"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)"

PHASE3CompletedINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

June 25, 2021

Primary Completion Date

September 15, 2023

Study Completion Date

September 15, 2023

Conditions
Atherosclerotic Cardiovascular Disease
Interventions
DRUG

Inclisiran

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

Trial Locations (43)

10021

New York Presbyterian Hospital ., New York

11355

New York Presbyterian Queens ., Flushing

17033

Milton S Hershey Medical Center, Hershey

17074

Capital Area Research LLC Suite 330, Newport

Capital Area Research, Newport

19067

Cardiology Consultants of Philadelphia, Yardley

21218

Medstar Health Research Institute ., Baltimore

21239

MedStar Good Samaritan Hospital, Baltimore

23294

National Clinical Research ., Richmond

24501

Centra Health ., Lynchburg

26501

Exemplar Research Inc ., Morgantown

32209

University of Florida Health Science Center ., Jacksonville

32216

Jacksonville Ctr for Clin Rea Encore Research Group, Jacksonville

33012

Elite Cardiac Research Center ., Hialeah

33312

Integrative Research Associates Inc, Fort Lauderdale

34741

Internal Medicine and Cardiology, Kissimmee

37203

Alliance for Multispecialty Res LLC, Nashville

41017

St Elizabeth Healthcare ., Edgewood

46202

Indiana University Health, Indianapolis

54449

Marshfield Medical Clinic ., Marshfield

54476

Marshfield Clinic Health System, Weston

60190

Northwestern Medicine Northwestern University ., Winfield

60523

Affinity Health Corp, Oak Brook

62052

Gateway Cardiology PC CACZ885M2301_Younis, Jerseyville

68506

Bryan LGH Heart Inst Intigrated Cardiology Group ., Lincoln

71301

Alexandria Cardiology Clinic ., Alexandria

72205

ARcare Center for Clinical Research ., Little Rock

ARcare Center for Clinical Research, Little Rock

77024

Primecare Medical Group, Houston

77061

Synergy Group Medical LLC ., Houston

Synergy Group Medical LLC, Houston

77070

Northwest Houston Cardiology PA ., Houston

77429

Cypress Heart and Vascular Center, Cypress

NW Houston Neuro Comp Sleep Med Ctr, Cypress

77459

Synergy Groups Medical LLC, Missouri City

77598

Bay Area Heart Ace Clinical Resh Gp ., Webster

90033

Keck Medical Center USC ., Los Angeles

06830

d-b-a Greenwich Cardio Assoc CLCZ696BUS08, Greenwich

06905

Cardiology Ass of Fairfield County ., Stamford

08318

Inspira Health Network The Heart House, Elmer

07036

New Jersey Heart, Linden

11794-3362

State Uni of NY at Stony Brook ., Stony Brook

10467 2490

Montefiore Hospital ., The Bronx

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY