Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06941792
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Coronary Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • inclisiran sodium injection — DRUG
    After randomization, patients in the inclisiran group will receive inclisiran sodium injection
  • Standard of Care — COMBINATION_PRODUCT
    After randomization switching to or adding on another/other lipid-lowering therapies

Study Details

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.

Key Dates

Start date
Jun 17, 2025
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
1,590 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 [ Time Frame: 12 months ]

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