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NCT07000357ClinicalTrials.gov

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

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

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En resumen

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…

Fase 315.100 participantes buscados1452 centros36 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-06-02; recorded start 2025-06-04
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 1365 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 15,100 participants (target), run at 1,452 sites, across 36 countries.

How this score is built
  • Enrolment39/40

    15,100 participants (target)

  • Site count25/25

    1,365 sites

  • Country count15/15

    36 countries

  • Planned duration9/10

    Planned over about 54 months

  • Sponsor scale10/10

    AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

  • Cardiovascular Disease

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Meets one of the following: 1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening Additional risk factors based on the level of the LDL-C and timing of MI or stroke: o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors (i to viii) below. ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD 2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii): (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases: 1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin/creatinine ratio ≥ 30 mg/g) and/or persistent eGFR \< 60 mL/min/1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening 2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist 3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist 4. ABI \< 0.9 or \> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance For (ii) and (iii), participants need to have at least one of the additional risk factors below: <!-- --> 1. CKD with eGFR x mL/min/1.73 m2 2. Current tobacco use 3. Age ≥ 65 4. T2DM (if included on the less significant atherosclerosis criterion iii) * Participants should receive a background lipid lowering regimen anticipated to achieve at least a \~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid). Participants must achieve a stable background lipid lowering therapy \> 28 days before screening. Exclusion criteria: * Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results. * Any revascularisation procedure planned within the next 3 months. * Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis. * Calculated eGFR \< 15 mL /min/1.73 m2 at screening. * Any laboratory values with the following deviations at screening: * AST or ALT \> 3 × ULN * TBL \> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN) * Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L). * Creatine kinase \> 5 × ULN * Urine albumin/creatinine ratio ≥ 500 mg/g * Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening. * Inadequately treated hypothyroidism defined as TSH \> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening. * Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study. * Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study. * Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción15.100 participantes buscados

Patrocinador y colaboradores

  • AstraZeneca Patrocinador

Grupos e intervenciones

  • AZD0780EXPERIMENTAL

    Participants will receive oral AZD0780 once daily

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive oral placebo once daily

Intervenciones

  • Fármaco AZD0780

    Participants will receive oral AZD0780 once daily

  • Fármaco Placebo

    Participants will receive oral placebo once daily

Variables de resultado

  1. Variable de resultado principal

    Time to first event of any component of MACE-PLUS

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS (the composite of CV death, myocardial infarction \[MI\], ischaemic stroke, acute lower limb ischaemia, major amputation of a vascular aetiology, and urgent arterial revascularisation)

    Plazo Up to approximately 54 months

  2. Variable de resultado secundaria

    Time to first event of any component of 3P MACE

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of 3-point (3P)-MACE (the composite of CV death, MI, and ischaemic stroke)

    Plazo Up to approximately 54 months

  3. Variable de resultado secundaria

    Time to first event of any component of MACE PLUS

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS in patients with a history of ASCVD

    Plazo Up to approximately 54 months

  4. Variable de resultado secundaria

    Time to first event of MI

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MI

    Plazo Up to approximately 54 months

  5. Variable de resultado secundaria

    Time to first event of urgent coronary revascularisation

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of urgent coronary revascularisation

    Plazo Up to approximately 54 months

  6. Variable de resultado secundaria

    Time to CV death

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of CV death

    Plazo Up to approximately 54 months

  7. Variable de resultado secundaria

    Time to first event of MALE

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of major adverse limb event (MALE) (the composite of acute lower limb ischaemia, major amputation of vascular aetiology, and urgent lower extremity revascularisation)

    Plazo Up to approximately 54 months

  8. Variable de resultado secundaria

    Time to all-cause mortality

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of all-cause mortality

    Plazo Up to approximately 54 months

Fechas

Fecha de inicio4 de junio de 2025 (real)
Finalización principal26 de octubre de 2029 (estimada)
Finalización26 de octubre de 2029 (estimada)
Primera publicación2 de junio de 2025 (real)
Última actualización24 de agosto de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

1106 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Research SiteCABAEn reclutamiento
Research SiteCABAEn reclutamiento
Research SiteCapital FederalEn reclutamiento
Research SiteCiudad Autonoma de Bs AsEn reclutamiento
Research SiteCiudad de Buenos AiresEn reclutamiento
Research SiteCiudad de Buenos AiresEn reclutamiento
Research SiteCiudad de Buenos AiresEn reclutamiento
Research SiteCiudad de Buenos AiresEn reclutamiento
Research SiteCiudad de Buenos AiresEn reclutamiento
Research SiteCiudad de RosarioEn reclutamiento
Research SiteCórdobaEn reclutamiento
Research SiteCórdobaEn reclutamiento
Research SiteCórdobaEn reclutamiento
Research SiteGodoy CruzEn reclutamiento
Research SiteLanús EsteEn reclutamiento
Research SiteMar del PlataEn reclutamiento
Research SiteNueva CórdobaEn reclutamiento
Research SiteRosarioEn reclutamiento
Research SiteRosarioEn reclutamiento
Research SiteRosarioEn reclutamiento
Research SiteRosarioEn reclutamiento
Research SiteSan JuanEn reclutamiento
Research SiteSan Miguel de TucumánEn reclutamiento
Research SiteSan NicolásEn reclutamiento
Research SiteSanta RosaEn reclutamiento
Research SiteZárateEn reclutamiento

Brazil

CentroCiudadEstado o regiónEstado
Research SiteAracajuEn reclutamiento
Research SiteBarretosEn reclutamiento
Research SiteBelo HorizonteEn reclutamiento
Research SiteBelo HorizonteEn reclutamiento
Research SiteBelo HorizonteEn reclutamiento
Research SiteBelémEn reclutamiento
Research SiteBlumenauEn reclutamiento
Research SiteBrasíliaEn reclutamiento
Research SiteBrasíliaEn reclutamiento
Research SiteBrasíliaEn reclutamiento
Research SiteCampina Grande do SulEn reclutamiento
Research SiteCampinasEn reclutamiento
Research SiteCampinasEn reclutamiento
Research SiteCampinasEn reclutamiento
Research SiteCampinasEn reclutamiento
Research SiteCriciúmaEn reclutamiento
Research SiteCuritibaRetirado
Research SiteCuritibaEn reclutamiento
Research SiteCuritibaEn reclutamiento
Research SiteGoiâniaEn reclutamiento
Research SiteJuiz de ForaEn reclutamiento
Research SiteMaríliaEn reclutamiento
Research SiteNatalEn reclutamiento
Research SitePonta GrossaEn reclutamiento

En el registro figuran 1402 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 24 de agosto de 2026

    Centro añadido

    87 sites added (1452 total)

    13651452

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07000357