Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy

Study Overview
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Brief Summary
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In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. The specific indicators included retinal microvessel diameter, macular area，optic disc vascular density and FAZ(Foveal Avascular Zone)area, etc., to clarify the effect of evolocumab on retinal microvessels after intensive lipid-lowering therapy.

Official Title
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Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy

Conditions
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Adverse Effect of Cardiovascular Medications (Diagnosis)

Intervention / Treatment
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* Drug: Evolocumab combined with statins
* Drug: Statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-75 years old, gender unlimited; Diagnosed as coronary atherosclerotic heart disease The informed consent for the study has been signed Exclusion Criteria: Those who are unable to cooperate with the examination; Poor imaging quality of refractive interstitial opacity; Macular edema or complicated with macular membrane and senile macular degeneration; Have a history of previous fundus surgery; Those with eye diseases that can cause changes in the microvessels of the fundus; Abnormal elevated intraocular pressure; Moderate or above refractive error (≥ ± 3 diopters) People with cognitive impairment, material dependence, and serious mental illness; Those who do not cooperate with follow-up; Those who participate in other clinical trials at the same time

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>evolocumab combined with statins | Drug: Evolocumab combined with statins<br>* The experimental group was treated with evolocumab combined with statin for lipid-lowering<br>* Other names: drug1;|
| Other: Control Group<br>statins only | Drug: Statin<br>* the control group was treated with statin only for lipid-lowering<br>* Other names: drug2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the main indicator | Video disc area (4.5 × 4.5 mm2) of the radial capillary network (RPC) around the nipple and the macular area (6 × 6 mm2), superficial retinal vascular plexus (SCP) and deep retinal vascular plexus (DCP). | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the secondary indicator | The thickness of the retinal nerve fiber layer (RNFL) near the optic disc, the thickness of the retinal ganglion cell layer in the macular region, the area of the avascular zone (FAZ) in the fovea, the changes of blood lipids, and the changes of the diameter of the retinal branch veins near the optic disc | Up to 12 months |