VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
NCT ID: NCT06249165
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
130 participants
INTERVENTIONAL
2024-12-16
2027-02-28
Brief Summary
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Detailed Description
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The study funder made a business decision to close the study to enrollment. Any patients identified and confirmed eligible prior to May 30, 2025 were permitted to be randomized through June 6, 2025. A total of 130 participants were enrolled. Participants randomized to Inclisiran + Usual Care will complete the study as originally planned. Participants randomized to Usual Care alone will have the option to receive inclisiran earlier if they choose to do so. They may also opt to complete only the Usual Care portion of the study (i.e., never receive study inclisiran) or to withdraw from the study. Usual Care participants will be required to sign an addendum to consent to these changes and identify their selection.
The study population will consist of underrepresented and historically understudied male and female participants (targeting 50% female, 70% underrepresented \[Black/African American, Hispanic/Latino, Asian, other\] and 10% rural participants of any sex or race/ethnicity) ≥18 years of age with a history of ASCVD (coronary artery disease, ischemic cerebrovascular disease or peripheral arterial disease) or ASCVD risk equivalent (HeFH, Type 2 DM, or 10 year ASCVD risk score ≥ 20%) who have elevated LDL-C (≥ 70 mg/dL or LDL-C ≥ 100 mg/dL) respectively) despite being treated with statin therapy. A total of approximately 1440 participants will be randomized to inclisiran + usual care or usual care in a 1:1 ratio at up to 30 US healthcare systems.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inclisiran
Inclisiran + Usual Care
Inclisiran
Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).
Usual Care
Usual Care
No interventions assigned to this group
Interventions
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Inclisiran
Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
3. Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy.
4. Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
5. On statin therapy, or have documented statin intolerance, as determined by the treating clinician. Participants for whom statin therapy has been recently initiated must be on stable therapy for at least 4 weeks and subsequent LDL-C must be above the threshold.
6. From historically underrepresented populations in cardiovascular clinical research, including at least one of the following: female sex; Hispanic/Latino ethnicity; Black/African-American, Asian, or Native American race; rural dwelling based on the HRSA definition for determining rural grant eligibility using the Federal Office of Rural Health Policy (FORHP) 2010 County and Census Tract file.
Exclusion Criteria
2. Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening.
3. History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
6. New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \<25%.
7. Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or other methods (i.e. via ablation etc.) at the time of pre-screening. Controlled arrhythmia is not an exclusion.
8. Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.
9. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or alanine aminotransferase (ALT) elevation \>3x ULN, aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \>2x ULN (except participants with Gilbert's syndrome) at pre-screening confirmed by a repeat measurement at least one week apart. Lack of repeat measurement is not considered an exclusion.
10. End-stage renal disease (ESRD), defined as being on dialysis of any kind.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Neha Pagidipati, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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Univ. of Alabama - Birmingham
Birmingham, Alabama, United States
Univ. of California - Irvine
Orange, California, United States
San Francisco General Hospital
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Wellstar Paulding
Hiram, Georgia, United States
Rush University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
JHU - Suburban Hospital
Bethesda, Maryland, United States
Johns Hopkins
Columbia, Maryland, United States
Essentia Health
Duluth, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Heart House of NJ
Haddon Heights, New Jersey, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Temple University
Philadelphia, Pennsylvania, United States
Medical Univ. of South Carolina
Charleston, South Carolina, United States
Houston Methodist
Houston, Texas, United States
Baylor Scott & White - Waco
Waco, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CKJX839A1US10
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00115658
Identifier Type: -
Identifier Source: org_study_id