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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05360446




Registration number
NCT05360446
Ethics application status
Date submitted
29/04/2022
Date registered
4/05/2022
Date last updated
5/04/2024

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
2021-004601-47
Secondary ID [2] 0 0
CKJX839D12303
Universal Trial Number (UTN)
Trial acronym
V-PLAQUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Inclisiran sodium 300 mg
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Subcutaneous injection

Experimental: Inclisiran sodium - Subcutaneous injection


Treatment: Drugs: Inclisiran sodium 300 mg
Subcutaneously administered on Days 1, Month 3 (Day 90), and every 6 months thereafter.

Treatment: Drugs: Placebo
Subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months thereafter.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change in total coronary atheroma volume
Timepoint [1] 0 0
From baseline to month 24
Secondary outcome [1] 0 0
Percentage change in LDL-C
Timepoint [1] 0 0
From baseline to month 24
Secondary outcome [2] 0 0
Percentage change in low attenuation plaque volume evaluated by CCTA
Timepoint [2] 0 0
From baseline to month 24
Secondary outcome [3] 0 0
Percentage of participants with progression, regression, or no change of total plaque atheroma volume
Timepoint [3] 0 0
From baseline to month 24

Eligibility
Key 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 if on
statin therapy but not on a maximally tolerated statin therapy; ii) =150 mg/dL if
statin naive and without documented statin intolerance; or iii) =70 mg/dL if on a
stable (=4 weeks) dose of maximally tolerated statin therapy or if statin intolerant.

- Participants may be pre-identified based on a CCTA or an invasive angiography that is
performed as part of standard of care within 12 months prior to the participant's
Screening Visit demonstrating:

- Presence of coronary artery plaque with visual diameter stenosis <50% or

- Coronary artery plaque with visual artery stenosis >50% but Fractional Flow Reserve
(FFR) >0.8 by special wire measurement (CCTA or coronary angiography)

- Fasting LDL-C local lab value =70 mg/dL at the assessment performed during the Statin
Optimization Period 3 Visit for participants going through the Statin Optimization
Period.

- Participants having Non-Obstructive Coronary Artery (NOCA)* confirmed by CCTA with
FFRct >0.8 and CT-adapted Leaman score >5** or coronary artery plaque with visual
diameter stenosis >50% but with FFRct >0.8 and CT-adapted Leaman score >5 without
previous cardiovascular events.

*=NOCA is defined as the presence of coronary artery plaque with visual diameter
stenosis <50%.

**=CT-adapted Leaman score, which includes information on lesion localization, plaque
composition, degree of stenosis by CCTA is demonstrated to be an independent long-term
predictor of hard cardiac events.

- 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

- NOCA participant who was prescreened by the Investigator with visual diameter stenosis
>50% but FFR <0.8.

- 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. Participants who enter the Statin
Optimization Period must have AST and ALT =3x ULN (as defined by local laboratory
reference ranges collected at the Screening Visit) and reported by the Statin
Optimization Telephone Visit 1 to be allowed to continue in the Statin Optimization
Period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/01/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Auchenflower
Recruitment hospital [2] 0 0
Novartis Investigative Site - Chemside
Recruitment hospital [3] 0 0
Novartis Investigative Site - Milton
Recruitment hospital [4] 0 0
Novartis Investigative Site - Leabrook
Recruitment hospital [5] 0 0
Novartis Investigative Site - Murdoch
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4032 - Chemside
Recruitment postcode(s) [3] 0 0
4064 - Milton
Recruitment postcode(s) [4] 0 0
5068 - Leabrook
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
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California
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Connecticut
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District of Columbia
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Florida
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Illinois
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Indiana
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Kansas
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United States of America
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Kentucky
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Maryland
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Minnesota
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Nevada
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New Jersey
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New York
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Ohio
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Oregon
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Washington
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Argentina
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Buenos Aires
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Aalst
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Belgium
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Genk
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Belgium
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Hasselt
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Belgium
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Turnhout
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Yvoir
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Brazil
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PR
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RS
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Sao Paulo
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Ontario
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Quebec
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Chile
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Region De La Araucania
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Chile
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RM
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China
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Jiangsu
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China
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Zhejiang
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China
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Beijing
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Paris 13
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Paris
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Poitiers
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Toulouse 4
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Hungary
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Budapest
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Hungary
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Szeged
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India
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Delhi
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India
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Karnataka
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India
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Tamil Nadu
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India
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Uttarakhand
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West Bengal
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India
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Coimbatore
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Dublin
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Galway
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MI
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Italy
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TO
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Miyazaki
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Japan
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Okinawa
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Osaka
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Korea, Republic of
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Gyeonggi Do
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Korea, Republic of
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Seoul
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Spain
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Andalucia
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Castilla Y Leon
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Catalunya
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Comunidad Valenciana
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Galicia
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Barcelona
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Geneve 14
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Switzerland
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Lugano
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Northern Ireland
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West Yorkshire
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Edinburgh
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London
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United Kingdom
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Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05360446
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05360446