes	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.
Angina symptoms	From enrollment to the end of treatment at 24 months	Angina symptoms: Based on the Seattle Angina Scale.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China