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Coronary Artery DiseasePhase 3V-PLAQUENCT05360446

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

A Phase 3 study testing Inclisiran sodium 300 mg in people with Coronary Artery Disease, run by Novartis Pharmaceuticals at 89 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Inclisiran sodium 300 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
610 participants
Where
89 sitesin 18 countries
Study dates
8 Jul 2022to 27 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:.
  • Participant with CT-adapted Leaman score >5. and a diameter stenosis <50% or
  • Participants with a CT-adapted Leaman score >5, a diameter stenosis ≥50% but with FFRCT ≥0.76.
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  • 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.

Who cannot join

  • 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):
Show all 22Show fewer
  • 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.

Trial locations and contacts

89 sites in 18 countries.

89 sites in 18 countries

United States27 sites

  • Alaska Heart and Vascular

    Anchorage, Alaska, 99508

  • Cardiovascular Res Found

    Beverly Hills, California, 90210

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Aultman Hospital

    Canton, Ohio, 44710

  • Soltero Cardiovascular Research Center

    Dallas, Texas, 75226

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Virginia Heart

    Falls Church, Virginia, 22042

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744

  • Orion Medical

    Houston, Texas, 77034

  • Heart Center Research Llc

    Huntsville, Alabama, 35801

  • UC San Diego Health

    La Jolla, California, 92037

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Icahn School of Med at Mt Sinai

    New York, New York, 10029

  • Midwest Heart and Vascular Spec

    Overland Park, Kansas, 66211

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • R Ins For Heart And Vascular Health

    Reno, Nevada, 89502

  • Reid Physician Associates

    Richmond, Indiana, 47374

  • Swedish Medical Center-Cardiovascular Research

    Seattle, Washington, 98122

  • Univ of Washington Medical Center

    Seattle, Washington, 98195

  • Cardio Metabolic Institute

    Somerset, New Jersey, 08873

  • Stanford Health Care

    Stanford, California, 94305

  • State Uni of NY at Stony Brook

    Stony Brook, New York, 11794-3362

  • Lundquist Inst BioMed at Harbor

    Torrance, California, 90509-2910

  • Westchester Medical Center

    Valhalla, New York, 10595

  • George Washington Univ Medical Ctr

    Washington D.C., District of Columbia, 20037

Other trials in United States

India8 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560069

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600081

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641009

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226003

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

  • Novartis Investigative Site

    New Delhi, 110025

Other trials in India

Spain8 sites

  • Novartis Investigative Site

    A Coruña, 15006

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    Valencia, 46010

Other trials in Spain

Belgium5 sites

  • Novartis Investigative Site

    Aalst, Oost Vlaanderen, 9300

  • Novartis Investigative Site

    Genk, Limburg, 3600

  • Novartis Investigative Site

    Hasselt, Limburg, 3500

  • Novartis Investigative Site

    Turnhout, Antwerpen, 2300

  • Novartis Investigative Site

    Yvoir, Namur, 5530

Other trials in Belgium

Australia4 sites

  • Novartis Investigative Site

    Auchenflower, Queensland, 4066

  • Novartis Investigative Site

    Chemside, Queensland, 4032

  • Novartis Investigative Site

    Leabrook, South Australia, 5068

  • Novartis Investigative Site

    Milton, Queensland, 4064

Other trials in Australia

China4 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100013

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Nanjing, Jiangsu, 211166

  • Novartis Investigative Site

    Shanghai, 200080

Other trials in China

France4 sites

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Poitiers, 86021

  • Novartis Investigative Site

    Toulouse, 31054

Other trials in France

Italy4 sites

  • Novartis Investigative Site

    Milan, MI, 20138

  • Novartis Investigative Site

    Milan, MI, 20157

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Torino, TO, 10126

Other trials in Italy

Japan4 sites

  • Novartis Investigative Site

    Izumisano, Osaka, 5988577

  • Novartis Investigative Site

    Kyoto, 6078062

  • Novartis Investigative Site

    Miyhazaki, Miyazaki, 8802102

  • Novartis Investigative Site

    Urasoe, Okinawa, 9012102

Other trials in Japan

South Korea4 sites

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620

  • Novartis Investigative Site

    Goyang-si, Gyeonggi-do, 10380

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 07804

Other trials in South Korea

Brazil3 sites

  • Novartis Investigative Site

    Curitiba, Paraná, 80040-050

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90560-032

  • Novartis Investigative Site

    São Paulo, 01409-902

Other trials in Brazil

Canada3 sites

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8

  • Novartis Investigative Site

    North York, Ontario, M6B 3H7

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

Argentina2 sites

  • Novartis Investigative Site

    Buenos Aires, C1428DCO

  • Novartis Investigative Site

    Caba, Buenos Aires, C1119ACN

Other trials in Argentina

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1083

  • Novartis Investigative Site

    Szeged, 6725

Other trials in Hungary

Ireland2 sites

  • Novartis Investigative Site

    Dublin, Ireland, D03 VX82

  • Novartis Investigative Site

    Galway, H91 YR71

Other trials in Ireland

Switzerland2 sites

  • Novartis Investigative Site

    Geneva, 1211

  • Novartis Investigative Site

    Lugano, 6900

Other trials in Switzerland

United Kingdom2 sites

  • Novartis Investigative Site

    Edinburgh, EH16 4SA

  • Novartis Investigative Site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

Other trials in United Kingdom

Chile1 site

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8380465

Other trials in Chile

About this study

Official title: 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.

Read the 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).

Being tested
Inclisiran sodium 300 mg, Placebo
Keywords
Inclisiran, KJX839, Atherosclerotic plaques, CCTA, CT-adapted Leaman score, LDL-C, FFRct, NOCAD, PCSK9 inhibitor, TAV
Medical subject headings
Coronary Artery Disease, Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inclisiran sodium 300 mgDrug

    Subcutaneously administered on Days 1, Month 3 (Day 90), and every 6 months thereafter.

  • PlaceboDrug

    Subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months thereafter.

Study groups in NCT05360446
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubcutaneous injection
Receives: Drug: Placebo
Inclisiran sodiumExperimentalSubcutaneous injection
Receives: Drug: Inclisiran sodium 300 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in total coronary atheroma volume

    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.

    Measured: From baseline to month 24

Secondary outcomes (3)

  1. Percentage change in LDL-C

    Full fasting lipid panel will be collected throughout the study beginning at baseline.

    Measured: From baseline to month 24

  2. Percentage change in low attenuation plaque volume evaluated by CCTA

    Evaluating inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA.

    Measured: From baseline to month 24

  3. Percentage of participants with progression, regression, or no change of total plaque atheroma volume

    Evaluating inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total atheroma volume.

    Measured: From baseline to month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start8 Jul 2022
  3. Primary completion26 Oct 2026 (estimated)
  4. Study completion27 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-center, randomized, double-blind, placebo-controlled, parallel-group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360446
Sponsor's protocol ID
CKJX839D12303
Other IDs
2021-004601-47
Acronym
V-PLAQUE
Status last verified
Oct 2026
First submitted
29 Apr 2022
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Revaiah PC, Serruys PW, Onuma Y, Andreini D, Budoff MJ, Sharif F, Chernofsky A, Vikarunnessa S, Wiethoff AJ, Yates D, Achouba A. Design and rationale of a randomized clinical trial assessing the effect of inclisiran on atherosclerotic plaque in individuals without previous cardiovascular event and without flow- limiting lesions identified in an in-hospital screening: The VICTORION-PLAQUE primary prevention trial. Am Heart J. 2026 Jan;291:199-212. doi: 10.1016/j.ahj.2025.08.001. Epub 2025 Aug 30.

    PubMed 40769373

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inclisiran sodium 300 mg in people with Coronary Artery Disease, run by Novartis Pharmaceuticals at 89 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, India, Spain, Belgium, Australia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in total coronary atheroma volume (time frame: From baseline to month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05360446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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