Active — Not RecruitingPhase 4

Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

China1,590 participantsStarted 2025-06-17

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT06941792

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-30

View on ClinicalTrials.gov More Coronary Heart Disease trials