Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
DalCor Pharmaceuticals
Study ID
NCT05918861
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Acute Coronary Syndrome

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dalcetrapib — DRUG
    Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
  • Placebo — DRUG
    matching placebo tablets

Study Details

This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Key Dates

Start date
Oct 3, 2023
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dalcetrapib
    Dalcetrapib 600 mg (two 300 mg tablets) orally once daily
  • Placebo Comparator: Placebo
    Matching dalcetrapib placebo tablets (2 tablets) orally once per day

Primary Outcome Measure

Time to first occurrence of any fatal or non-fatal myocardial infarction (MI) [ Time Frame: Average of 30 months from randomization ]

Central Contacts

Locations (178)

FacilityCityStateZIPSite coordinators
Research SiteAlexander CityAlabama35010-
Research SiteBirminghamAlabama35211-
Research SiteFairhopeAlabama36532-
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteScottsdaleArizona85258-
Research SiteTucsonArizona85724-
Research SiteJonesboroArkansas72405-
Research SiteNorth Little RockArkansas72117-
Research SiteGarden GroveCalifornia92844-
Research SiteHuntington BeachCalifornia92648-
Research SiteLa JollaCalifornia92037-
Research SiteLong BeachCalifornia90813-
Research SiteLos AngelesCalifornia90025-
Research SiteNewport BeachCalifornia92648-
Research SiteNewport BeachCalifornia92658-
Research SiteSan FranciscoCalifornia94143-
Research SiteSanta BarbaraCalifornia93105-
Research SiteStanfordCalifornia94305-
Research SiteTorranceCalifornia90502-
Research SiteWest HillsCalifornia91307-
Research SiteAuroraColorado80011-
Research SiteGoldenColorado80401-
Research SiteHartfordConnecticut06102-
Research SiteNew HavenConnecticut06519-
Research SiteNewarkDelaware19718-
Research SiteWashington D.C.District of Columbia20010-
Research SiteWashington D.C.District of Columbia20060-
Research SiteBoca RatonFlorida33434-
Research SiteBoca RatonFlorida33486-
Research SiteClearwaterFlorida33756-
Research SiteDoralFlorida33166-
Research SiteFort LauderdaleFlorida33316-
Research SiteFort MyersFlorida33908-
Research SiteGainesvilleFlorida32608-
Research SiteHialeahFlorida33013-
Research SiteHomesteadFlorida33030-
Research SiteJacksonvilleFlorida32209-
Research SiteKissimmeeFlorida34741-
Research SiteLargoFlorida33777-
Research SiteMiamiFlorida33032-
Research SiteMiamiFlorida33033-
Research SiteMiamiFlorida33136-
Research SiteMiamiFlorida33145-
Research SiteMiamiFlorida33175-
Research SiteMiami LakesFlorida33014-
Research SiteMiami LakesFlorida33016-
Research SiteOcalaFlorida34471-
Research SitePembroke PinesFlorida33024-
Research SitePensacolaFlorida32502-
Research SitePort CharlotteFlorida33952-
Research SiteSafety HarborFlorida34695-
Research SiteSarasotaFlorida34239-
Research SiteTallahasseeFlorida32308-
Research SiteTampaFlorida33606-
Research SiteTampaFlorida33607-
Research SiteWinter HavenFlorida33881-
Research SiteAcworthGeorgia30101-
Research SiteAtlantaGeorgia30310-
Research SiteAtlantaGeorgia30322-
Research SiteAugustaGeorgia30912-
Research SiteGainesvilleGeorgia30501-
Research SiteMcDonoughGeorgia30253-
Research SiteArlington HeightsIllinois60005-
Research SiteBloomingdaleIllinois60108-
Research SiteChicagoIllinois60612-
Research SiteChicagoIllinois60616-
Research SiteGlenviewIllinois60026-
Research SiteHazel CrestIllinois60429-
Research SitePark RidgeIllinois60068-
Research SiteSpringfieldIllinois62702-
Research SiteFort WayneIndiana46845-
Research SiteIndianapolisIndiana46202-
Research SiteMerrillvilleIndiana46410-
Research SiteMunsterIndiana46321-
Research SiteNewburghIndiana47630-
Research SiteRichmondIndiana47374-
Research SiteDavenportIowa52801-
Research SiteIowa CityIowa52242-
Research SiteWest Des MoinesIowa50266-
Research SiteKansas CityKansas66160-
Research SiteEdgewoodKentucky41017-
Research SiteLexingtonKentucky40536-
Research SiteLouisvilleKentucky40202-
Research SiteHammondLouisiana70403-
Research SiteLafayetteLouisiana70503-
Research SiteMandevilleLouisiana70448-
Research SiteNew OrleansLouisiana70121-
Research SiteBangorMaine04401-
Research SiteBaltimoreMaryland21215-
Research SiteBethesdaMaryland20814-
Research SiteBowieMaryland20715-
Research SiteColumbiaMaryland21044-
Research SiteNottinghamMaryland21236-
Research SiteBay CityMichigan48708-
Research SiteDearbornMichigan48126-
Research SiteDetroitMichigan48202-
Research SiteKalamazooMichigan49048-
Research SiteMidlandMichigan48670-
Research SiteMount ClemensMichigan48043-
Research SitePetoskeyMichigan49770-
Research SiteTraverse CityMichigan49684-
Research SiteYpsilantiMichigan48197-
Research SiteCoon RapidsMinnesota55433-
Research SiteDuluthMinnesota55805-
Research SiteMinneapolisMinnesota55407-
Research SiteMinneapolisMinnesota55417-
Research SiteSaint CloudMinnesota56303-
Research SiteTupeloMississippi38801-
Research SiteSpringfieldMissouri65804-
Research SiteSt LouisMissouri63103-
Research SiteSt LouisMissouri63110-
Research SiteSt LouisMissouri63136-
Research SiteLincolnNebraska68506-
Research SiteOmahaNebraska68124-
Research SiteLas VegasNevada89102-
Research SiteBridgewaterNew Jersey08807-
Research SiteHackensackNew Jersey07601-
Research SitePomonaNew Jersey08240-
Research SiteAlbuquerqueNew Mexico87102-
Research SiteAlbanyNew York12211-
Research SiteBuffaloNew York14203-
Research SiteJohnson CityNew York13790-
Research SiteNew YorkNew York10028-
Research SitePoughkeepsieNew York12601-
Research SiteStaten IslandNew York10310-
Research SiteStony BrookNew York11794-
Research SiteThe BronxNew York10467-
Research SitePinehurstNorth Carolina28374-
Research SiteRocky MountNorth Carolina27804-
Research SiteSanfordNorth Carolina27330-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteCantonOhio44710-
Research SiteCincinnatiOhio45219-
Research SiteClevelandOhio44106-
Research SiteSpringfieldOhio45504-
Research SiteToledoOhio43608-
Research SiteAllentownPennsylvania18013-
Research SiteAllentownPennsylvania18103-
Research SiteChambersburgPennsylvania17201-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19107-
Research SiteWest ReadingPennsylvania19611-
Research SiteWyomissingPennsylvania19610-
Research SiteProvidenceRhode Island02906-
Research SiteRock HillSouth Carolina29732-
Research SiteSpartanburgSouth Carolina29303-
Research SiteRapid CitySouth Dakota57701-
Research SiteChattanoogaTennessee37403-
Research SiteGreenevilleTennessee37745-
Research SiteJefferson CityTennessee37760-
Research SiteMemphisTennessee38120-
Research SiteOak RidgeTennessee37830-
Research SitePowellTennessee37849-
Research SiteAmarilloTexas79106-
Research SiteBeaumontTexas77702-
Research SiteCorpus ChristiTexas78404-
Research SiteCypressTexas77429-
Research SiteDallasTexas75216-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-1503-
Research SiteHoustonTexas77070-
Research SiteHoustonTexas77089-
Research SiteHoustonTexas77090-
Research SiteKingwoodTexas77339-
Research SiteMcKinneyTexas75071-
Research SiteMesquiteTexas75149-
Research SitePort ArthurTexas77642-
Research SiteSan AntonioTexas78207-
Research SiteVictoriaTexas77901-
Research SiteWacoTexas76712-
Research SiteNewport NewsVirginia23606-
Research SiteNorfolkVirginia23504-
Research SiteRichmondVirginia23219-
Research SiteWinchesterVirginia22601-
Research SiteSeattleWashington98122-

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