Hyperlipidemia
Conditions
Interventions
Group A(Q2W):None
Group B(Q3W):None
Sponsors
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Age >=18 years. 2)Patients with hyperlipidemia who have been regularly taking medium-dose statins (e.g., atorvastatin 10 mg/day, rosuvastatin 5 mg/day, fluvastatin 80 mg/day, pitavastatin 2–4 mg/day, pravastatin 40 mg/day, simvastatin 20–40 mg/day, Xuezhikang 1.2 g/day) for at least 4 weeks prior to enrollment, regardless of whether a cholesterol absorption inhibitor is co-administered. 3)LDL-C levels do not meet the target corresponding to the patient’s ASCVD risk category, specifically: For low-risk patients in primary prevention of ASCVD: LDL-C >= 3.4 mmol/L;For intermediate- or high-risk patients in primary prevention of ASCVD: LDL-C >= 2.6 mmol/L;For very-high-risk patients in secondary prevention of ASCVD: LDL-C >= 1.8 mmol/L or reduction from baseline = 1.4 mmol/L or reduction from baseline <= 50%. 4)Meeting the criteria for PCSK9 inhibitor use, or the clinician anticipates that LDL-C will remain off-target even with continued medium-dose statin therapy (with or without a cholesterol absorption inhibitor), and thus combination with a PCSK9 inhibitor is required. 5)First-time use of Tafolecimab. 6)Voluntarily participate, provide written informed consent, and be able to comply with follow-up requirements. 7)All of the above criteria must be met for inclusion in the study.
Exclusion criteria
Exclusion criteria: 1)Significant abnormal liver function at enrollment: Alanine aminotransferase and/or aspartate aminotransferase levels exceeding 3 times the upper limit of the normal reference range. 2)Renal insufficiency at enrollment: Serum creatinine level above the upper limit of the normal reference range and/or endogenous creatinine clearance rate below the lower limit of the normal reference range. 3)Severe cardiac dysfunction: Left ventricular ejection fraction <=30%. 4)Secondary dyslipidemia caused by factors such as thyroid dysfunction, nephrotic syndrome, or familial hyperlipidemia. 5)Patients with connective tissue diseases, rheumatic or immune system disorders, rhabdomyolysis, hematologic diseases, malignant tumors, or other intracranial diseases. 6)Patients with a history of allergy to statins or Tafolecimab injection, or those with known contraindications. 7)History of major surgery or trauma, or occurrence of severe acute or chronic infections during the follow-up period. 8)Pregnant women. 9)Patients with serious diseases and a life expectancy of <=3 months, such as those with malignant tumors. 10)Any other condition deemed unsuitable by the investigator, including medical or non-medical factors that may increase participant risk, interfere with study evaluation, or affect study completion. 11)Meeting any of the above criteria will lead to exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in LDL-C at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Lp(a) at Week 12;LDL-C Goal Attainment Rate at Each Visit;Change from Baseline in HDL-C, TC, TG, non-HDL, ApoB, ApoA1 at Each Visit; | — |
Countries
China
Contacts
Public ContactGao Mei
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial
Outcome results
None listed