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

NCT06520904 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2024-08-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PCSK9 inhibitor

PCSK9 inhibitors combined with moderate-intensity statin therapy

DRUG

Statin

Intensive statin therapy

Sponsors & Collaborators

  • First Affiliated Hospital of Xinjiang Medical University

    lead OTHER

Principal Investigators

  • Zhenyan Fu, PhD · First Affiliated Hospital of Xinjiang Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06520904 on ClinicalTrials.gov