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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05360446
Ethics application status
Date submitted
29/04/2022
Date registered
4/05/2022

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 (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.
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.
* 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 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
25/01/2027
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
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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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Pennsylvania
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Belgium
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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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Belgium
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Yvoir
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Brazil
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PR
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Brazil
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RS
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Brazil
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Sao Paulo
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Canada
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Ontario
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Canada
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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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China
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Shanghai
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France
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Paris 13
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France
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Paris
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France
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Pessac Cedex
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France
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Poitiers
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France
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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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Uttar Pradesh
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India
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Uttarakhand
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India
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West Bengal
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India
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Coimbatore
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India
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New Delhi
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Ireland
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Dublin
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Ireland
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Galway
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Italy
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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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Miyazaki
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Kyoto
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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
State/province [65] 0 0
Andalucia
Country [66] 0 0
Spain
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Castilla Y Leon
Country [67] 0 0
Spain
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Catalunya
Country [68] 0 0
Spain
State/province [68] 0 0
Comunidad Valenciana
Country [69] 0 0
Spain
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Galicia
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Geneve 14
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Switzerland
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Lugano
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United Kingdom
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Northern Ireland
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United Kingdom
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West Yorkshire
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United Kingdom
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Edinburgh
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United Kingdom
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London
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Newcastle upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05360446