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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
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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)
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Secondary ID [1]
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2021-004601-47
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Secondary ID [2]
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CKJX839D12303
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Universal Trial Number (UTN)
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Trial acronym
V-PLAQUE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage change in total coronary atheroma volume
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Assessment method [1]
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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.
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Timepoint [1]
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From baseline to month 24
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Secondary outcome [1]
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Percentage change in LDL-C
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Assessment method [1]
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Full fasting lipid panel will be collected throughout the study beginning at baseline.
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Timepoint [1]
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From baseline to month 24
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Secondary outcome [2]
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Percentage change in low attenuation plaque volume evaluated by CCTA
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Assessment method [2]
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Evaluating inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA.
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Timepoint [2]
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From baseline to month 24
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Secondary outcome [3]
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Percentage of participants with progression, regression, or no change of total plaque atheroma volume
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Assessment method [3]
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Evaluating inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total atheroma volume.
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Timepoint [3]
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From baseline to month 24
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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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/01/2027
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Auchenflower
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Recruitment hospital [2]
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Novartis Investigative Site - Chemside
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Recruitment hospital [3]
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Novartis Investigative Site - Milton
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Novartis Investigative Site - Leabrook
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Novartis Investigative Site - Murdoch
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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4032 - Chemside
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4064 - Milton
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5068 - Leabrook
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05360446
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for public queries
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Novartis Pharmaceuticals
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Phone
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1-888-669-6682
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05360446
Download to PDF