VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease

NCT06249165 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: Pro00115658CKJX839A1US10
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 23

Brief Summary

VictORION-INCLUSION (V-INCLUSION) seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

Hyperlipidemia; Secondary Cardiovascular Prevention; Primary Prevention; Atherosclerotic Cardiovascular Disease (ASCVD); Hypercholesterolemia; Lipid lowering therapies; Inclisiran

Outcome Measures

Primary Outcomes (1)

• Achievement of LDL-C targets

  Achieving LDL-C targets (LDL-C \< 70 mg/dL for ASCVD participants or LDL-C \< 100 for ASCVD risk equivalent participants) (yes/no)

  Day 360

Secondary Outcomes (4)

• Achievement of LDL-C targets by subgroup

  Day 360

• Change in LDL-C from baseline by population

  Day 360

• Achievement of LDL-C targets by population

  Day 360

• Safety and tolerability of inclisiran

  Through study completion, up to approximately 630 days

Study Arms (2)

Inclisiran

EXPERIMENTAL

Inclisiran + Usual Care

Drug: Inclisiran

Usual Care

NO INTERVENTION

Usual Care

Interventions

Inclisiran DRUG

Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).

Also known as: Leqvio

Inclisiran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females \>= 18 years of age
• Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
• 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.
• Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
• 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.
• 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.

You may not qualify if:

• Planned use of other investigational products or devices during the course of the study.
• Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening.
• History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
• Pregnant or nursing (lactating) women.
• 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.
• New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \<25%.
• Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.
• End-stage renal disease (ESRD), defined as being on dialysis of any kind.

Sponsors & Collaborators

• Duke University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (23)

Univ. of Alabama - Birmingham

Birmingham, Alabama, 35205, United States

Location

Univ. of California - Irvine

Orange, California, 92868, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Emory University

Atlanta, Georgia, 30324, United States

Location

Wellstar Paulding

Hiram, Georgia, 30141, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

JHU - Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Johns Hopkins

Columbia, Maryland, 21044, United States

Location

Essentia Health

Duluth, Minnesota, 55805, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Heart House of NJ

Haddon Heights, New Jersey, 08035, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Medical Univ. of South Carolina

Charleston, South Carolina, 29403, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Baylor Scott & White - Waco

Waco, Texas, 76708, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Hyperlipidemias; Hypercholesterolemia

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Neha Pagidipati, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled, multicenter, open-label two arm trial

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)