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

Sponsor
Zibo Central Hospital
Study ID
NCT05802108
Phase
PHASE4
Status
Unknown

Conditions

  • Adverse Effect of Cardiovascular Medications (Diagnosis)

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab combined with statins — DRUG
    The experimental group was treated with evolocumab combined with statin for lipid-lowering
  • Statin — DRUG
    the control group was treated with statin only for lipid-lowering

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Mar 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    evolocumab combined with statins
  • Other: Control Group
    statins only

Primary Outcome Measure

the main indicator [ Time Frame: Up to 12 months ]

Central Contacts