NCT06941792

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,590

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

March 6, 2025

Last Update Submit

January 23, 2026

Conditions

Coronary Heart Disease

Keywords

Inclisiraneffectivenesslipid-loweringlow-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

  • +20 more secondary outcomes

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 injectionDRUG

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

inclisiran group
Standard of CareCOMBINATION_PRODUCT

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

Standard of Care group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth 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

January 30, 2026

Study Completion

January 30, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Locations

CN(19)