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ACTIVE NOT RECRUITING
NCT06941792
PHASE4

Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: Effectiveness of Inclisiran for Patients With Coronary Heart Disease in China: a Multicenter, Standard of Care-Controlled Pragmatic Randomized Trial

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

1590

Start Date

2025-06-17

Completion Date

2026-01-30

Last Updated

2026-01-26

Healthy Volunteers

No

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

Locations (19)

Novartis Investigative Site

Anqing, Anhui, China

Novartis Investigative Site

Beijing, Beijing Municipality, China

Novartis Investigative Site

Chongqing, Chongqing Municipality, China

Novartis Investigative Site

Longyan, Fujian, China

Novartis Investigative Site

Jiamusi, Heilongjiang, China

Novartis Investigative Site

Zhengzhou, Henan, China

Novartis Investigative Site

Baotou, Inner Mongolia, China

Novartis Investigative Site

Shenyang, Liaoning, China

Novartis Investigative Site

Shenyang, Liaoning, China

Novartis Investigative Site

Jining, Shandong, China

Novartis Investigative Site

Weifang, Shandong, China

Novartis Investigative Site

Shanghai, Shanghai Municipality, China

Novartis Investigated Site

Taiyuan, Shanxi, China

Novartis Investigative Site

Chengdu, Sichuan, China

Novartis Investigative Site

Ürümqi, Xinjiang Uygur Autonomous Region, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Jinhua, Zhejiang, China

Novartis Investigative Site

Ningbo, Zhejiang, China

Novartis Investigative Site

Wenzhou, Zhejiang, China