Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT05581303
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo given by subcutaneous injection once every 12 weeks (Q12W).
  • Olpasiran — DRUG
    Olpasiran given by subcutaneous injection Q12W.

Study Details

The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

Key Dates

Start date
Dec 14, 2022
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
7,297 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo will be administered by subcutaneous injection.
  • Experimental: Olpasiran
    Olpasiran will be administered by subcutaneous injection.

Primary Outcome Measure

Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first [ Time Frame: Approximately 5 years ]

Locations (133)

FacilityCityStateZIPSite coordinators
Ascension Saint Vincents BirminghamBirminghamAlabama35211-
Grandview Medical Center Affinity Cardiovascular Specialists, LLCBirminghamAlabama35243-
Heart Center Research LLCHuntsvilleAlabama35801-
Mobile Heart Specialists PCMobileAlabama36608-
Alaska Cardiovascular Research FoundationAnchorageAlaska99508-
Elite Clinical Studies LLCPhoenixArizona85018-
HonorHealth Research and Innovation InstituteScottsdaleArizona85258-
National Heart InstituteBeverly HillsCalifornia90211-
Vitality Clinical ResearchBeverly HillsCalifornia90211-
University of California San DiegoLa JollaCalifornia92037-
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
University of California IrvineOrangeCalifornia92868-
University of California Los AngelesSanta MonicaCalifornia90404-
Manshadi Heart InstituteStocktonCalifornia95204-
Med Partners, Inc dba Premiere Medical Center, IncToluca LakeCalifornia91602-
UCHealth Memorial CentralColorado SpringsColorado80909-
Cardiology Associates of Fairfield County PCStamfordConnecticut06905-
MedStar Clinical ResearchWashington D.C.District of Columbia20010-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Bay Area CardiologyBrandonFlorida33511-
Clearwater Cardiovascular ConsultantsClearwaterFlorida33756-
Cardiology Associates Research LLCDaytona BeachFlorida32117-
Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine CareFort LauderdaleFlorida33312-
Elite Cardiac Research Center LLCHialeahFlorida33013-
East Coast Institute for Research LLCJacksonvilleFlorida32216-
East Coast Institute for Research, LLCJacksonvilleFlorida32204-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
University of FloridaJacksonvilleFlorida32209-
Westside Center for Clinical ResearchJacksonvilleFlorida32205-
Advanced Research for Health Improvement, LLCNaplesFlorida34102-
Ocala Cardiovascular ResearchOcalaFlorida34471-
AdventHealth Medical Group Cardiology at OrlandoOrlandoFlorida32803-
East Coast Institute for Research, LLCSaint AugustineFlorida32086-
Saint Johns Center for Clinical ResearchSaint AugustineFlorida32086-
Cardiovascular Center of SarasotaSarasotaFlorida34239-
Care Access - TampaTampaFlorida33625-
Morehouse School of MedicineAtlantaGeorgia30310-
Piedmont HealthcareAtlantaGeorgia30309-
Northeast Georgia Medical Center Wisteria BuildingCummingGeorgia30041-
NSC ResearchJohns CreekGeorgia30024-
St Lukes Idaho Cardiology AssociatesMeridianIdaho83642-
Northwest Heart Clinical Research LLCArlington HeightsIllinois60005-
Northshore University Health SystemEvanstonIllinois60201-
Advocate Lutheran General HospitalPark RidgeIllinois60068-
Cardiovascular Research of Northwest Indiana LLCMunsterIndiana46321-
Reid Physician AssociatesRichmondIndiana47374-
MercyOne Iowa Heart CenterWest Des MoinesIowa50266-
University of Kansas Medical CenterKansas CityKansas66160-
Midwest Heart and Vascular SpecialistsOverland ParkKansas66211-
Saint Elizabeth CovingtonCovingtonKentucky41011-
The Research Group of Lexington LLCLexingtonKentucky40503-
University of Louisville Health - Jewish HospitalLouisvilleKentucky40202-
Louisiana Heart CenterHammondLouisiana70403-
Care Access - Lake CharlesLake CharlesLouisiana70601-
Clinical Trials of America IncMonroeLouisiana71201-
Monroe Research LLCWest MonroeLouisiana71291-
Northern Light Eastern Maine Medical CenterBangorMaine04401-
Johns Hopkins University School of MedicineBaltimoreMaryland21287-
Maryland Cardiovascular SpecialistsBaltimoreMaryland21229-
University of Maryland Medical CenterBaltimoreMaryland21201-
Metropolitan Cardiovascular Consultants LLCBeltsvilleMaryland20705-
TidalHealth Peninsula Regional, IncSalisburyMaryland21804-
Brigham and Womens HospitalBostonMassachusetts02115-
Ascension Saint John HospitalDetroitMichigan48236-
Henry Ford HospitalDetroitMichigan48202-
Advanced Cardiology AssociatesGrand RapidsMichigan49546-
Healthy Heart CardiologyGrand RapidsMichigan49546-
Sparrow Clinical Research InstituteLansingMichigan48912-
Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research DivisionTroyMichigan48098-
Fairview Health ServicesMaplewoodMinnesota55109-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-
University of MinnesotaMinneapolisMinnesota55455-
Mayo Clinic RochesterRochesterMinnesota55902-
Cardiology Associates Research LLCTupeloMississippi38801-
Saint Louis Heart and Vascular PCSt LouisMissouri63136-
Bryan HeartLincolnNebraska68506-
Palm Research Center IncLas VegasNevada89128-
Renown Institute for Heart and Vascular HealthRenoNevada89502-
Saint Michaels Medical CenterNewarkNew Jersey07102-
Overlook Medical CenterSummitNew Jersey91010-
New York Presbyterian Medical Group Hudson Valley CardiologyCortlandt ManorNew York10567-
Elligo Health ResearchKew GardensNew York11415-
WMCHealth Heart and Vascular Institute Kingston Division of CardiologyKingstonNew York12401-
Northwell Health Physician Partners Cardiology at ManhassetManhassetNew York11030-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Icahn School of Medicine at Mount Sinai QueensNew YorkNew York10029-
New York University Langone HealthNew YorkNew York10016-
Northwell Health Lenox Hill Heart and VascularNew YorkNew York10022-
Northwell Health Physician Partners at PeconicRiverheadNew York11901-
Stony Brook University HospitalStony BrookNew York11794-
Westchester Medical CenterValhallaNew York10595-
NY Family DocsWoodhavenNew York11421-
Asheville Cardiology AssociatesAshevilleNorth Carolina28803-
Novant Health Heart and Vascular InstituteCharlotteNorth Carolina28204-
Duke UniversityDurhamNorth Carolina27710-
Moses H Cone Memorial HospitalGreensboroNorth Carolina27401-
Lapis Clinical ResearchMooresvilleNorth Carolina28117-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Lillestol Research LLCFargoNorth Dakota58104-
TriHealth Good Samaritan HospitalCincinnatiOhio45220-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The OhioHealth Research InstituteColumbusOhio43214-
Kettering Medical CenterKetteringOhio45429-
Rama Research LLCMarionOhio43302-
Oregon Health and Science UniversityPortlandOregon97239-
Capital Area Research LLCNewportPennsylvania17074-
Montefiore Medical Center - BronxPhiladelphiaPennsylvania19141-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Prisma Health Midlands CardiologyColumbiaSouth Carolina29203-
Piedmont Research PartnersFort MillSouth Carolina29707-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
Stern Cardiovascular Foundation IncGermantownTennessee38138-
Tennessee Center for Clinical TrialsTullahomaTennessee37388-
Texas Diabetes and EndocrinologyAustinTexas78731-
Baylor Scott and White Heart and Vascular Hospital-DallasDallasTexas75226-
Southwest Family Medicine AssociatesDallasTexas75235-
David Turbay, MDEl PasoTexas79905-
Care Access - GeorgetownGeorgetownTexas78633-
Baylor College of MedicineHoustonTexas77030-
Texas Cardiology Associates of HoustonKingwoodTexas77339-
Texas Institute of CardiologyMcKinneyTexas75071-
Permian Research FoundationOdessaTexas79761-
Northwest Houston Heart CenterTomballTexas77375-
Inova Heart and Vascular InstituteFairfaxVirginia22031-
Virginia HeartFalls ChurchVirginia22042-
Virginia Heart - LoudounLeesburgVirginia20176-
Carient Heart and VascularManassasVirginia20109-
Bon Secours CardiologyMidlothianVirginia23114-
Tidewater Physicians Multispecialty Group Clinical ResearchNewport NewsVirginia23606-
Winchester Cardiology and Vascular MedicineWinchesterVirginia22601-
Pulse Heart InstitutePuyallupWashington98372-

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