Effects of PCSK9 inhibitors on heart artery plaque

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: 463387160@qq.com
• Phone: 09914366872

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.