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Clinical efficacy of PCSK9 inhibitor Aliciumab in the treatment of hypercholesterolemia complicated with carotid atherosclerosis

Clinical efficacy of PCSK9 inhibitor Aliciumab in the treatment of hypercholesterolemia complicated with carotid atherosclerosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058389
Enrollment
Unknown
Registered
2022-04-08
Start date
2022-03-25
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

PCSK9 inhibitor aliciumab in the treatment of hypercholesterolemia with carotid atherosclerosis

Interventions

2:Statins + ezetimumab
3:Statins + aliciumab
4:statins + ezetimumab + aliciumab

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-89 years; 2. The diagnostic standard of patients with dyslipidemia is higher than the blood lipid level stratification standard and the target value determined by the risk stratification of dyslipidemia in the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese Adults (2016 Revision), that is, TC = 5.2mmol/L and/or LDL-C = 3.4mmol/L; 3. Carotid atherosclerotic plaque formation was confirmed by carotid artery Doppler ultrasound; 4. The patients who voluntarily participate, are hospitalized and have conditional follow-up shall sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Secondary hyperlipidemia caused by thyroid dysfunction, nephrotic syndrome and familial hyperlipidemia; 2. Serious cardiac insufficiency: left ventricular ejection fraction (EF) = 30%; 3. Pregnant women; 4. Liver function is abnormal, and AST and ALT are 3 times or more higher than the upper limit of normal reference; 5. Those with connective tissue disease, rheumatic immune system disease, rhabdomyolysis, blood system disease and malignant tumor, and those with other types of intracranial lesions; 6. Have a history of major surgery and trauma, and suffer from acute and chronic infection and fever within one month; 7. Those who took statins and ezetimibe one month before admission, and those who had clear contraindications to the two drugs or had a history of allergy; 8. There is renal insufficiency, and the creatinine (Scr) is higher than the normal reference value.

Design outcomes

Primary

MeasureTime frame
Indexes of liver and kidney function;Creatine kinase;Blood lipid indicators;Hematological indicators;

Countries

China

Contacts

Public ContactXu Yunhong

The Third Affiliated Hospital of Guangzhou Medical University

xuyunhong553@163.com+86 13697479017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 29, 2026