Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography

NCT ID: NCT06520904

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-12-31

Brief Summary

The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.

Detailed Description

Following initial percutaneous coronary intervention (PCI) for culprit lesions in patients with early-onset coronary artery disease (CAD) and ≥2 additional lesions meeting baseline lipid criteria, optical coherence tomography (OCT) was employed to evaluate non-culprit lesion sites for detailed characterization of plaque features including calcification, fibrosis, fibrolipid deposition, necrosis, minimum fibrous cap thickness (mFCT), and maximum lipid arc (MLA). Subsequently, patients were randomized in a 1:1 ratio to receive either intensive statin therapy alone or a combination of PCSK9 inhibitor with moderate-intensity statin therapy, using a random number allocation method. After 1 year of treatment and follow-up, OCT reassessment of non-culprit vessel critical lesions was conducted, documenting plaque characteristics such as calcification, fibrosis, fibrolipid content, necrosis, as well as stability parameters like mFCT and MLA at lesion sites. OCT findings were compared longitudinally within each treatment group and between groups receiving PCSK9 inhibitor combined with statin therapy versus intensive statin therapy alone. Baseline clinical profiles, biochemical markers, imaging findings, and incidence of adverse cardiovascular events during the follow-up period were also meticulously recorded for all enrolled early-onset CAD patients.

Conditions

Coronary Artery Disease; Optical Coherence Tomography

Study Design

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

Study Groups

PCSK9 inhibitor group

PCSK9 Inhibitors Combined with Moderate-Intensity Statin Therapy

Group Type: EXPERIMENTAL

PCSK9 inhibitor

Intervention Type: DRUG

PCSK9 inhibitors combined with moderate-intensity statin therapy

Intensive statin group

Intensive statin therapy

Group Type: OTHER

Statin

Intervention Type: DRUG

Intensive statin therapy

Interventions

PCSK9 inhibitor

PCSK9 inhibitors combined with moderate-intensity statin therapy

Intervention Type: DRUG

Statin

Intensive statin therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men aged 18-55 years and women aged 18-65 years;
• CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level);
• LDL-C >3.4 mmol/L without regular statin therapy or LDL-C >1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.

Exclusion Criteria

• Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
• Prior use of PCSK9 inhibitors;
• Prior history of hemorrhagic stroke;
• Prior coronary artery bypass grafting or coronary intervention;
• Inability to perform OCT imaging or unclear imaging;
• Severe renal insufficiency (creatinine clearance < 30 mL/min);
• Severe hepatic dysfunction;
• Baseline triglycerides > 5.6 mmol/L;
• Pregnant or lactating women;
• Life expectancy not exceeding 1 year;
• In the judgment of the investigator, unsuitable for this study for any reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhenyan Fu, PHD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenyan Fu, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Locations

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sen Liu, MD

Role: CONTACT

463387160@qq.com

09914366872 ext. +86

Facility Contacts

Sen Liu, MD

Role: primary

463387160@qq.com

09914366872 ext. +86

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Other Identifiers

EPCAP-OCT

Identifier Type: -

Identifier Source: org_study_id