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Exploration of lipid-lowering treatment scheme of evolocumab: a randomized, single blind, placebo-controlled prospective clinical study

Exploration of lipid-lowering treatment scheme of evolocumab: a randomized, single blind, placebo-controlled prospective clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057217
Enrollment
Unknown
Registered
2022-03-04
Start date
2022-03-04
Completion date
Unknown
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic cardiovascular disease (ASCVD)

Interventions

Group A:Oral statins combined with ilozumab administered subcutaneously
Group B:An oral placebo combined with a subcutaneous injection of iloxumab

Sponsors

The Second Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years shall sign the informed consent; 2. Patients diagnosed with atherosclerotic cardiovascular disease (ASCVD); 3. Blood lipid still fails to reach the standard after regular use of statins for lipid-lowering treatment.

Exclusion criteria

Exclusion criteria: 1. LDL-C was still not up to standard after ilozumab combined with statins for lipid-lowering treatment; 2. The LDL-C level could not reach the standard after iloxumumab monotherapy; 3. Recurrent myocardial infarction + previous vascular events in the past 2 years; 4. ACS+ multi-vessel disease; 5. ACS+ multivessel disease; 6. ACS+ familial hypercholesterolemia; 7. ACS+ diabetes + at least one extra risk factor (including high-sensitivity C-reactive egg white >=3 mg/L and/or chronic renal disease eGFR 50 mg/dL); 8. Patients who have received prior treatment with ilozumab or any other experimental PCSK9 inhibitor; 9. Active liver disease or liver dysfunction.

Design outcomes

Primary

MeasureTime frame
Blood fat;Carotid plaque;

Countries

China

Contacts

Public ContactZhang Lihua

The Second Affiliated Hospital of Zhengzhou University

zlhxh@126.com+86 13607692769

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026