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Real-World Effectiveness of Adding Haibomeib on Top of Statin Therapy for Very High-Risk ASCVD

Real-World Effectiveness of Adding Hybutimibe Tablets on Top of Statin Therapy for Very High-Risk ASCVD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119419
Enrollment
Unknown
Registered
2026-02-26
Start date
2026-02-26
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

high-risk atherosclerotic cardiovascular disease (ASCVD)

Interventions

statin:N/A
Hybutimibe Tablets and statin:N/A

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged>=18 years, male or female. 2.Diagnosed with very high-risk atherosclerotic cardiovascular disease (ASCVD). 3.Treated with a fixed-dose combination regimen of Hybutimibe tablets added to background statin therapy. 4.Availability of at least two or more follow-up visit records.

Exclusion criteria

Exclusion criteria: 1.Presence of other diseases or factors that may lead to secondary hypercholesterolemia, such as nephrotic syndrome, hypothyroidism, etc., or patients with drug-induced hypercholesterolemia. 2.Cases with incomplete medical records that preclude accurate assessment of drug exposure, efficacy, or safety. 3.Concurrent use of other medications affecting efficacy evaluation and safety, such as PCSK9 inhibitors, Xuezhikang, etc. (except for patients on stable therapy prior to the initiation of Hybutimibe combination treatment). 4.Vulnerable populations, including individuals with mental illness, cognitive impairment, critically ill patients, minors, and female subjects who are pregnant, lactating, or with a positive pregnancy test. 5.Any other conditions deemed by the investigator as unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Cardiac enzyme profile;Adverse Events (AEs) and Serious Adverse Events (SAEs);TC?TG?HDL-C?LDL-C?Apo B;Liver and kidney function;

Secondary

MeasureTime frame
Administration Details;

Countries

China

Contacts

Public ContactWenbin Zhang

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

3313011@zju.edu.cn+86 137 7757 2567

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026