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Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Sponsor: Novartis Pharmaceuticals
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
Conditions
Interventions
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
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