NCT05118230

Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

A Prospective, Observational Study to Assess the Real World Effectiveness of Inclisiran (Leqvio®) in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Hypercholesterolemia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
OTHER	Inclisiran	Prospective observational study. There is no treatment allocation. Chinese Patients who receive inclisiran in authorized health institutions are eligible to enroll into this study.

Timeline

• Start date: 2021-12-09
• Primary completion: 2024-07-20
• Completion: 2024-07-20
• First posted: 2021-11-11
• Last updated: 2024-08-07

Locations

2 sites across 1 country: China