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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)

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 311 000 participants recherchés252 sites3 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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\[a\]).

Affections

  • Cardiovascular Disease

Éligibilité

SexeTous
Âges50 Years – 105 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuDOUBLE (2)
Recrutement11 000 participants recherchés

Promoteur et collaborateurs

  • Amgen Promoteur

Groupes et interventions

  • OlpasiranEXPERIMENTAL

    Participants will receive subcutaneous (SC) olpasiran.

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive SC placebo.

Interventions

  • Médicament Olpasiran

    Olpasiran will be administered via SC injection.

  • Médicament Placebo

    Placebo will be administered via SC injection.

Critères de jugement

  1. Critère de jugement principal

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

    Délai Up to approximately 6.2 years

  2. Critère de jugement secondaire

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

    Délai Up to approximately 6.2 years

  3. Critère de jugement secondaire

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

    Délai Up to approximately 6.2 years

  4. Critère de jugement secondaire

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

    Délai Baseline and Week 48

  5. Critère de jugement secondaire

    Time to Myocardial Infarction

    Délai Up to approximately 6.2 years

  6. Critère de jugement secondaire

    Time to CHD Death or Myocardial Infarction, Whichever Occurs First

    Délai Up to approximately 6.2 years

  7. Critère de jugement secondaire

    Time to Urgent Coronary Revascularization

    Délai Up to approximately 6.2 years

  8. Critère de jugement secondaire

    Time to Coronary Revascularization

    Délai Up to approximately 6.2 years

  9. Critère de jugement secondaire

    Time to CHD Death

    Délai Up to approximately 6.2 years

  10. Critère de jugement secondaire

    Time to Cardiovascular Death

    Délai Up to approximately 6.2 years

  11. Critère de jugement secondaire

    Time to Death by any Cause

    Délai Up to approximately 6.2 years

  12. Critère de jugement secondaire

    Time to Ischemic Stroke

    Délai Up to approximately 6.2 years

  13. Critère de jugement secondaire

    Serum Concentration of Olpasiran

    Délai Up to Week 48

  14. Critère de jugement secondaire

    Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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

    Délai Up to approximately 6.2 years

Dates

Date de début22 août 2025 (réelle)
Achèvement principal20 octobre 2031 (estimée)
Achèvement20 octobre 2031 (estimée)
Première publication22 août 2025 (réelle)
Dernière mise à jour21 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

240 sites sont en recrutement

Australia

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

Canada

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

United States

ÉtablissementVilleÉtat ou régionStatut
Albany Medical CollegeAlbanyNew YorkEn recrutement
Advanced Cardiovascular LLCAlexander CityAlabamaEn recrutement
PharmaTex Research, LLCAmarilloTexasEn recrutement

202 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 13 août 2026

    Site ajouté

    1 site added (252 total)

    251252

  2. 7 août 2026

    Site ajouté

    2 sites added (251 total)

    249251

Registre: ClinicalTrials.gov · NCT########

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