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Real-world study of the efficacy, safety, and cardiovascular benefits of initial combined lipid-lowering therapy in outpatients with very high-risk ASCVD

Real-world study of the efficacy, safety, and cardiovascular benefits of initial combined lipid-lowering therapy in outpatients with very high-risk ASCVD

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045091
Enrollment
Unknown
Registered
2021-04-06
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-11-08

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

Experimental group:Atorvastatin (Sumaitone: 20mg Po QN) combined with iluzumab injection (Rebenon: 420 mg sc once a month)
Control group:Atorvastatin (sumetone: 20mg po QN) combined with ezetimibe (episol: 10 mg po QD)

Sponsors

Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age from 18 to 85 years old, regardless of gender; 2.According to the 2019 ESC/EAS blood lipid guidelines, the following "very high-risk ASCVD" patients (may be accompanied by moderately elevated triglycerides: TG range: 2.3-5.6 mmol/L, that is, 200-500 mg/dL): (1)Carotid artery ultrasound examination revealed significant plaque; (2)Diabetes patients with target organ damage and >=3 major risk factors [According to the 2019 China Cholesterol Education Program Lipid-lowering therapy to reduce cardiovascular events, experts recommend that risk factors include: age (male >=45 years old or female >=55 years old) ), smoking, low-high-density lipoprotein cholesterol, body mass index >=28kg/m^2, family history of early-onset ischemic cardiovascular disease].

Exclusion criteria

Exclusion criteria: 1.Those who are intolerant of statin drugs, ezetimibe and iloyuumab drugs; 2.Those who have used lipid-lowering drugs 24 weeks ago; 3.Pregnant and lactating women; 4.Mental disorders, unable to express their wishes clearly; 5.Those who are unwilling to receive the initial combined lipid-lowering therapy; 6.Those who are unwilling to cooperate, and those who are deemed unsuitable by the doctor, etc.

Design outcomes

Primary

MeasureTime frame
Low density lipoprotein cholesterin;Lipoprotein a;Carotid palque(18F-NaF PET CT);

Secondary

MeasureTime frame
Total cholesterol;Triglyceride;High density lipoprotein cholesterol;Non high density lipoprotein cholesterol;

Countries

China

Contacts

Public ContactXia Ke

Xiangya Hospital

zyakk@163.com+86 13908483367

Outcome results

None listed

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