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

NCT ID: NCT05802108

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Adverse Effect of Cardiovascular Medications (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

evolocumab combined with statins

Group Type EXPERIMENTAL

Evolocumab combined with statins

Intervention Type DRUG

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

Control Group

statins only

Group Type OTHER

Statin

Intervention Type DRUG

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

Interventions

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Evolocumab combined with statins

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

Intervention Type DRUG

Statin

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

Intervention Type DRUG

Other Intervention Names

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drug1 drug2

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zibo Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bo Li

Clinical Professor;Department of Cardiology, Zibo Central Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zibo Central Hospital

Zibo, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinyu Wang, Master

Role: CONTACT

13181933930

Lifen Gao, Master

Role: CONTACT

Facility Contacts

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Xinyu Wang, Master

Role: primary

13181933930

Other Identifiers

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ZiboCH2

Identifier Type: -

Identifier Source: org_study_id

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