NCT06855537

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,190 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Arterial Disease (CAD)
• Vulnerable Coronary Plaques
• Thin-cap fIbroatheroma
• Acute Coronary Syndromes (ACS)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-03-04
• Last updated: 2025-12-02

Locations

1 site across 1 country: China