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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Duke University
Study ID
NCT06249165
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
130 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inclisiran
    Inclisiran + Usual Care
  • No Intervention: Usual Care
    Usual Care

Primary Outcome Measure

Achievement of LDL-C targets [ Time Frame: Day 360 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Univ. of Alabama - BirminghamBirminghamAlabama35205-
Univ. of California - IrvineOrangeCalifornia92868-
San Francisco General HospitalSan FranciscoCalifornia94110-
Emory UniversityAtlantaGeorgia30324-
Wellstar PauldingHiramGeorgia30141-
Rush UniversityChicagoIllinois60612-
University of IowaIowa CityIowa52242-
JHU - Suburban HospitalBethesdaMaryland20814-
Johns HopkinsColumbiaMaryland21044-
Essentia HealthDuluthMinnesota55805-
University of MissouriColumbiaMissouri65212-
Washington UniversitySt LouisMissouri63110-
University of NebraskaOmahaNebraska68198-
Heart House of NJHaddon HeightsNew Jersey08035-
University of North CarolinaChapel HillNorth Carolina27514-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake Forest UniversityWinston-SalemNorth Carolina27157-
Temple UniversityPhiladelphiaPennsylvania19140-
Medical Univ. of South CarolinaCharlestonSouth Carolina29403-
Houston MethodistHoustonTexas77030-
Baylor Scott & White - WacoWacoTexas76708-
University of UtahSalt Lake CityUtah84132-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Univ. of Alabama - Birmingham· Birmingham, ALUniv. of California - Irvine· Orange, CASan Francisco General Hospital· San Francisco, CAEmory University· Atlanta, GAWellstar Paulding· Hiram, GARush University· Chicago, IL

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