Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
1/10/2024

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 (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 - Joondalup
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
6027 - Joondalup
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
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Belgium
State/province [23] 0 0
Aalst
Country [24] 0 0
Belgium
State/province [24] 0 0
Genk
Country [25] 0 0
Belgium
State/province [25] 0 0
Hasselt
Country [26] 0 0
Belgium
State/province [26] 0 0
Turnhout
Country [27] 0 0
Belgium
State/province [27] 0 0
Yvoir
Country [28] 0 0
Brazil
State/province [28] 0 0
PR
Country [29] 0 0
Brazil
State/province [29] 0 0
RS
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Chile
State/province [33] 0 0
Region De La Araucania
Country [34] 0 0
Chile
State/province [34] 0 0
RM
Country [35] 0 0
China
State/province [35] 0 0
Jiangsu
Country [36] 0 0
China
State/province [36] 0 0
Zhejiang
Country [37] 0 0
China
State/province [37] 0 0
Beijing
Country [38] 0 0
China
State/province [38] 0 0
Shanghai
Country [39] 0 0
France
State/province [39] 0 0
Paris 13
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Pessac Cedex
Country [42] 0 0
France
State/province [42] 0 0
Poitiers
Country [43] 0 0
France
State/province [43] 0 0
Toulouse 4
Country [44] 0 0
Hungary
State/province [44] 0 0
Budapest
Country [45] 0 0
Hungary
State/province [45] 0 0
Szeged
Country [46] 0 0
India
State/province [46] 0 0
Delhi
Country [47] 0 0
India
State/province [47] 0 0
Karnataka
Country [48] 0 0
India
State/province [48] 0 0
Tamil Nadu
Country [49] 0 0
India
State/province [49] 0 0
Uttar Pradesh
Country [50] 0 0
India
State/province [50] 0 0
Uttarakhand
Country [51] 0 0
India
State/province [51] 0 0
West Bengal
Country [52] 0 0
India
State/province [52] 0 0
Coimbatore
Country [53] 0 0
India
State/province [53] 0 0
New Delhi
Country [54] 0 0
Ireland
State/province [54] 0 0
Dublin
Country [55] 0 0
Ireland
State/province [55] 0 0
Galway
Country [56] 0 0
Italy
State/province [56] 0 0
MI
Country [57] 0 0
Italy
State/province [57] 0 0
TO
Country [58] 0 0
Japan
State/province [58] 0 0
Miyazaki
Country [59] 0 0
Japan
State/province [59] 0 0
Okinawa
Country [60] 0 0
Japan
State/province [60] 0 0
Osaka
Country [61] 0 0
Japan
State/province [61] 0 0
Kumamoto
Country [62] 0 0
Japan
State/province [62] 0 0
Kyoto
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Gyeonggi Do
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul
Country [65] 0 0
Spain
State/province [65] 0 0
Andalucia
Country [66] 0 0
Spain
State/province [66] 0 0
Castilla Y Leon
Country [67] 0 0
Spain
State/province [67] 0 0
Catalunya
Country [68] 0 0
Spain
State/province [68] 0 0
Comunidad Valenciana
Country [69] 0 0
Spain
State/province [69] 0 0
Galicia
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Switzerland
State/province [72] 0 0
Geneve 14
Country [73] 0 0
Switzerland
State/province [73] 0 0
Lugano
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Nothern Ireland
Country [75] 0 0
United Kingdom
State/province [75] 0 0
West Yorkshire
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Edinburgh
Country [77] 0 0
United Kingdom
State/province [77] 0 0
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
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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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