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

NCT05802108 | Unknown Phase 4

• 1 other identifier: ZiboCH2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Effect of Cardiovascular Medications (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the secondary indicator

  Up to 12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

evolocumab combined with statins

Drug: Evolocumab combined with statins

Control Group

OTHER

statins only

Drug: Statin

Interventions

Evolocumab combined with statins DRUG

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

Also known as: drug1

Experimental Group

Statin DRUG

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

Also known as: drug2

Control Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zibo Central Hospital: lead

Study Sites (1)

Zibo Central Hospital

Zibo, Shandong, 255000, China

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Central Study Contacts

Xinyu Wang, Master

CONTACT

13181933930; wxysd2021@163.com

Lifen Gao, Master

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor；Department of Cardiology, Zibo Central Hospital

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: April 6, 2023
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

CN (1)