Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04873934
Phase
PHASE3
Status
Completed

Conditions

  • Acute Coronary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran — DRUG
    Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)

Study Details

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.

Key Dates

Start date
Jun 24, 2021
Status verified
Oct 2025
Primary completion
Aug 7, 2024
Completion
Aug 7, 2024

Study Design

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

Arms

  • Experimental: Inclisiran with Usual Care
    Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
  • No Intervention: Usual Care
    Usual Care Alone

Primary Outcome Measure

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

Locations (88)

FacilityCityStateZIPSite coordinators
Northeast Arkansas Baptist ClinicJonesboroArkansas72401-
Central Cardiology Medical CenterBakersfieldCalifornia93308-
The Heart Group Cardiovascular Associates IncFresnoCalifornia93720-
Mission Heritage Medical GroupMission ViejoCalifornia92691-
Northbay Clinical Research LLCSanta RosaCalifornia95405-
Clinnova Research SolutionsTorranceCalifornia90277-
Harbor-UCLA Medical CenterTorranceCalifornia90502-
Interv Cardiology Med GrpWest HillsCalifornia91307-
Aurora Denver Cardiology AssociatesAuroraColorado80012-
Colorado Springs CardiologyColorado SpringsColorado80907-
Colorado Heart and VascularLakewoodColorado80228-
Cardiology Ass of Fairfield CountyStamfordConnecticut06905-
George Washington Univ Medical CtrWashington D.C.District of Columbia20037-
Washington Hospital CenterWashington D.C.District of Columbia20010-
Nova Clinical Research LLCBradentonFlorida34209-
Teradan Clinical trials LLCBrandonFlorida33511-
Clearwater Cardiovascular and Interventional ConsultantsClearwaterFlorida33756-
Cardiology Research AssociatesDaytona BeachFlorida32117-
Holy Cross Hospital IncFort LauderdaleFlorida33308-
Baptist Health Research InstituteJacksonvilleFlorida32207-
Reliant Medical ResearchMiamiFlorida33165-
Inpatient Research Clinical LLCMiami LakesFlorida33014-
Innovation Medical Group LLCPalmetto BayFlorida33157-
Cardiology ConsultantsPensacolaFlorida32501-
Theia Clinical Research Ctrs LLCTampaFlorida33613-
Ellipsis GroupAtlantaGeorgia30342-
Emory UniversityAtlantaGeorgia30322-
Morehouse School Of MedicineAtlantaGeorgia30310-
Northside HospitalAtlantaGeorgia30342-
Northwest Heart Clinical Rsrch LLCArlington HeightsIllinois60005-
AMITA Heart and Vascular GroupHinsdaleIllinois60521-
Franciscan Health Services Research CenterIndianapolisIndiana46237-
Cardiovascular Research Of Northwest Indiana, LlcMunsterIndiana46321-
Iowa Heart CenterDes MoinesIowa50314-
Midwest Heart and Vascular SpecOverland ParkKansas66211-
Tidal Health Peninsula Regional IncSalisburyMaryland21804-
Sparrow Clincal Research InstituteLansingMichigan48912-
MidMichigan Physicians GroupMidlandMichigan48640-
St Marys of Ascension ResearchSaginawMichigan48601-
Trinity Health Michigan HeartYpsilantiMichigan48197-
Minneapolis Heart InstituteMinneapolisMinnesota55407-
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303-
Jackson Heart ClinicJacksonMississippi39216-
Cardiology Associates of North MSTupeloMississippi38801-
St Louis Heart and VascularSt LouisMissouri63136-
Bryan LGH Heart Inst Intigrated Cardiology GroupLincolnNebraska68506-
Meridian Clinical ResearchLincolnNebraska68506-
Advanced Heart Care, LLCBridgewaterNew Jersey08807-
Cardiovas Assoc of Delaware ValleyElmerNew Jersey08318-
Inspira Medical Cent Mullica HillMullica HillNew Jersey08062-
Capital Cardiology AssociatesAlbanyNew York12211-
University At BuffaloBuffaloNew York14203-
Bassett Medical CenterCooperstownNew York13326-
Jamaica Hospital Medical CenterJamaicaNew York11418-
Northwell HealthManhassetNew York11030-
Laurelton Heart Specialist PCRosedaleNew York11422-
Cary Research GroupCaryNorth Carolina27511-
Moses Cone Hospital-Lebauer CV Research FoundationGreensboroNorth Carolina27403-
Clinical Trials Of America LLCLenoirNorth Carolina28645-
Pinehurst Medical ClinicPinehurstNorth Carolina28374-
Wake Forest University Baptist Medical CenterWinston-SalemNorth Carolina27157-
Aultman HospitalCantonOhio44710-
University of ToledoToledoOhio43614-
St John Health SystemBartlesvilleOklahoma74006-
Bend Memorial ClinicBendOregon97701-
University of Pittsburgh Medical Center HABOTEriePennsylvania16550-
Lancaster General HealthLancasterPennsylvania17602-
Allegheny General HospitalPittsburghPennsylvania15212-
Guthrie ClinicSayrePennsylvania18840-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
Covenant Medical GroupKnoxvilleTennessee37916-
Baylor Scott and White Heart and Vascular HospitalDallasTexas75226-
Northwest Houston Cardiology PAHoustonTexas77070-
Texas Heart Medical GroupHoustonTexas77030-
UT Physicians Memorial HermannHoustonTexas77030-
Vilo Research Group LLCHoustonTexas77017-
West Houston Area Clinical Trial ConsultantsHoustonTexas77094-
The Heart Institute of East TexasLufkinTexas75904-
CardioVoyage LLCMcKinneyTexas75071-
Research Group of North TexasSunnyvaleTexas75182-
Tyler Cardiovascular ConsultantsTylerTexas75701-
Intermountain Medical CenterMurrayUtah84107-
TPMG Clinical ResearchNewport NewsVirginia23608-
York Clinical ResearchNorfolkVirginia23504-
Dominion Medical AssociatesRichmondVirginia23219-
Carilion ClinicRoanokeVirginia24013-
Selma Medical AssociatesWinchesterVirginia22601-
MultiCare Institute for Research and InnovationTacomaWashington98405-

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Northeast Arkansas Baptist Clinic· Jonesboro, ARCentral Cardiology Medical Center· Bakersfield, CAThe Heart Group Cardiovascular Associates Inc· Fresno, CAMission Heritage Medical Group· Mission Viejo, CANorthbay Clinical Research LLC· Santa Rosa, CAClinnova Research Solutions· Torrance, CA

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