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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/NCT05030428




Registration number
NCT05030428
Ethics application status
Date submitted
17/08/2021
Date registered
1/09/2021
Date last updated
10/06/2024

Titles & IDs
Public title
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)
Secondary ID [1] 0 0
CKJX839B12302
Universal Trial Number (UTN)
Trial acronym
VICTORION-2P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Treatment: Drugs - Placebo

Experimental: Inclisiran sodium - Subcutaneous injection

Placebo Comparator: Placebo - Subcutaneous injection


Treatment: Drugs: Inclisiran sodium 300 mg
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit

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

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
Timepoint [1] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [1] 0 0
Time to Occurrence of Cardiovascular (CV) Death
Timepoint [1] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [2] 0 0
Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)
Timepoint [2] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [3] 0 0
Time to first occurrence of Major Limb Adverse Events (MALE)
Timepoint [3] 0 0
From randomization to total follow-up time (up to 72 months)
Secondary outcome [4] 0 0
Time to occurrence of all-cause death
Timepoint [4] 0 0
From randomization to total follow-up time (up to 72 months)

Eligibility
Key inclusion criteria
1. Fasting LDL-C = 70 mg/dL at randomization visit

2. Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen
(including e.g. with or without Ezetimibe) that must include a high-intensity statin
therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin
greater than or equal to 20 mg QD

3. Established CV disease defined as ANY of the following three conditions

1. Spontaneous Myocardial infarction = 4 weeks from screening visit

2. History of ischemic stroke occurred = 4 weeks prior to the Screening visit

3. Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent
claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial
revascularization procedure, or, amputation due to atherosclerotic disease.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or
amputation due to atherosclerotic disease < 4 weeks before screening visit

2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or
planned use post first study visit

3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or
re-vascularization within the 6 months after the first study visit

4. Heart failure NYHA class III or IV

5. Active liver disease defined as any known current infectious, neoplastic, or metabolic
pathology of the liver

6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as
an investigational or marketed drug within 2 years

7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less
than 5 years

8. History of malignancy that required surgery radiation therapy and/or systemic therapy
during the 3 years prior to the first study visit

9. Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2027
Actual
Sample size
Target
Accrual to date
Final
17006
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Botany
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - New Lambton Heights
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Novartis Investigative Site - Auchenflower
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Novartis Investigative Site - Bundaberg West
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Novartis Investigative Site - Milton
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Novartis Investigative Site - Woolloongabba
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Novartis Investigative Site - Adelaide
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Novartis Investigative Site - Bedford Park
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Novartis Investigative Site - Leabrook
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Novartis Investigative Site - Woodville
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Novartis Investigative Site - Clayton
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Novartis Investigative Site - Geelong
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Novartis Investigative Site - Malvern East
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Novartis Investigative Site - Murdoch
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Novartis Investigative Site - Nedlands
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Novartis Investigative Site - Richmond
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4670 - Bundaberg West
Recruitment postcode(s) [6] 0 0
4064 - Milton
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4102 - Woolloongabba
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5000 - Adelaide
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5042 - Bedford Park
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5068 - Leabrook
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5011 - Woodville
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3168 - Clayton
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3220 - Geelong
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3145 - Malvern East
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
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6009 - Nedlands
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3121 - Richmond
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France
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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Coimbatore
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India
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India
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Israel
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Israel
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Israel
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Israel
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Israel
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Israel
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BS
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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SE
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Country [492] 0 0
Taiwan
State/province [492] 0 0
Taipei
Country [493] 0 0
Thailand
State/province [493] 0 0
Songkla
Country [494] 0 0
Thailand
State/province [494] 0 0
Bangkok
Country [495] 0 0
Thailand
State/province [495] 0 0
Chiang Mai
Country [496] 0 0
Thailand
State/province [496] 0 0
Muang
Country [497] 0 0
Turkey
State/province [497] 0 0
TUR
Country [498] 0 0
Turkey
State/province [498] 0 0
Adana
Country [499] 0 0
Turkey
State/province [499] 0 0
Ankara
Country [500] 0 0
Turkey
State/province [500] 0 0
Bursa
Country [501] 0 0
Turkey
State/province [501] 0 0
Cerrahpasa/Istanbul
Country [502] 0 0
Turkey
State/province [502] 0 0
Diskapi Ankara
Country [503] 0 0
Turkey
State/province [503] 0 0
Istanbul
Country [504] 0 0
Turkey
State/province [504] 0 0
Izmir
Country [505] 0 0
Turkey
State/province [505] 0 0
Konya

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

Ethics approval
Ethics application status

Summary
Brief summary
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on
major adverse cardiovascular (MACE) events in participants with established cardiovascular
disease (CVD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05030428
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries