MedDataX Logo

Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

NCT ID: NCT06941792

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-17

Study Completion Date

2026-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is a multicenter, randomized, parallel, open-label, pragmatic trial, to assess the effectiveness of inclisiran in the real-world compared to SoC, in patients with CHD in China who did not achieve LDL-C goal despite maximally tolerated statin therapy for ≥4weeks stable using. CHD patients include patients with acute coronary syndrome and patients with chronic coronary syndrome.

After granting informed consent, being screened, and confirmed eligible for the study, participants will be randomized to 2 arms (inclisiran or SoC) in a 1:1 ratio.

Following the randomization, participants start inclisiran or SoC adaptation (which means switching to or adding on another/other lipid-lowering therapies (LLT\[s\]). This start date is defined as Day 0.

During follow-up, each participant will follow routine care, and the results of LDL-C tests will be collected for each Visit (every 3 months), with an allowable window of ±1.5 months. Each patient will be followed up until his/her end of study (EOS), which is the earliest of the end of follow-up period (Visit 4: approximately 12 months following Day 0), lost to follow-up, consent withdrawal, death, and participating in another interventional trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Heart Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

inclisiran sodium injection

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type COMBINATION_PRODUCT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

inclisiran sodium injection

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

Intervention Type DRUG

Standard of Care

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study
2. Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
3. Aged ≥18 years at randomization
4. 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.

Exclusion Criteria

1. Received inclisiran during the 2 years prior to the screening.
2. Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
3. Participating in an interventional trial at enrollment
4. Having severe liver disorder (Child-Pugh class C)
5. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Anqing, Anhui, China

Site Status RECRUITING

Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status RECRUITING

Novartis Investigative Site

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Novartis Investigative Site

Longyan, Fujian, China

Site Status RECRUITING

Novartis Investigative Site

Jiamusi, Heilongjiang, China

Site Status RECRUITING

Novartis Investigative Site

Zhengzhou, Henan, China

Site Status RECRUITING

Novartis Investigative Site

Baotou, Inner Mongolia, China

Site Status RECRUITING

Novartis Investigative Site

Shenyang, Liaoning, China

Site Status RECRUITING

Novartis Investigative Site

Shenyang, Liaoning, China

Site Status RECRUITING

Novartis Investigative Site

Jining, Shandong, China

Site Status RECRUITING

Novartis Investigative Site

Weifang, Shandong, China

Site Status RECRUITING

Novartis Investigative Site

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Novartis Investigated Site

Taiyuan, Shanxi, China

Site Status RECRUITING

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status RECRUITING

Novartis Investigative Site

Ürümqi, Xinjiang Uygur Autonomous Region, China

Site Status RECRUITING

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status RECRUITING

Novartis Investigative Site

Jinhua, Zhejiang, China

Site Status RECRUITING

Novartis Investigative Site

Ningbo, Zhejiang, China

Site Status RECRUITING

Novartis Investigative Site

Wenzhou, Zhejiang, China

Site Status RECRUITING

Novartis Investigative Site

Wenzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CKJX839A1CN06

Identifier Type: -

Identifier Source: org_study_id