A multicenter, prospective, observational, open-label study comparing the differences in efficacy and safety of combining hybutimibe or ezetimibe after moderate-intensity statin therapy fails to achieve treatment goals in very-high-risk and extremely-high-risk ASCVD patients in real-world clinical settings

A multicenter, prospective, observational, open-label study comparing the differences in efficacy and safety of combining hybutimibe or ezetimibe after moderate-intensity statin therapy fails to achieve treatment goals in very-high-risk and extremely-high-risk ASCVD patients in real-world clinical settings

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600122266

Enrollment

Unknown

Registered

2026-04-10

Start date

2026-04-11

Completion date

Unknown

Last updated

2026-04-14

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

Conditions

atherosclerotic cardiovascular diseases

Interventions

Observation group(Moderate-intensity statin combined with hybutimibe 10 mg/d):None

Control group(Moderate-intensity statin combined with ezetimibe be 10 mg/d):None

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 years and = LDL-C >= 1.8 mmol/L; (2) For extremely-high-risk patients: 3.4 mmol/L >= LDL-C >= 1.4 mmol/L; 6.Able to understand and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.History of allergy to cholesterol absorption inhibitors or their excipients; 2.Use of lipid-lowering PCSK9 inhibitors within the past 6 months; 3.Women who are pregnant or planning to become pregnant; 4.Breastfeeding women; 5.Active liver disease, or persistently elevated liver enzymes (ALT/AST/GGT) of unknown cause; 6.Any clinically serious endocrine disorder affecting blood lipids or lipoproteins, including thyroid dysfunction and nephrotic syndrome; 7.Inability to adhere to medication or comply with regular follow-up; 8.Other conditions deemed by the investigator as inappropriate for participation in this study.

Design outcomes

Primary

Measure	Time frame
The rate of change in LDL-C from baseline after 12 weeks of treatment;	—

Secondary

Measure	Time frame
Changes in lipid parameters TC from baseline at week 4 and week 12 of treatment;Changes in lipid parameters TG from baseline at week 4 and week 12 of treatment;Changes in lipid parameters HDL-C from baseline at week 4 and week 12 of treatment;Changes in lipid parameters ApoB from baseline at week 4 and week 12 of treatment;LDL-C target attainment rate;Rate of change in serum creatinine (Cr), creatinine clearance (CrCl), and glomerular filtration rate (GFR) from baseline at 12 weeks;Incidence of transaminase elevation >=3×ULN or creatine kinase elevation >=5×ULN at 12 weeks;	—

Measure

Time frame

Changes in lipid parameters TC from baseline at week 4 and week 12 of treatment;Changes in lipid parameters TG from baseline at week 4 and week 12 of treatment;Changes in lipid parameters HDL-C from baseline at week 4 and week 12 of treatment;Changes in lipid parameters ApoB from baseline at week 4 and week 12 of treatment;LDL-C target attainment rate;Rate of change in serum creatinine (Cr), creatinine clearance (CrCl), and glomerular filtration rate (GFR) from baseline at 12 weeks;Incidence of transaminase elevation >=3×ULN or creatine kinase elevation >=5×ULN at 12 weeks;

—

Countries

China

Contacts

Public ContactFeng Gaoke

Renmin Hospital of Wuhan University

123fgk@163.com+86 131 6330 5123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026