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

Launched by FIRST AFFILIATED HOSPITAL OF XINJIANG MEDICAL UNIVERSITY · Jul 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a type of medication called PCSK9 inhibitors affects heart health, specifically focusing on heart plaques in patients with coronary artery disease (CAD). These plaques can block blood flow to the heart, and understanding if PCSK9 inhibitors can help stabilize or improve them is important. The study involves patients who are younger and have been diagnosed with CAD, and it will use a special imaging technique called optical coherence tomography (OCT) to see any changes in the plaques.

To be eligible for this study, participants need to be men aged 18-55 or women aged 18-65 who have CAD with significant blockages in at least two blood vessels. They should also have high levels of LDL cholesterol, which is often called "bad" cholesterol. If you join the trial, you will receive the PCSK9 inhibitors and undergo OCT imaging to monitor how your heart plaques respond to the treatment. This study is important because it could provide insights into new ways to treat and manage coronary artery disease, especially in younger patients.

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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.