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A Prospective Observational Cohort Study Evaluating Long-term Lipid Goal Achievement and Clinical Outcomes in Patients with Cardiometabolic Diseases Receiving PCSK9 Inhibitors Plus Standard Therapy

Effect of PCSK9 Inhibitors Combined with Standard Therapy on Long-term Lipid Goal Achievement and Clinical Outcomes in Patients with Cardiometabolic Diseases: A Prospective Observational Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116995
Enrollment
Unknown
Registered
2026-01-19
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Cardiometabolic Disease

Interventions

PCSK9 group: Addition of PCSK9 inhibitor to standard therapy:None
Control group: Continuation of standard lipid-lowering therapy (statin+/- ezetimibe):None

Sponsors

The First Hospital of Qinhuangdao
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Confirmed diagnosis of at least one atherosclerotic cardiovascular disease (coronary heart disease, ischemic stroke/TIA, or peripheral artery disease); 3. Meet CMD criteria with concomitant diabetes, obesity, metabolic syndrome, or dyslipidemia; 4. Receiving stable lipid-lowering therapy but with uncontrolled lipid levels, planning to use PCSK9 inhibitors or continue standard therapy; 5. Voluntarily participating in the study and having signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Has received PCSK9 inhibitor treatment within the past 2 months; 2. Severe hepatic or renal insufficiency; 3. Active malignancy or expected survival time < 1 year; 4. Pregnant or lactating women; 5. Inability to complete follow-up or incomplete data.

Design outcomes

Primary

MeasureTime frame
LDL-C goal attainment rate at 12 months;LDL-C goal attainment rate at 24 months;

Secondary

MeasureTime frame
Non-HDL-C goal attainment rate;Incidence of major adverse cardiovascular events;Hospitalization rate;

Countries

China

Contacts

Public ContactMa Lixiang

The First Hospital of Qinhuangdao

mlxqhddyyy@163.com+86 335 590 8966

Outcome results

None listed

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