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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05739383




Registration number
NCT05739383
Ethics application status
Date submitted
13/02/2023
Date registered
22/02/2023
Date last updated
18/06/2024

Titles & IDs
Public title
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Scientific title
A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)
Secondary ID [1] 0 0
CKJX839D12302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Prevention of Atherosclerotic Cardiovascular Disease 0 0
Condition category
Condition code
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 (equivalent to 284 mg inclisiran) in 1.5 mL
Treatment: Drugs - Placebo in 1.5ml

Experimental: Inclisiran sodium 300mg - Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe.

Randomized in a 1:1 ratio with matching placebo

Placebo comparator: Placebo - Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.


Treatment: Drugs: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Subcutaneous injection in pre-filled syringe.

Treatment: Drugs: Placebo in 1.5ml
Matching placebo in 1.5ml solution for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to the first occurrence of 4P-MACE
Timepoint [1] 0 0
Time to the first occurrence of 4P-MACE (up to approximately 75 months)
Secondary outcome [1] 0 0
Time to the first occurrence of 3P-MACE
Timepoint [1] 0 0
Time to the first occurrence of 3P-MACE (up to approximately 75 months)
Secondary outcome [2] 0 0
Total number of first or repeated CV events (4P MACE)
Timepoint [2] 0 0
up to 75 months
Secondary outcome [3] 0 0
Total number of first or repeated CV events (3P MACE)
Timepoint [3] 0 0
up to 75 months
Secondary outcome [4] 0 0
Time to occurrence of Cardiovascular death
Timepoint [4] 0 0
Time to Cardiovascular death (up to 75 months)
Secondary outcome [5] 0 0
Time to occurrence of death due to any reason
Timepoint [5] 0 0
Time to all-cause mortality (up to 75 months)

Eligibility
Key inclusion criteria
* At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:

1. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis =20% but <50% in the left main coronary artery or stenosis =20% but <70% in any other major epicardial coronary artery, or
2. Coronary artery calcium (CAC) score obtained by CT-scan =100 Agatston units, or
3. High 10-year ASCVD risk =20%, or
4. Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
* LDL-C =70 mg/dL (=1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
Minimum age
40 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of major ASCVD event.
* History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
* Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
* Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
* Active liver disease or hepatic dysfunction
* Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
* Pregnant or nursing (lactating) women
* Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Prevention
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 assessing the outcomes
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
9/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/04/2029
Actual
Sample size
Target
14000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Canberra
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Novartis Investigative Site - Camperdown
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Novartis Investigative Site - Concord
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Novartis Investigative Site - Auchenflower
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Novartis Investigative Site - Clayton
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Novartis Investigative Site - Heidelberg Heights
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Novartis Investigative Site - Malvern East
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Novartis Investigative Site - Murdoch
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2605 - Canberra
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2050 - Camperdown
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2139 - Concord
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
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4556 - Sippy Downs
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4102 - Woolloongabba
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5000 - Adelaide
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5068 - Leabrook
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7000 - Hobart
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3168 - Clayton
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3081 - Heidelberg Heights
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3145 - Malvern East
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6150 - Murdoch
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Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Trial website
https://clinicaltrials.gov/study/NCT05739383
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/study/NCT05739383