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

NCT ID: NCT06855537

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2027-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PCI+OMT

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

Group Type: EXPERIMENTAL

PCI strategy

Intervention Type: PROCEDURE

-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).

OMT strategy

Intervention Type: DRUG

• 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.

OMT

Guideline-recommended optimal medical therapy (including intensive lipid-lowering therapy \[LDL\<1.4mmol/l\] and decreased by 50% compared to the baseline).

Group Type: ACTIVE_COMPARATOR

OMT strategy

Intervention Type: DRUG

• 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.

Interventions

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).

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

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 arc >90°)

Exclusion Criteria

1. Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year

2. Patients with other major illnesses and a life expectancy <2 years

3. Patients scheduled for cardiac surgery or major non-cardiac surgery

4. Women who are breastfeeding, pregnant, or planning pregnancy during the study

5. Patients with severe heart failure (NYHA class III-IV or Killip class III-IV or left ventricular ejection fraction <35%)

6. Patients with estimated glomerular filtration rate <30 mL/(min·1.73 m²)

7. Patients with allergy to contrast agents or DES drugs

1. Patients for whom CABG is the preferred treatment 2. Target lesion is a previously stented lesion 3. Target lesion is a post-bypass lesion 4. Target lesion is a heavily calcified or angulated lesion 5. Target lesion requires dual-stent technique 6. Target lesion is a left main coronary artery lesion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaofan Wu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Boqun SHI

Role: CONTACT

shiboqun@126.com

18801129155

Facility Contacts

BOQUN SHI

Role: primary

shiboqun@126.com

010-84005591

Other Identifiers

2025-04

Identifier Type: -

Identifier Source: org_study_id