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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

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ClinicalTrials.gov Identifier: NCT05739383
Recruitment Status : Recruiting
First Posted : February 22, 2023
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Prevention of Atherosclerotic Cardiovascular Disease Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL Drug: Placebo in 1.5ml Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Actual Study Start Date : March 9, 2023
Estimated Primary Completion Date : April 16, 2029
Estimated Study Completion Date : April 16, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inclisiran sodium 300mg

Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe.

Randomized in a 1:1 ratio with matching placebo

 Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Subcutaneous injection in pre-filled syringe.
Other Name: KJX839
Placebo Comparator: Placebo
Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.
 Drug: Placebo in 1.5ml
Matching placebo in 1.5ml solution for injection


Outcome Measures
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Primary Outcome Measures :
  1. Time to the first occurrence of 4P-MACE [ Time Frame: Time to the first occurrence of 4P-MACE (up to approximately 75 months) ]
    4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.


Secondary Outcome Measures :
  1. Time to the first occurrence of 3P-MACE [ Time Frame: Time to the first occurrence of 3P-MACE (up to approximately 75 months) ]
    3-Point-Major Adverse Cardiovascular Events (3P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)

  2. Total number of first or repeated CV events (4P MACE) [ Time Frame: up to 75 months ]
    Total 4P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization)

  3. Total number of first or repeated CV events (3P MACE) [ Time Frame: up to 75 months ]
    Total 3P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke)

  4. Time to occurrence of Cardiovascular death [ Time Frame: Time to Cardiovascular death (up to 75 months) ]
    CV death is defined as death due to cardiovascular events.

  5. Time to occurrence of death due to any reason [ Time Frame: Time to all-cause mortality (up to 75 months) ]
    All-cause mortality is death due to any reason.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05739383


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05739383    
Other Study ID Numbers: CKJX839D12302
First Posted: February 22, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases