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

Sponsor

Zibo Central Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05802108

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect of Cardiovascular Medications (Diagnosis)	Drug: Evolocumab combined with statins Drug: Statin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group evolocumab combined with statins	Drug: Evolocumab combined with statins The experimental group was treated with evolocumab combined with statin for lipid-lowering Other Names: drug1
Other: Control Group statins only	Drug: Statin the control group was treated with statin only for lipid-lowering Other Names: drug2

Arm

Intervention/Treatment

Experimental: Experimental Group

evolocumab combined with statins

Drug: Evolocumab combined with statins

The experimental group was treated with evolocumab combined with statin for lipid-lowering

Other Names:

drug1

Other: Control Group

statins only

Drug: Statin

the control group was treated with statin only for lipid-lowering

Other Names:

drug2

Outcome Measures

Primary Outcome Measures

the main indicator [Up to 12 months]
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).

Secondary Outcome Measures

the secondary indicator [Up to 12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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