A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04929249
Phase
PHASE3
Status
Completed

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

The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in an atherosclerotic cardiovascular disease (ASCVD) population.

Key Dates

Start date
Jun 25, 2021
Status verified
May 2025
Primary completion
Sep 15, 2023
Completion
Sep 15, 2023

Study Design

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

Arms

  • Experimental: Inclisiran First
    Inclisiran sodium 300 mg 1.5 ml (equivalent to 284 mg of inclisiran) + usual care
  • No Intervention: Usual Care
    Treating physicians were recommended to treat patients in accordance with the 2018 ACC/AHA guidelines

Primary Outcome Measure

Percent Change From Baseline in LDL-C [ Time Frame: Baseline, Day 330 ]

Locations (43)

FacilityCityStateZIPSite coordinators
ARcare Center for Clinical ResearchLittle RockArkansas72205-
ARcare Center for Clinical Research .Little RockArkansas72205-
Keck Medical Center USC .Los AngelesCalifornia90033-
d-b-a Greenwich Cardio Assoc CLCZ696BUS08GreenwichConnecticut06830-
Cardiology Ass of Fairfield County .StamfordConnecticut06905-
Integrative Research Associates IncFort LauderdaleFlorida33312-
Elite Cardiac Research Center .HialeahFlorida33012-
Jacksonville Ctr for Clin Rea Encore Research GroupJacksonvilleFlorida32216-
University of Florida Health Science Center .JacksonvilleFlorida32209-
Internal Medicine and CardiologyKissimmeeFlorida34741-
Gateway Cardiology PC CACZ885M2301_YounisJerseyvilleIllinois62052-
Affinity Health CorpOak BrookIllinois60523-
Northwestern Medicine Northwestern University .WinfieldIllinois60190-
Indiana University HealthIndianapolisIndiana46202-
St Elizabeth Healthcare .EdgewoodKentucky41017-
Alexandria Cardiology Clinic .AlexandriaLouisiana71301-
MedStar Good Samaritan HospitalBaltimoreMaryland21239-
Medstar Health Research Institute .BaltimoreMaryland21218-
Bryan LGH Heart Inst Intigrated Cardiology Group .LincolnNebraska68506-
Inspira Health Network The Heart HouseElmerNew Jersey08318-
New Jersey HeartLindenNew Jersey07036-
New York Presbyterian Queens .FlushingNew York11355-
New York Presbyterian Hospital .New YorkNew York10021-
State Uni of NY at Stony Brook .Stony BrookNew York11794-3362-
Montefiore Hospital .The BronxNew York10467 2490-
Milton S Hershey Medical CenterHersheyPennsylvania17033-
Capital Area ResearchNewportPennsylvania17074-
Capital Area Research LLC Suite 330NewportPennsylvania17074-
Cardiology Consultants of PhiladelphiaYardleyPennsylvania19067-
Alliance for Multispecialty Res LLCNashvilleTennessee37203-
Cypress Heart and Vascular CenterCypressTexas77429-
NW Houston Neuro Comp Sleep Med CtrCypressTexas77429-
Northwest Houston Cardiology PA .HoustonTexas77070-
Primecare Medical GroupHoustonTexas77024-
Synergy Group Medical LLCHoustonTexas77061-
Synergy Group Medical LLC .HoustonTexas77061-
Synergy Groups Medical LLCMissouri CityTexas77459-
Bay Area Heart Ace Clinical Resh Gp .WebsterTexas77598-
Centra Health .LynchburgVirginia24501-
National Clinical Research .RichmondVirginia23294-
Exemplar Research Inc .MorgantownWest Virginia26501-
Marshfield Medical Clinic .MarshfieldWisconsin54449-
Marshfield Clinic Health SystemWestonWisconsin54476-

Find similar trials in Little Rock, AR

By research site
ARcare Center for Clinical Research· Little Rock, ARARcare Center for Clinical Research .· Little Rock, ARKeck Medical Center USC .· Los Angeles, CAd-b-a Greenwich Cardio Assoc CLCZ696BUS08· Greenwich, CTCardiology Ass of Fairfield County .· Stamford, CTIntegrative Research Associates Inc· Fort Lauderdale, FL

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