Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT01764633
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Evolocumab — BIOLOGICAL
    Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
  • Placebo — DRUG
    Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Study Details

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

Key Dates

Start date
Feb 8, 2013
Status verified
May 2024
Primary completion
Nov 11, 2016
Completion
Nov 11, 2016

Study Design

Enrollment
27,564 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
  • Experimental: Evolocumab
    Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.

Primary Outcome Measure

Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

Locations (326)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35235-
Research SiteBirminghamAlabama35294-
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteAnchorageAlaska99508-
Research SiteGlendaleArizona85306-
Research SitePhoenixArizona85015-
Research SitePhoenixArizona85018-
Research SitePhoenixArizona85054-
Research SiteTucsonArizona85712-
Research SiteTucsonArizona85723-
Research SiteAlhambraCalifornia91801-
Research SiteBanningCalifornia92220-
Research SiteBeverly HillsCalifornia90211-
Research SiteEncinoCalifornia91436-
Research SiteEscondidoCalifornia92029-
Research SiteGlendaleCalifornia91204-
Research SiteHarbor CityCalifornia90710-
Research SiteHuntington BeachCalifornia92646-
Research SiteLaguna HillsCalifornia92653-
Research SiteLong BeachCalifornia90807-
Research SiteLong BeachCalifornia90822-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90033-
Research SiteLos AngelesCalifornia90048-
Research SiteNewport BeachCalifornia92663-
Research SiteOceansideCalifornia92056-
Research SiteOxnardCalifornia93030-
Research SitePalm SpringsCalifornia92262-
Research SiteRosevilleCalifornia95661-
Research SiteSacramentoCalifornia95816-
Research SiteSan DiegoCalifornia92103-
Research SiteSan DiegoCalifornia92161-
Research SiteSan PedroCalifornia90732-
Research SiteSanta AnaCalifornia92704-
Research SiteTarzanaCalifornia91356-
Research SiteThousand OaksCalifornia91360-
Research SiteTorranceCalifornia90502-
Research SiteTorranceCalifornia90503-
Research SiteValley VillageCalifornia91607-
Research SiteAuroraColorado80012-
Research SiteColorado SpringsColorado80907-
Research SiteColorado SpringsColorado80909-
Research SiteDenverColorado80218-
Research SiteGreeleyColorado80631-
Research SiteLittletonColorado80120-
Research SiteLongmontColorado80501-
Research SiteBridgeportConnecticut06610-
Research SiteNewarkDelaware19718-
Research SiteSeafordDelaware19973-
Research SiteWilmingtonDelaware19803-
Research SiteWashington D.C.District of Columbia20037-
Research SiteAtlantisFlorida33462-
Research SiteAventuraFlorida33180-
Research SiteBay PinesFlorida33744-
Research SiteBoynton BeachFlorida33472-
Research SiteBradentonFlorida34205-
Research SiteClearwaterFlorida33756-
Research SiteCrystal RiverFlorida34429-
Research SiteDaytona BeachFlorida32117-
Research SiteDeerfield BeachFlorida33442-
Research SiteDelray BeachFlorida33484-
Research SiteEdgewaterFlorida32141-
Research SiteFleming IslandFlorida32003-
Research SiteFort LauderdaleFlorida33308-
Research SiteHollywoodFlorida33021-
Research SiteJacksonvilleFlorida32216-
Research SiteJacksonville BeachFlorida32250-
Research SiteLakelandFlorida33805-
Research SiteLargoFlorida33777-
Research SiteMelbourneFlorida32901-
Research SiteMiamiFlorida33144-
Research SiteMiamiFlorida33155-
Research SiteMiamiFlorida33173-
Research SiteNew Port RicheyFlorida34653-
Research SiteOrlandoFlorida32806-
Research SitePalm HarborFlorida34684-
Research SitePembroke PinesFlorida33024-
Research SitePembroke PinesFlorida33028-
Research SitePensacolaFlorida32501-
Research SitePonte VedraFlorida32081-
Research SitePort CharlotteFlorida33952-
Research SiteSafety HarborFlorida34695-
Research SiteSanfordFlorida32771-
Research SiteSarasotaFlorida34232-
Research SiteSarasotaFlorida34239-
Research SiteSt. PetersburgFlorida33709-
Research SiteSt. PetersburgFlorida33713-
Research SiteTampaFlorida33614-
Research SiteWellingtonFlorida33449-
Research SiteWest Palm BeachFlorida33401-
Research SiteAthensGeorgia30606-
Research SiteAtlantaGeorgia30342-
Research SiteAugustaGeorgia30909-
Research SiteDunwoodyGeorgia30338-
Research SiteEast PointGeorgia30344-
Research SiteEatontonGeorgia31024-
Research SiteGainesvilleGeorgia30501-
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Research SiteAddisonIllinois60101-
Research SiteBellevilleIllinois62220-
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Research SiteHazel CrestIllinois60429-
Research SiteJerseyvilleIllinois62052-
Research SiteQuincyIllinois62301-
Research SiteEvansvilleIndiana47714-
Research SiteIndianapolisIndiana46227-
Research SiteIndianapolisIndiana46237-
Research SiteIndianapolisIndiana46260-
Research SiteMunsterIndiana46321-
Research SiteValparaisoIndiana46383-
Research SiteAmesIowa50010-
Research SiteDes MoinesIowa50266-
Research SiteIowa CityIowa52242-
Research SiteWaterlooIowa50702-
Research SiteHutchinsonKansas67502-
Research SiteKansas CityKansas66160-
Research SiteOverland ParkKansas66210-
Research SiteWichitaKansas67203-
Research SiteWichitaKansas67214-
Research SiteLexingtonKentucky40504-
Research SiteOwensboroKentucky42303-
Research SiteBaton RougeLouisiana70808-
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Research SiteHammondLouisiana70403-
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Research SiteMetairieLouisiana70006-
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Research SitePortlandMaine04101-
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Research SiteBaltimoreMaryland21237-
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Research SiteColumbiaMaryland21044-
Research SiteColumbiaMaryland21045-
Research SiteHollywoodMaryland20636-
Research SiteSalisburyMaryland21804-
Research SiteTowsonMaryland21204-
Research SiteAyerMassachusetts01432-
Research SiteBillericaMassachusetts01821-
Research SiteFall RiverMassachusetts02720-
Research SiteHaverhillMassachusetts01830-
Research SiteHyannisMassachusetts02601-
Research SiteNewtonMassachusetts02459-
Research SiteQuincyMassachusetts02169-
Research SiteSpringfieldMassachusetts01199-
Research SiteWatertownMassachusetts02472-
Research SiteAnn ArborMichigan48106-
Research SiteDearbornMichigan48124-
Research SiteFlintMichigan48532-
Research SiteGrandvilleMichigan49418-
Research SiteLansingMichigan48912-
Research SiteMuskegonMichigan49444-
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Research SiteSaginawMichigan48604-
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Research SiteColumbiaMissouri65212-
Research SiteJefferson CityMissouri65109-
Research SiteKansas CityMissouri64128-
Research SiteSt LouisMissouri63117-
Research SiteSt LouisMissouri63128-
Research SiteBillingsMontana59101-
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Research SiteGreat FallsMontana59405-
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Research SiteNew YorkNew York10036-
Research SiteRochesterNew York14609-
Research SiteStony BrookNew York11794-
Research SiteSyracuseNew York13202-
Research SiteTroyNew York12180-
Research SiteWest SenecaNew York14224-
Research SiteWilliamsvilleNew York14221-
Research SiteAshevilleNorth Carolina28801-
Research SiteAshevilleNorth Carolina28805-
Research SiteCalabashNorth Carolina28467-
Research SiteCaryNorth Carolina27518-
Research SiteCharlotteNorth Carolina28204-
Research SiteCharlotteNorth Carolina28277-
Research SiteDurhamNorth Carolina27710-
Research SiteGreensboroNorth Carolina27408-
Research SiteHickoryNorth Carolina28601-
Research SiteHigh PointNorth Carolina27262-
Research SiteLenoirNorth Carolina28645-
Research SiteMooresvilleNorth Carolina28117-
Research SiteRaleighNorth Carolina27609-
Research SiteStatesvilleNorth Carolina28625-
Research SiteTabor CityNorth Carolina28463-
Research SiteWilmingtonNorth Carolina28401-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteWinston-SalemNorth Carolina27127-
Research SiteFargoNorth Dakota58122-
Research SiteGrand ForksNorth Dakota58201-
Research SiteCantonOhio44710-
Research SiteCincinnatiOhio45219-
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Research SiteClevelandOhio44195-
Research SiteColumbusOhio43201-
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Research SiteDaytonOhio45414-
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Research SiteWestlakeOhio44145-
Research SiteWilloughbyOhio44094-
Research SiteOklahoma CityOklahoma73135-
Research SitePryorOklahoma74362-
Research SiteTulsaOklahoma74133-
Research SiteBendOregon97701-
Research SitePortlandOregon97225-
Research SitePortlandOregon97239-
Research SiteAbingtonPennsylvania19001-
Research SiteAltoonaPennsylvania16602-
Research SiteCamp HillPennsylvania17011-
Research SiteChambersburgPennsylvania17201-
Research SiteFeastervillePennsylvania19053-
Research SiteIndianaPennsylvania15701-
Research SiteJersey ShorePennsylvania17740-
Research SiteNorristownPennsylvania19401-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19107-
Research SitePhiladelphiaPennsylvania19152-
Research SitePittsburghPennsylvania15206-
Research SiteSellersvillePennsylvania18960-
Research SiteUniontownPennsylvania15401-
Research SiteYorkPennsylvania17405-
Research SiteCranstonRhode Island02920-
Research SiteCumberlandRhode Island02864-
Research SiteJohnstonRhode Island02919-
Research SitePawtucketRhode Island02860-
Research SiteAndersonSouth Carolina29621-
Research SiteCharlestonSouth Carolina29407-
Research SiteCharlestonSouth Carolina29425-
Research SiteColumbiaSouth Carolina29204-
Research SiteFountain InnSouth Carolina29644-
Research SiteMoncks CornerSouth Carolina29461-
Research SiteMt. PleasantSouth Carolina29464-
Research SiteNorth Myrtle BeachSouth Carolina29582-
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Research SiteRapid CitySouth Dakota57701-
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Research SiteMemphisTennessee38112-
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Research SiteTullahomaTennessee37388-
Research SiteArlingtonTexas76012-
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Research SiteKerrvilleTexas78028-
Research SiteLongviewTexas75605-
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Research SitePlanoTexas75023-
Research SitePlanoTexas75024-
Research SiteSan AntonioTexas78229-
Research SiteSugar LandTexas77478-
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Research SiteWichita FallsTexas76301-
Research SiteLaytonUtah84041-
Research SiteMurrayUtah84107-
Research SiteWest JordanUtah84088-
Research SiteWhite River JunctionVermont05009-
Research SiteBurkeVirginia22015-
Research SiteDanvilleVirginia24541-
Research SiteFalls ChurchVirginia22042-
Research SiteHopewellVirginia23860-
Research SiteRichmondVirginia23219-
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Research SiteVirginia BeachVirginia23455-
Research SiteFederal WayWashington98003-
Research SiteSeattleWashington98104-
Research SiteSeattleWashington98195-
Research SiteSelahWashington98942-
Research SiteGreen BayWisconsin54301-
Research SiteMadisonWisconsin53713-
Research SiteMarshfieldWisconsin54449-

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