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

Phase 4

Recruiting

• Conditions: Adverse Effect of Cardiovascular Medications (Diagnosis)
• Interventions: Drug: Evolocumab combined with statins; Drug: Statin

• Registration Number: NCT05802108
• Lead Sponsor: Zibo Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Evolocumab combined with statins	evolocumab combined with statins
Control Group	Statin	statins only

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Zibo Central Hospital; 🇨🇳 Zibo, Shandong, China