This is a multi-center, prospective, comparative and non-interventional cohort study involving two cohorts, one cohort (Inclisiran Cohort) of patients treated with inclisiran in certain special territories in China (eg. Bo'ao Pilot Zone) and the other cohort (SoC Historical Cohort) of patients treated with standard of care (SoC) in routine clinical practice from EMR database.
This study will utilize real-world data from EMR database to serve as the 'external control'.The purpose of this study is to compare the effectiveness of inclisiran as an add-on therapy (or monotherapy in statin-intolerant cases) in real-world settings, with current SoC in a matched historical cohort of patients who receive SoC in EMR database. The patients in Inclisiran Cohort will received inclisiran injection (300 mg s.c.) under the guidance of physicians, and based on the approved label, which recommends a second dose on 90 days after the first injection, and then followed by injections every 6 months afterwards until the end of study (EOS). However, the treatment decision and exact visit timepoint will be purely decided by physicians and patients.
Study Type
OBSERVATIONAL
Enrollment
61
Prospective observational study. There is no treatment allocation. Chinese Patients who receive inclisiran in authorized health institutions are eligible to enroll into this study.
Novartis Investigative Site
Haikou, Hainan, China
Novartis Investigative Site
Qionghai, Hainan, China
Percentage change in LDL-C from baseline
To assess the real-world effectiveness of inclisiran plus SoC in reducing LDL-C in reference to a matched historical cohort of SoC.
Time frame: Baseline, Day 330
Change in LDL-C from baseline
Percentage and absolute change will be provided
Time frame: Baseline, Day 90, Day 150, Day 270, Day 330,Day 450 and Day 510
Change in total cholesterol, HDL-C, Lp(a) and triglycerides from baseline
Percentage and absolute change will be provided
Time frame: Baseline, Day 90, Day 150, Day 270, Day 330, Day 450 and Day 510
Proportion of patients discontinuing from inclisiran during the study and the reasons for treatment discontinuation if available
If the planned dose is missed for more than 3 months, the patient is considered as discontinuation.
Time frame: Day 150
Proportion of patients with treatment switch and reinitiation during the study
* Switch: defined as patient starts monoclonal antibody treatment directed towards PCSK9. Switching date is defined as the date of the first claim of the new therapy. * Reinitiation: defined as patient previously discontinues inclisiran \> 9 months (from last dose received), and then reinitiates inclisiran.
Time frame: Day 150
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