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

Zibo Central Hospital

Status and phase: Enrolling; Phase 4

Conditions: Adverse Effect of Cardiovascular Medications (Diagnosis)

Treatments: Drug: Evolocumab combined with statins; Drug: Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT05802108

ZiboCH2

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 50-75 years old, gender unlimited;
2. Diagnosed as coronary atherosclerotic heart disease
3. The informed consent for the study has been signed

Exclusion criteria

1. Those who are unable to cooperate with the examination;
2. Poor imaging quality of refractive interstitial opacity;
3. Macular edema or complicated with macular membrane and senile macular degeneration;
4. Have a history of previous fundus surgery;
5. Those with eye diseases that can cause changes in the microvessels of the fundus;
6. Abnormal elevated intraocular pressure;
7. Moderate or above refractive error (≥ ± 3 diopters)
8. People with cognitive impairment, material dependence, and serious mental illness;
9. Those who do not cooperate with follow-up;
10. Those who participate in other clinical trials at the same time

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Experimental Group

Experimental group

Description:

evolocumab combined with statins

Treatment:

Drug: Evolocumab combined with statins

Control Group

Other group

Description:

statins only

Treatment:

Drug: Statin