Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography in Patients With Premature Coronary Artery Disease: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
First Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Contact Information
Primary
Sen Liu, MD
463387160@qq.com
09914366872
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 396
Treatments
Experimental: PCSK9 inhibitor group
PCSK9 Inhibitors Combined with Moderate-Intensity Statin Therapy
Other: Intensive statin group
Intensive statin therapy
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Xinjiang Medical University

This content was sourced from clinicaltrials.gov