Effectiveness of Inclisiran for Patients With Coronary Heart Disease in China: a Multicenter, Standard of Care-Controlled Pragmatic Randomized Trial
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Signed informed consent must be obtained prior to participation in the study
• Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
• Aged ≥18 years at randomization
• 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.
Locations
Other Locations
China
Novartis Investigative Site
RECRUITING
Anqing
Novartis Investigative Site
RECRUITING
Baotou
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Chengdu
Novartis Investigative Site
RECRUITING
Chongqing
Novartis Investigative Site
RECRUITING
Hangzhou
Novartis Investigative Site
RECRUITING
Jiamusi
Novartis Investigative Site
RECRUITING
Jinhua
Novartis Investigative Site
RECRUITING
Jining
Novartis Investigative Site
RECRUITING
Longyan
Novartis Investigative Site
RECRUITING
Ningbo
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shenyang
Novartis Investigative Site
RECRUITING
Shenyang
Novartis Investigated Site
RECRUITING
Taiyuan
Novartis Investigative Site
RECRUITING
Ürümqi
Novartis Investigative Site
RECRUITING
Weifang
Novartis Investigative Site
NOT_YET_RECRUITING
Wenzhou
Novartis Investigative Site
RECRUITING
Wenzhou
Novartis Investigative Site
RECRUITING
Zhengzhou
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date:2025-06-17
Estimated Completion Date:2026-01-30
Participants
Target number of participants:1590
Treatments
Experimental: inclisiran group
patients in the inclisiran group will receive inclisiran (may or may not plus cholesterol absorption inhibitor at the discretion of the treating physician).
Active_comparator: Standard of Care group
Patients in the SoC group will switch to/add on another/other LLT(s) at the discretion of the treating physician, as long as it is not inclisiran or an investigational drug.