Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

NCT06941792 | Active Not Recruiting Phase 4

• 1 other identifier: CKJX839A1CN06
• Study Type: interventional
• Target: 1,590
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Coronary Heart Disease

Keywords

Inclisiran; effectiveness; lipid-lowering; low-density lipoprotein cholesterol Test on Target

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  12 months

Secondary Outcomes (25)

• The proportion of participants with the 1-year LDL-C Test on Target ≥75%, for the inclisiran group versus the SoC group

  12 months

• The percentage change in LDL-C level from baseline at 3 months, 6 months, and 9 months, for the inclisiran group versus the SoC group

  At Month 3, Month 6 and Month 9

• The proportion of participants with LDL-C <1.8 mmol/L at 12 months, for the inclisiran group versus the SoC group

  12 months

• To describe LDL-C Test on Target value during the 12 months after baseline, for the inclisiran group and the SoC group.

  12 months

• The percentage change in levels of total cholesterol, triglyceride, HDL-C, Lp(a), ApoA, and ApoB, from baseline at 3 months, 6 months, 9 months, and 12 months, for the inclisiran group versus the SoC group

  At Month 3, Month 6, Month 9, and Month 12

Study Arms (2)

inclisiran group

EXPERIMENTAL

patients in the inclisiran group will receive inclisiran (may or may not plus cholesterol absorption inhibitor at the discretion of the treating physician).

Drug: inclisiran sodium injection

Standard of Care group

ACTIVE COMPARATOR

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.

Combination Product: Standard of Care

Interventions

inclisiran sodium injection DRUG

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

inclisiran group

Standard of Care COMBINATION_PRODUCT

After randomization switching to or adding on another/other lipid-lowering therapies

Standard of Care group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Received inclisiran during the 2 years prior to the screening.
• Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
• Participating in an interventional trial at enrollment
• Having severe liver disorder (Child-Pugh class C)
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (19)

Novartis Investigative Site

Anqing, Anhui, 246003, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 102218, China

Location

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400010, China

Location

Novartis Investigative Site

Longyan, Fujian, 364099, China

Location

Novartis Investigative Site

Jiamusi, Heilongjiang, 154002, China

Location

Novartis Investigative Site

Zhengzhou, Henan, 451400, China

Location

Novartis Investigative Site

Baotou, Inner Mongolia, 014010, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110016, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 121100, China

Location

Novartis Investigative Site

Jining, Shandong, 272000, China

Location

Novartis Investigative Site

Weifang, Shandong, 261000, China

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200065, China

Location

Novartis Investigated Site

Taiyuan, Shanxi, 030000, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610031, China

Location

Novartis Investigative Site

Ürümqi, Xinjiang Uygur Autonomous Region, 830054, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310007, China

Location

Novartis Investigative Site

Jinhua, Zhejiang, 321000, China

Location

Novartis Investigative Site

Ningbo, Zhejiang, 315000, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 24, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (19)