Effects of PCSK9 inhibitors on heart artery plaque

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

This study tests if adding PCSK9 inhibitors to statin therapy can improve heart artery plaque in Asian patients with early-onset coronary artery disease.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 396 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Xinjiang Medical University (Academic / other)
• Locations: 1 site (Ürümqi, Xinjiang)
• Trial ID: NCT06520904 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates how PCSK9 inhibitors affect coronary atherosclerotic plaques in patients with early-onset coronary artery disease (CAD), using optical coherence tomography (OCT) for detailed imaging. After initial treatment for critical lesions, patients are randomized to receive either intensive statin therapy alone or a combination of PCSK9 inhibitors with moderate-intensity statin therapy. The study aims to assess changes in plaque characteristics and stability over one year of treatment. It is conducted at a single center in Xinjiang, China, focusing on Asian patients.

Who should consider this trial

Good fit: Ideal candidates are men aged 18-55 and women aged 18-65 with early-onset CAD and specific lipid levels.

Not a fit: Patients with known allergies to PCSK9 inhibitors or statins, or those with severe renal or hepatic dysfunction, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for stabilizing coronary plaques in patients with early-onset CAD.

How similar studies have performed: While there is limited research specifically on PCSK9 inhibitors and plaque stabilization in early-onset CAD, similar studies have shown promise in lipid-lowering therapies.

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.

Where this trial is running

Ürümqi, Xinjiang

• First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)

Study contacts

• Principal investigator: Zhenyan Fu, PhD — First Affiliated Hospital of Xinjiang Medical University
• Study coordinator: Sen Liu, MD

Conditions Coronary Artery Disease; Optical Coherence Tomography; Lipid-lowering Therapy; PCSK9