Hyperlipidemia
Conditions
Interventions
Inclisiran Prioritized Treatment Group (Statin Combined with Inclisiran or Inclisiran Monotherapy):NA
Conventional treatment group (statin combined with ezetimibe/pembrolizumab/PCSK9mAb):NA
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with primary hypercholesterolemia in China who are at moderate to high risk of ASCVD, either receiving treatment with the maximum tolerated dose of statins or statin intolerant, and have not achieved their LDL-C target at the time of consultation, as assessed using the 2023 edition of the Chinese Dyslipidemia Management Guidelines. 2. Age = 18 years. 3. Must have received at least one injection of Inclisiran during the enrollment period. 4. A signed informed consent form must be obtained prior to study participation.
Exclusion criteria
Exclusion criteria: 1. Patients with severe liver disease (Child-Pugh Class C). 2. Participation in other interventional studies during the study period. 3. Receipt of Inclisiran treatment within 2 years prior to screening or receipt of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) monoclonal antibody (mAb) therapy within 3 months prior to screening. 4. Patients directly assessed as ASCVD very high risk, extremely high risk, or high risk based on the ASCVD evaluation process outlined in the 2023 edition of the Chinese Dyslipidemia Management Guidelines, including any of the following: - (1) LDL-C = 4.9 mmol/L or TC = 7.2 mmol/L; - (2) Diabetes mellitus patients (= 40 years old); - (3) CKD stage 3-4. 5. Any other condition that, according to the investigator (or their designee), may pose substantial risk to the participant if they join the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASCVD Risk Levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| LDL-C Reduction Magnitude;Medication Adherence;Carotid plaque thickness;Carotid plaque volume;Major Adverse Cardiovascular Events (MACE); | — |
Countries
China
Contacts
Public ContactJia Yu
West China Hospital of Sichuan University
Outcome results
None listed