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NCT07136012ClinicalTrials.gov

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)

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En resumen

The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with…

Fase 311.000 participantes buscados252 centros3 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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 2025-08-22; recorded start 2025-08-22
  • 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 303 other studies in this databaseCounted from the lead sponsor named in the record (Amgen)
  • 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

  • Blinding13/20

    Double-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: 249 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: 11,000 participants (target), run at 252 sites, across 3 countries.

How this score is built
  • Enrolment38/40

    11,000 participants (target)

  • Site count25/25

    249 sites

  • Country count7/15

    3 countries

  • Planned duration10/10

    Planned over about 75 months

  • Sponsor scale9/10

    Amgen has led 300 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 primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).

Afecciones

  • Cardiovascular Disease

Elegibilidad

SexoTodos
Edades50 Years – 105 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Age ≥50 years * Lp(a)≥ 200 nmol/L during screening * Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis Exclusion Criteria: * Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia) * Prior or planned arterial revascularization * History of major bleeding disorder

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
EnmascaramientoDOUBLE (2)
Inscripción11.000 participantes buscados

Patrocinador y colaboradores

  • Amgen Patrocinador

Grupos e intervenciones

  • OlpasiranEXPERIMENTAL

    Participants will receive subcutaneous (SC) olpasiran.

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive SC placebo.

Intervenciones

  • Fármaco Olpasiran

    Olpasiran will be administered via SC injection.

  • Fármaco Placebo

    Placebo will be administered via SC injection.

Variables de resultado

  1. Variable de resultado principal

    Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First

    Plazo Up to approximately 6.2 years

  2. Variable de resultado secundaria

    Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First

    Plazo Up to approximately 6.2 years

  3. Variable de resultado secundaria

    Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First

    Plazo Up to approximately 6.2 years

  4. Variable de resultado secundaria

    Percent Change From Baseline to Week 48 Lp(a) Levels

    Plazo Baseline and Week 48

  5. Variable de resultado secundaria

    Time to Myocardial Infarction

    Plazo Up to approximately 6.2 years

  6. Variable de resultado secundaria

    Time to CHD Death or Myocardial Infarction, Whichever Occurs First

    Plazo Up to approximately 6.2 years

  7. Variable de resultado secundaria

    Time to Urgent Coronary Revascularization

    Plazo Up to approximately 6.2 years

  8. Variable de resultado secundaria

    Time to Coronary Revascularization

    Plazo Up to approximately 6.2 years

  9. Variable de resultado secundaria

    Time to CHD Death

    Plazo Up to approximately 6.2 years

  10. Variable de resultado secundaria

    Time to Cardiovascular Death

    Plazo Up to approximately 6.2 years

  11. Variable de resultado secundaria

    Time to Death by any Cause

    Plazo Up to approximately 6.2 years

  12. Variable de resultado secundaria

    Time to Ischemic Stroke

    Plazo Up to approximately 6.2 years

  13. Variable de resultado secundaria

    Serum Concentration of Olpasiran

    Plazo Up to Week 48

  14. Variable de resultado secundaria

    Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Including serious adverse events and adverse events leading to discontinuation of investigational product.

    Plazo Up to approximately 6.2 years

Fechas

Fecha de inicio22 de agosto de 2025 (real)
Finalización principal20 de octubre de 2031 (estimada)
Finalización20 de octubre de 2031 (estimada)
Primera publicación22 de agosto de 2025 (real)
Última actualización21 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

240 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Advara HeartCare WesleyAuchenflowerQueenslandEn reclutamiento
Flinders Medical CentreBedford ParkSouth AustraliaEn reclutamiento
Royal Prince Alfred HospitalCamperdownNew South WalesEn reclutamiento
NovatrialsCharlestownNew South WalesEn reclutamiento
Victorian Heart HospitalClaytonVictoriaEn reclutamiento
Concord Repatriation General HospitalConcordNew South WalesEn reclutamiento
Canberra HospitalGarranAustralian Capital TerritoryEn reclutamiento
Clinitrials - MandurahGreenfieldsWestern AustraliaEn reclutamiento
Advara HeartCare JoondalupJoondalupWestern AustraliaEn reclutamiento
Advara HeartCare LeabrookLeabrookSouth AustraliaEn reclutamiento
The Alfred HospitalMelbourneVictoriaEn reclutamiento
Momentum Clinical Research - SunshineMelbourneVictoriaEn reclutamiento
Aim ResearchMerewetherNew South WalesEn reclutamiento
Core Research Group Pty LtdMiltonQueenslandEn reclutamiento
Hollywood Private HospitalNedlandsWestern AustraliaEn reclutamiento
Linear Clinical Research LimitedNedlandsWestern AustraliaEn reclutamiento
Fusion Clinical ResearchNorwoodSouth AustraliaEn reclutamiento
Orange Health ServiceOrangeNew South WalesEn reclutamiento
Clinitrials - West PerthPerthWestern AustraliaEn reclutamiento
University of The Sunshine Coast Clinical Trials, Sippy DownsSippy DownsQueenslandEn reclutamiento
Wollongong HospitalWollongongNew South WalesEn reclutamiento
Dr Heart Pty LtdWoolloongabbaQueenslandEn reclutamiento

Canada

CentroCiudadEstado o regiónEstado
Centricity Research BramptonBramptonOntarioEn reclutamiento
Circulate Cardiac & Vascular CentreBurlingtonOntarioEn reclutamiento
Centricity Research CalgaryCalgaryAlbertaEn reclutamiento
Cambridge Cardiac Care CentreCambridgeOntarioEn reclutamiento
Ecogene-21ChicoutimiQuebecEn reclutamiento
Edmonton Cardiology ConsultantsEdmontonAlbertaEn reclutamiento
Premier Clinical Trial NetworkHamiltonOntarioCompletado
Hamilton Health Sciences Hamilton General HospitalHamiltonOntarioEn reclutamiento
St Josephs HospitalLondonOntarioEn reclutamiento
Elevate Clinical Research KMH MissisaugaMississaugaOntarioEn reclutamiento
Centre de Recherche du Centre Hospitalier de l Universite de MontrealMontrealQuebecEn reclutamiento
Research Institute of McGill University Health Center - Glen SiteMontrealQuebecEn reclutamiento
Montreal Heart InstituteMontrealQuebecEn reclutamiento
Institut de recherches cliniques de MontrealMontrealQuebecEn reclutamiento
Fraser Clinical TrialsNew WestminsterBritish ColumbiaEn reclutamiento
Partners in Advanced Cardiac EvaluationNewmarketOntarioEn reclutamiento
North York Diagnostic and Cardiac CentreNorth YorkOntarioEn reclutamiento
Oakville Cardiovascular ResearchOakvilleOntarioEn reclutamiento
Heart Health Institute Research IncorporatedScarborough VillageOntarioEn reclutamiento
CIUSSS de l Estrie CHUS Hopital FleurimontSherbrookeQuebecEn reclutamiento
SMH Cardiology Clinical Trials IncorporatedSurreyBritish ColumbiaEn reclutamiento
Womens College HospitalTorontoOntarioEn reclutamiento
ARC Biosystems IncorporatedVancouverBritish ColumbiaEn reclutamiento
Victoria Heart Institute FoundationVictoriaBritish ColumbiaEn reclutamiento
Discovery Clinical Services LtdVictoriaBritish ColumbiaEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
Albany Medical CollegeAlbanyNew YorkEn reclutamiento
Advanced Cardiovascular LLCAlexander CityAlabamaEn reclutamiento
PharmaTex Research, LLCAmarilloTexasEn reclutamiento

En el registro figuran 202 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 13 de agosto de 2026

    Centro añadido

    1 site added (252 total)

    251252

  2. 7 de agosto de 2026

    Centro añadido

    2 sites added (251 total)

    249251

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

https://xmedica.io/trials/ctgov/NCT07136012