In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05974345
Status
Completed

Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

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

Interventions

  • Inclisiran sodium — DRUG
    Drug: Inclisiran sodium 300 mg virtually subcutaneously administered on Day 1, Month 3 (Day 90) and every 6 months thereafter until end of simulation.
  • Placebo — DRUG
    Drug: Placebo virtually subcutaneously administered on Day 1, Month 3 (Day 90) and every 6 months thereafter until end of simulation.
  • Ezetimibe — DRUG
    Drug: Ezetimibe 10 mg virtually orally once a day until end of simulation.
  • Evolocumab — DRUG
    Drug: Evolocumab 140 mg virtually subcutaneously administered every two weeks until end of simulation.

Study Details

Study CKJX839B1FR01 in an In silico trial to predict the efficacy of Inclisiran therapy on major adverse cardiovascular events (MACE) and cardiovascular (CV) death in virtual patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.

Key Dates

Start date
Nov 3, 2023
Status verified
May 2024
Primary completion
Dec 15, 2023
Completion
Dec 15, 2023

Study Design

Enrollment
204,691 participants (actual)

Arms

  • Arm: Virtual Patient with ASCVD
    Virtual Patient with ASCVD and LDL-C ≥ 70 mg/dL despite receiving a well-tolerated high-intensity statin with or without ezetimibe. Each virtual patient is his own control.

Primary Outcome Measure

Time to the first occurrence between trial start and end of follow-up of any component of 3P-MACE (composite of CV death, non-fatal MI or non-fatal ischemic stroke) [ Time Frame: 5 years of follow-up ]

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