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Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease (VICTORION-2P)

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ClinicalTrials.gov Identifier: NCT05030428
Recruitment Status : Recruiting
First Posted : September 1, 2021
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Drug: Inclisiran sodium 300 mg Drug: Placebo Phase 3

Detailed Description:
Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, parallel group, placebo-controlled, multi-center, event-driven study
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : November 23, 2021
Estimated Primary Completion Date : January 4, 2027
Estimated Study Completion Date : March 15, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Inclisiran sodium
Subcutaneous injection
 Drug: Inclisiran sodium 300 mg
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
Placebo Comparator: Placebo
Subcutaneous injection
 Drug: Placebo
Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events) [ Time Frame: From randomization to total follow-up time (up to 72 months) ]
    3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.


Secondary Outcome Measures :
  1. Time to Occurrence of Cardiovascular (CV) Death [ Time Frame: From randomization to total follow-up time (up to 72 months) ]
    CV death is defined as death due to cardiovascular events

  2. Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events) [ Time Frame: From randomization to total follow-up time (up to 72 months) ]
    A composite 4P- MACE is defined as CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization.

  3. Time to occurrence of all-cause death [ Time Frame: From randomization to total follow-up time (up to 72 months) ]
    All-Cause death is defined as: all deaths from randomization until up to 72 months


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 coronary 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05030428


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05030428    
Other Study ID Numbers: CKJX839B12302
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Atherosclerotic cardiovascular disease
Hypercholesterolemia
Dyslipidemia
high cholesterol
 Hyperlipidemia
Inclisiran
siRNA
KJX839
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases