A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

Part of paid clinical trials in Athens, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07000357
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cardiovascular Disease

Eligibility Criteria

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

Interventions

  • AZD0780 — DRUG
    Participants will receive oral AZD0780 once daily
  • Placebo — DRUG
    Participants will receive oral placebo once daily

Study Details

The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.

Key Dates

Start date
Jun 4, 2025
Status verified
Jun 2026
Primary completion
Oct 26, 2029
Completion
Oct 26, 2029

Study Design

Enrollment
15,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD0780
    Participants will receive oral AZD0780 once daily
  • Placebo Comparator: Placebo
    Participants will receive oral placebo once daily

Primary Outcome Measure

Time to first event of any component of MACE-PLUS [ Time Frame: Up to approximately 54 months ]

Central Contacts

Locations (315)

FacilityCityStateZIPSite coordinators
Research SiteAthensAlabama35611-
Research SiteBirminghamAlabama35205-
Research SiteFairhopeAlabama36532-
Research SiteFoleyAlabama36535-
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteMobileAlabama36608-
Research SiteSaralandAlabama36571-
Research SiteVestavia HillsAlabama35216-
Research SiteGilbertArizona85296-
Research SiteGlendaleArizona85308-
Research SiteMesaArizona85206-
Research SitePeoriaArizona85382-
Research SitePhoenixArizona85014-
Research SitePhoenixArizona85051-
Research SitePhoenixArizona85053-
Research SiteScottsdaleArizona85260-
Research SiteTempeArizona85283-
Research SiteTucsonArizona85715-
Research SiteTucsonArizona85741-
Research SiteTucsonArizona85745-
Research SiteLittle RockArkansas72205-
Research SiteBeverly HillsCalifornia90211-
Research SiteCanoga ParkCalifornia91303-
Research SiteCastrovilleCalifornia95012-
Research SiteChula VistaCalifornia91911-
Research SiteFountain ValleyCalifornia92708-
Research SiteGarden GroveCalifornia92844-
Research SiteLa JollaCalifornia92037-
Research SiteLake ForestCalifornia92630-
Research SiteLancasterCalifornia93534-
Research SiteLoma LindaCalifornia92350-
Research SiteLoma LindaCalifornia92357-
Research SiteLos AngelesCalifornia90017-
Research SiteLos AngelesCalifornia90035-
Research SiteLynwoodCalifornia90262-
Research SiteMonterey ParkCalifornia91754-
Research SiteNewport BeachCalifornia92663-
Research SiteNorcoCalifornia92860-
Research SiteNorthridgeCalifornia91325-
Research SitePomonaCalifornia91768-
Research SitePowayCalifornia92064-
Research SiteRiversideCalifornia92503-
Research SiteSacramentoCalifornia95817-
Research SiteSan DiegoCalifornia92111-
Research SiteSan DimasCalifornia91773-
Research SiteSanta AnaCalifornia92705-
Research SiteStanfordCalifornia94305-
Research SiteTarzanaCalifornia91356-
Research SiteThousand OaksCalifornia91360-
Research SiteTorranceCalifornia90502-
Research SiteWest HillsCalifornia91307-
Research SiteStamfordConnecticut06905-
Research SiteWaterburyConnecticut06708-
Research SiteBoca RatonFlorida33486-
Research SiteClearwaterFlorida33756-
Research SiteCoral GablesFlorida33134-
Research SiteCrystal RiverFlorida34429-
Research SiteDeLandFlorida32720-
Research SiteFleming IslandFlorida32003-
Research SiteFort LauderdaleFlorida33308-
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Research SiteGainesvilleFlorida32608-
Research SiteGainesvilleFlorida32610-
Research SiteHallandaleFlorida33009-
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Research SiteOcalaFlorida34470-
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Research SiteBeltsvilleMaryland20705-
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Research SiteRockvilleMaryland20850-
Research SiteSalisburyMaryland21801-
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Research SiteDuluthMinnesota55805-
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Research SiteJefferson CityMissouri65109-
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Research SiteKansas CityMissouri64128-
Research SiteKansas CityMissouri64151-
Research SiteSpringfieldMissouri65807-
Research SiteSt LouisMissouri63110-
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Research SiteMissoulaMontana59808-
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Research SiteWilkes-BarrePennsylvania18711-
Research SiteYardleyPennsylvania19067-
Research SiteProvidenceRhode Island02908-
Research SiteCharlestonSouth Carolina29402-
Research SiteFort MillSouth Carolina29707-
Research SiteMauldinSouth Carolina29662-
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Research SiteNorth CharlestonSouth Carolina29405-
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Research SiteRapid CitySouth Dakota57701-
Research SiteChattanoogaTennessee37404-
Research SiteChattanoogaTennessee37421-
Research SiteElizabethtonTennessee37643-
Research SiteKnoxvilleTennessee37849-
Research SiteKnoxvilleTennessee37912-
Research SiteKnoxvilleTennessee37938-
Research SiteMemphisTennessee38119-
Research SiteMemphisTennessee38128-
Research SiteMorristownTennessee37813-
Research SiteNashvilleTennessee37232-
Research SiteTullahomaTennessee37388-
Research SiteAmarilloTexas79106-
Research SiteBeaumontTexas77706-
Research SiteBrownsvilleTexas78526-
Research SiteCorpus ChristiTexas78404-
Research SiteDallasTexas75216-
Research SiteDallasTexas75234-
Research SiteDallasTexas75246-
Research SiteDallasTexas75390-
Research SiteDeSotoTexas75115-
Research SiteEl PasoTexas79902-
Research SiteEl PasoTexas79905-
Research SiteEulessTexas76040-
Research SiteHoustonTexas77002-
Research SiteHoustonTexas77025-
Research SiteHoustonTexas77034-
Research SiteHoustonTexas77043-
Research SiteHoustonTexas77087-
Research SiteHumbleTexas77338-
Research SiteIrvingTexas75061-
Research SiteKatyTexas77450-
Research SiteKingwoodTexas77339-
Research SiteKingwoodTexas77345-
Research SiteMcAllenTexas78503-
Research SiteMcKinneyTexas75069-
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Research SiteOdessaTexas79761-
Research SiteParisTexas75462-
Research SitePearlandTexas77584-
Research SitePharrTexas78577-
Research SitePlanoTexas75093-
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Research SiteTempleTexas76508-
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Research SiteTylerTexas75701-
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Research SiteRoyUtah84067-
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Research SiteWhite River JunctionVermont05001-
Research SiteCharlottesvilleVirginia22911-
Research SiteFairfaxVirginia22031-
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Research SiteHenricoVirginia23229-
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Research SiteManassasVirginia20109-
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Research SiteRentonWashington98057-
Research SiteSeattleWashington98122-
Research SiteTacomaWashington98405-
Research SiteMorgantownWest Virginia26505-
Research SiteMadisonWisconsin53792-

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