Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
NCT06941792 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1590
Last updated 2026-01-26
Summary
The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein cholesterol (LDL-C) change in 1 year, but also the LDL-C Test on Target for 1 year. This study further aims to assess the adherence, treatment patterns and satisfaction, and safety of inclisiran among Chinese patients.
Conditions
Interventions
- DRUG
-
inclisiran sodium injection
After randomization, patients in the inclisiran group will receive inclisiran sodium injection
- COMBINATION_PRODUCT
-
Standard of Care
After randomization switching to or adding on another/other lipid-lowering therapies
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-17
- Primary Completion
- 2026-01-30
- Completion
- 2026-01-30
Countries
- China
Study Locations
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