Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (V-PLAQUE)

May 28, 2026 updated by: Novartis Pharmaceuticals

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase IIIb Study Evaluating the Effect of Inclisiran on Atherosclerotic Plaque Progression Assessed by Coronary Computed Tomography Angiography (CCTA) in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (VICTORION-PLAQUE)

CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to evaluate the efficacy of inclisiran compared to placebo on top of maximally tolerated dose of statin therapy in reducing total coronary atheroma volume assessed by CCTA in participants with a diagnosis of Non-Obstructive Coronary Artery Disease (NOCAD) without previous cardiovascular events, who have an LDL-C ≥55 mg/dL (1.4 mmol//L), no significant pressure drop in Fractional Flow Reserve Computed Tomography (FFRCT) and a CT-adapted Leaman score >5 despite the use of maximally tolerated statin therapy(and if applicable, another LLT on top of statin therapy for at least 30 days in up to 20% of randomized participants).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
608

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1428DCO
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1119ACN
        • Novartis Investigative Site
  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Novartis Investigative Site
      • Chemside, Queensland, Australia, 4032
        • Novartis Investigative Site
      • Milton, Queensland, Australia, 4064
        • Novartis Investigative Site
    • South Australia
      • Leabrook, South Australia, Australia, 5068
        • Novartis Investigative Site
  • Belgium
    • Antwerpen
      • Turnhout, Antwerpen, Belgium, 2300
        • Novartis Investigative Site
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Novartis Investigative Site
      • Hasselt, Limburg, Belgium, 3500
        • Novartis Investigative Site
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Novartis Investigative Site
    • Oost Vlaanderen
      • Aalst, Oost Vlaanderen, Belgium, 9300
        • Novartis Investigative Site
  • Brazil
      • São Paulo, Brazil, 01409-902
        • Novartis Investigative Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80040-050
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
        • Novartis Investigative Site
  • Canada
    • Ontario
      • North York, Ontario, Canada, M6B 3H7
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Novartis Investigative Site
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8380465
        • Novartis Investigative Site
  • China
      • Beijing, China, 100050
        • Novartis Investigative Site
      • Shanghai, China, 200080
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100013
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 211166
        • Novartis Investigative Site
  • France
      • Paris, France, 75013
        • Novartis Investigative Site
      • Pessac, France, 33604
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H-1083
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Novartis Investigative Site
  • India
      • New Delhi, India, 110025
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560069
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Novartis Investigative Site
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600006
        • Novartis Investigative Site
      • Coimbatore, Tamil Nadu, India, 641009
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Novartis Investigative Site
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Novartis Investigative Site
  • Ireland
      • Galway, Ireland, H91 YR71
        • Novartis Investigative Site
    • Ireland
      • Dublin, Ireland, Ireland, D03 VX82
        • Novartis Investigative Site
  • Italy
    • MI
      • Milan, MI, Italy, 20138
        • Novartis Investigative Site
      • Milan, MI, Italy, 20157
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
  • Japan
      • Kyoto, Japan, 6078062
        • Novartis Investigative Site
    • Miyazaki
      • Miyhazaki, Miyazaki, Japan, 8802102
        • Novartis Investigative Site
    • Okinawa
      • Urasoe, Okinawa, Japan, 901-2102
        • Novartis Investigative Site
    • Osaka
      • Izumisano, Osaka, Japan, 5988577
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03722
        • Novartis Investigative Site
      • Seoul, South Korea, 07804
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bundang Gu, Gyeonggi-do, South Korea, 13620
        • Novartis Investigative Site
      • Goyang-si, Gyeonggi-do, South Korea, 10380
        • Novartis Investigative Site
  • Spain
      • A Coruña, Spain, 15006
        • Novartis Investigative Site
      • Barcelona, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Córdoba, Spain, 14004
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Novartis Investigative Site
      • Valencia, Spain, 46010
        • Novartis Investigative Site
  • Switzerland
      • Geneva, Switzerland, 1211
        • Novartis Investigative Site
      • Lugano, Switzerland, 6900
        • Novartis Investigative Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Novartis Investigative Site
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Novartis Investigative Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research Llc
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Heart and Vascular
    • California
      • Beverly Hills, California, United States, 90210
        • Cardiovascular Res Found
      • La Jolla, California, United States, 92037
        • UC San Diego Health
      • Stanford, California, United States, 94305
        • Stanford Health Care
      • Torrance, California, United States, 90509-2910
        • Lundquist Inst BioMed at Harbor
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • George Washington Univ Medical Ctr
    • Florida
      • Miami Lakes, Florida, United States, 33014
        • Inpatient Research Clinical LLC
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Reid Physician Associates
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Midwest Heart and Vascular Spec
    • Maryland
      • Ft. Washington, Maryland, United States, 20744
        • Anderson Medical Research
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • R Ins For Heart And Vascular Health
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Cardio Metabolic Institute
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Med at Mt Sinai
      • Stony Brook, New York, United States, 11794-3362
        • State Uni of NY at Stony Brook
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Texas
      • Dallas, Texas, United States, 75226
        • Soltero Cardiovascular Research Center
      • Houston, Texas, United States, 77034
        • Orion Medical
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-Cardiovascular Research
      • Seattle, Washington, United States, 98195
        • Univ of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female ≥18 years or ≤80 years of age at signing of informed consent.
  • Fasting LDL-C local lab value at the Screening Visit of either i) ≥100 mg/dL (2.6 mmol/L) if on statin therapy but not on a maximally tolerated statin therapy; ii) ≥150 mg/dL (3.9mmol/L) if statin naive and without documented statin intolerance; or iii) ≥55 mg/dL (1.4 mmol/L) if on a stable (≥4 weeks) dose of maximally tolerated statin therapy or if statin intolerant.
  • Fasting LDL-C local lab value ≥55 mg/dL (1.4 mmol/L) at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period.

  • Participants having NOCAD without previous cardiovascular events: NOCAD is defined as:.

    1. Participant with CT-adapted Leaman score >5. and a diameter stenosis <50% or
    2. Participants with a CT-adapted Leaman score >5, a diameter stenosis ≥50% but with FFRCT ≥0.76.
  • A standard of care CCTA may serve as the study baseline CCTA scan if it is performed within 3 months prior to the participant's Screening Visit and meets the inclusion criteria of FFRct >0.8 and CT-adapted Leaman score >5, which will be assessed by the Imaging Core Lab.
  • At the Baseline Visit, participants must be on a stable (≥4 weeks) dose of maximally tolerated statin therapy. Participants not on maximally tolerated statin therapy and who do not have documented statin intolerance can be screened but must enter the study via a Statin Optimization Period.
  • Fasting LDL-C lab value ≥55 mg/dL (1.4 mmol/L) at the Baseline Visit, measured at the central laboratory. If the Baseline and Screening Visits occur on the same day, then the LDL-C assessment will be assessed on the central laboratory sample. If a participant qualifies at Screening but the fasting central lab LDL-C value at the Baseline visit does not meet eligibility, then eligibility will be determined based on the central lab result.
  • Fasting triglycerides value <400 mg/dL (4.52 mmol/L) based on the local lab results at the Screening visit and on the central lab results at the CCTA visit.

Exclusion Criteria:

  • Previous cardiovascular events history including myocardial infarction (MI), or prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
  • Planned revascularization (PCI) or (CABG).

  • Previous cerebrovascular events including:

    • Prior ischemic stroke thought not to be caused by atrial fibrillation, valvular heart disease or mural thrombus.
    • History of prior percutaneous or surgical carotid artery revascularization.

  • History of Peripheral Artery Disease (PAD):

    • Prior documentation of a resting ankle-brachial index <0.85.
    • History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery.
    • Prior non-traumatic amputation of a lower extremity due to peripheral artery disease.

  • Cardiac disorders, including any of the following:

    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation) within 3 months prior to randomization that is not controlled by medication or via ablation at the time of the Screening Visit.
    • Complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) prior to randomization.
  • Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA Visit as assessed by the Imaging Core Lab.
  • Pacemaker or implantable cardioverter-defibrillator (ICD) in situ.
  • Systolic Left Ventricle Ejection Fraction <30% at the Screening Visit.
  • Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy.
  • Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit.
  • Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit and at the Statin Optimization 3 Visit.
  • Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit.
  • Local creatine kinase (CK) values of either, unless a more stringent threshold is mandated by a local regulatory authority
  • Local CK values ≥5x ULN at the Statin Optimization 3 Visit unless a more stringent threshold is mandated by a local regulatory authority
  • Participant with myopathy at the Statin Optimization 3 Visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Subcutaneous injection
Drug: Placebo
Subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months thereafter.
Experimental: Inclisiran sodium
Subcutaneous injection
Drug: Inclisiran sodium 300 mg
Subcutaneously administered on Days 1, Month 3 (Day 90), and every 6 months thereafter.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change in total coronary atheroma volume
Time Frame: From baseline to month 24
Evaluating inclisiran compared to placebo both on top of maximally tolerated statin therapy in reducing total coronary atheroma volume assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease (NOCAD) without previous cardiovascular events.
From baseline to month 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage change in LDL-C
Time Frame: From baseline to month 24
Full fasting lipid panel will be collected throughout the study beginning at baseline.
From baseline to month 24
Percentage change in low attenuation plaque volume evaluated by CCTA
Time Frame: From baseline to month 24
Evaluating inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA.
From baseline to month 24
Percentage of participants with progression, regression, or no change of total plaque atheroma volume
Time Frame: From baseline to month 24
Evaluating inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total atheroma volume.
From baseline to month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CKJX839D12303
  • 2021-004601-47 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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