Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

NCT06941792 · tracked via the Priya Life Science China tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 4

Started

2025-06-17

Last updated

2026-05-29

Condition(s) studied

Coronary Heart Disease

Investigational drug(s) / intervention(s)

inclisiran sodium injection →Standard of Care

inclisiran sodium injection: After randomization, patients in the inclisiran group will receive inclisiran sodium injection

Standard of Care: After randomization switching to or adding on another/other lipid-lowering therapies

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

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.

Primary outcome measure(s)

The percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline at 12 months, for the inclisiran group versus the standard of care (SoC) group — 12 months
To evaluate the real-world effectiveness of inclisiran, on the change in LDL-C levels at Month 12, compared with SoC, in Chinese patients with coronary heart disease (CHD)

Trial sites (19)

Facility	City	Region
Novartis Investigative Site	Anqing	Anhui
Novartis Investigative Site	Beijing	Beijing Municipality
Novartis Investigative Site	Chongqing	Chongqing Municipality
Novartis Investigative Site	Longyan	Fujian
Novartis Investigative Site	Jiamusi	Heilongjiang
Novartis Investigative Site	Zhengzhou	Henan
Novartis Investigative Site	Baotou	Inner Mongolia
Novartis Investigative Site	Shenyang	Liaoning
Novartis Investigative Site	Shenyang	Liaoning
Novartis Investigative Site	Jining	Shandong
Novartis Investigative Site	Weifang	Shandong
Novartis Investigative Site	Shanghai	Shanghai Municipality
Novartis Investigated Site	Taiyuan	Shanxi
Novartis Investigative Site	Chengdu	Sichuan
Novartis Investigative Site	Ürümqi	Xinjiang Uygur Autonomous Region
Novartis Investigative Site	Hangzhou	Zhejiang
Novartis Investigative Site	Jinhua	Zhejiang
Novartis Investigative Site	Ningbo	Zhejiang
Novartis Investigative Site	Wenzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06941792 on ClinicalTrials.gov ↗ ← All trials in China