for people ages 40-79 (full criteria)
at San Diego, California and other locations
study started
completion around
Principal Investigator
by Michael John Wilkinson
Headshot of Michael John Wilkinson
Michael John Wilkinson



CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

Official Title

A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)


The purpose of this study is to evaluate inclisiran sodium 300 mg s.c. (equivalent to 284 mg inclisiran) compared to placebo on reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event.

Randomized participants will receive study medication (inclisiran or placebo), administered s.c. on Day 1, Day 90, then every 6 months thereafter. This is an event-driven study. Therefore, the study will continue until the required number of clinical events have occurred across both treatment arms, and all participants have a minimum of 3 years of follow-up during the double-blind treatment period.


Primary Prevention of Atherosclerotic Cardiovascular Disease, Inclisiran, PCSK9, primary prevention, cardiovascular disease, MACE, myocardial infarction, stroke, LDL-C, hyperlipidemia, hypercholesterolemia, dyslipidemia, cholesterol, Coronary Artery Disease (CAD), Non-Obstructive Coronary Artery Disease (NOCAD), Coronary Artery Calcium, Coronary artery stenosis, Coronary angiogram, Cardiovascular Diseases, Atherosclerosis, Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, Inclisiran sodium 300mg


You can join if…

Open to people ages 40-79

  • At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
    1. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but <50% in the left main coronary artery or stenosis ≥20% but <70% in any other major epicardial coronary artery, or
    2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
    3. High 10-year ASCVD risk ≥20%, or
    4. Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
  • LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.

You CAN'T join if...

  • History of major ASCVD event.
  • History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
  • Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
  • Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
  • Active liver disease or hepatic dysfunction
  • Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
  • Pregnant or nursing (lactating) women
  • Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration

    Other protocol-defined inclusion/exclusion criteria may apply.


  • University of California San Diego . accepting new patients
    San Diego California 92103 United States
  • San Diego Cardiac Center accepting new patients
    San Diego California 92123 United States
  • Kaiser Permanente San Diego Cardiology accepting new patients
    San Diego California 92108 United States
  • Acclaim Clinical Research accepting new patients
    San Diego California 92120 United States
  • Encompass Clinical Research accepting new patients
    Spring Valley California 91978 United States
  • Blue Coast Research Center LLC . accepting new patients
    Vista California 92081 United States

Lead Scientist at UCSD

  • Michael John Wilkinson
    Assistant Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 17 research publications


accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 3 research study
Study Type
Expecting 14000 study participants
Last Updated