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

NCT06855537 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2190

Last updated 2025-12-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06855537 on ClinicalTrials.gov