Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

Launched by NOVARTIS PHARMACEUTICALS · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called inclisiran in treating Chinese patients with coronary heart disease (CHD). The main goal is to see how well inclisiran can lower levels of bad cholesterol (LDL-C) compared to standard treatments over one year. Researchers will also look at how well patients stick to their treatment, their satisfaction with it, and any safety concerns.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of coronary heart disease. You should also have been on the highest dose of statin medication (a common cholesterol-lowering drug) for at least four weeks but still have high LDL-C levels (1.8 mmol/L or more). However, you cannot join if you have taken inclisiran in the last two years or are currently involved in another clinical trial. If you decide to participate, you’ll be asked to sign a consent form and will be monitored closely throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent must be obtained prior to participation in the study
• • 2. Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
• • 3. Aged ≥18 years at randomization
• • 4. Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L).
• • The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication.
• Exclusion Criteria:
• • 1. Received inclisiran during the 2 years prior to the screening.
• • 2. Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
• • 3. Participating in an interventional trial at enrollment
• • 4. Having severe liver disorder (Child-Pugh class C)
• • 5. Any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment.
• • Other protocol-defined inclusion/exclusion criteria may apply.