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

Last Update: Jun 18, 2024

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)

ClinicalTrials.gov Identifier:

NCT05739383

Novartis Reference Number:CKJX839D12302

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Condition

Primary Prevention of Atherosclerotic Cardiovascular Disease

Phase

Phase3

Overall Status

Recruiting

Number of Participants

14000

Start Date

Mar 09, 2023

Completion Date

Apr 16, 2029

Gender

All

Age(s)

40 Years - 79 Years (Adult, Older Adult)

Interventions

Drug

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

Subcutaneous injection in pre-filled syringe.

Drug

Placebo in 1.5ml

Matching placebo in 1.5ml solution for injection

Eligibility 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.

Study Location

Valley Clinical Trials .

Recruiting

Northridge,California,91325,United States

Phone: 818-240-4220

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

Study Description

Interventions

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

Placebo in 1.5ml

Eligibility Criteria

Study Location

Valley Clinical Trials .

Mehrdad Ariani

Fahed Bitar

Jazmine Tran

Cardiology Associates Medical Group

Omid Fatemi

Angelica Medina

Lenzmeier Family Practice

Angela Allender Zwiebel

Thomas Lenzmeier

Stanford University Medical Center Center For Clinical Research

Joshua Knowles

Clinical Trials Research Sacramento

Jeffrey D Wayne

Leesa Koskela

Uni of California at Los Angeles

Matthew Jay Budoff

C for Endo Diabetes and MD

Sina Tebi

Interv Cardiology Med Grp

Farhad Rafii

Chase Medical Research LLC Research

Joseph Soufer

Maria Petruzzelli

National Heart Institute

Norman Lepor

Synexus Synexus

Rachel Fadden

Elysa Shaw

Alaska Heart and Vascular

Heather Craven

Jacob Kelly

Encompass Clinical Research

Andrea Bautista

Hanid Audish

Cardiovascular Res Found

Juan Ramos

Ronald P Karlsberg

California Medical Research Associates Inc

Oshadhi Perera

Ramachandra Patak

San Diego Cardiac Center

Diana Nguyen

Jiken Bhatt

The Center for Clinical Trials

Howard Rubenstein

Janice Orr

Longwood Research

Nahid Namdari

Saadat Ansari

Cognitive Clinical Trials LLC

Kenneth Steil

Ryan Morgan

Synexus Clinical Research Advantage

Adrienne Baltscheit

William Kirby

Kaiser Permanente San Diego Cardiology

Bahram Khadivi

Jaqueline Gomez Solis

University of California San Diego .

Marissa Dzotsi

Michael John Wilkinson

Clinical Research Advantage Fiel Family and Sports Med, PC

Kayla Wirkus

Thomas Fiel

Excel Medical Clinical Trials LLC

Quintin Spey

Seth J Baum

Bay Care Medical Group

Rakesh Sharma

Central Alabama Research

Barry McLean

Prateek Mishra