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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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati252 centri3 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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\[a\]).

Patologie

  • Cardiovascular Disease

Idoneità

SessoTutti
Età50 Years – 105 Years
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoDOUBLE (2)
Arruolamento11.000 partecipanti ricercati

Sponsor e collaboratori

  • Amgen Sponsor

Bracci e interventi

  • OlpasiranEXPERIMENTAL

    Participants will receive subcutaneous (SC) olpasiran.

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive SC placebo.

Interventi

  • Farmaco Olpasiran

    Olpasiran will be administered via SC injection.

  • Farmaco Placebo

    Placebo will be administered via SC injection.

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale Up to approximately 6.2 years

  2. Esito secondario

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

    Orizzonte temporale Up to approximately 6.2 years

  3. Esito secondario

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

    Orizzonte temporale Up to approximately 6.2 years

  4. Esito secondario

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

    Orizzonte temporale Baseline and Week 48

  5. Esito secondario

    Time to Myocardial Infarction

    Orizzonte temporale Up to approximately 6.2 years

  6. Esito secondario

    Time to CHD Death or Myocardial Infarction, Whichever Occurs First

    Orizzonte temporale Up to approximately 6.2 years

  7. Esito secondario

    Time to Urgent Coronary Revascularization

    Orizzonte temporale Up to approximately 6.2 years

  8. Esito secondario

    Time to Coronary Revascularization

    Orizzonte temporale Up to approximately 6.2 years

  9. Esito secondario

    Time to CHD Death

    Orizzonte temporale Up to approximately 6.2 years

  10. Esito secondario

    Time to Cardiovascular Death

    Orizzonte temporale Up to approximately 6.2 years

  11. Esito secondario

    Time to Death by any Cause

    Orizzonte temporale Up to approximately 6.2 years

  12. Esito secondario

    Time to Ischemic Stroke

    Orizzonte temporale Up to approximately 6.2 years

  13. Esito secondario

    Serum Concentration of Olpasiran

    Orizzonte temporale Up to Week 48

  14. Esito secondario

    Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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

    Orizzonte temporale Up to approximately 6.2 years

Date

Data di inizio22 agosto 2025 (effettiva)
Conclusione primaria20 ottobre 2031 (stimata)
Conclusione20 ottobre 2031 (stimata)
Prima pubblicazione22 agosto 2025 (effettiva)
Ultimo aggiornamento21 agosto 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaagosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

240 centri stanno reclutando

Australia

StrutturaCittàStato o regioneStato
Advara HeartCare WesleyAuchenflowerQueenslandIn reclutamento
Flinders Medical CentreBedford ParkSouth AustraliaIn reclutamento
Royal Prince Alfred HospitalCamperdownNew South WalesIn reclutamento
NovatrialsCharlestownNew South WalesIn reclutamento
Victorian Heart HospitalClaytonVictoriaIn reclutamento
Concord Repatriation General HospitalConcordNew South WalesIn reclutamento
Canberra HospitalGarranAustralian Capital TerritoryIn reclutamento
Clinitrials - MandurahGreenfieldsWestern AustraliaIn reclutamento
Advara HeartCare JoondalupJoondalupWestern AustraliaIn reclutamento
Advara HeartCare LeabrookLeabrookSouth AustraliaIn reclutamento
The Alfred HospitalMelbourneVictoriaIn reclutamento
Momentum Clinical Research - SunshineMelbourneVictoriaIn reclutamento
Aim ResearchMerewetherNew South WalesIn reclutamento
Core Research Group Pty LtdMiltonQueenslandIn reclutamento
Hollywood Private HospitalNedlandsWestern AustraliaIn reclutamento
Linear Clinical Research LimitedNedlandsWestern AustraliaIn reclutamento
Fusion Clinical ResearchNorwoodSouth AustraliaIn reclutamento
Orange Health ServiceOrangeNew South WalesIn reclutamento
Clinitrials - West PerthPerthWestern AustraliaIn reclutamento
University of The Sunshine Coast Clinical Trials, Sippy DownsSippy DownsQueenslandIn reclutamento
Wollongong HospitalWollongongNew South WalesIn reclutamento
Dr Heart Pty LtdWoolloongabbaQueenslandIn reclutamento

Canada

StrutturaCittàStato o regioneStato
Centricity Research BramptonBramptonOntarioIn reclutamento
Circulate Cardiac & Vascular CentreBurlingtonOntarioIn reclutamento
Centricity Research CalgaryCalgaryAlbertaIn reclutamento
Cambridge Cardiac Care CentreCambridgeOntarioIn reclutamento
Ecogene-21ChicoutimiQuebecIn reclutamento
Edmonton Cardiology ConsultantsEdmontonAlbertaIn reclutamento
Premier Clinical Trial NetworkHamiltonOntarioCompletato
Hamilton Health Sciences Hamilton General HospitalHamiltonOntarioIn reclutamento
St Josephs HospitalLondonOntarioIn reclutamento
Elevate Clinical Research KMH MissisaugaMississaugaOntarioIn reclutamento
Centre de Recherche du Centre Hospitalier de l Universite de MontrealMontrealQuebecIn reclutamento
Research Institute of McGill University Health Center - Glen SiteMontrealQuebecIn reclutamento
Montreal Heart InstituteMontrealQuebecIn reclutamento
Institut de recherches cliniques de MontrealMontrealQuebecIn reclutamento
Fraser Clinical TrialsNew WestminsterBritish ColumbiaIn reclutamento
Partners in Advanced Cardiac EvaluationNewmarketOntarioIn reclutamento
North York Diagnostic and Cardiac CentreNorth YorkOntarioIn reclutamento
Oakville Cardiovascular ResearchOakvilleOntarioIn reclutamento
Heart Health Institute Research IncorporatedScarborough VillageOntarioIn reclutamento
CIUSSS de l Estrie CHUS Hopital FleurimontSherbrookeQuebecIn reclutamento
SMH Cardiology Clinical Trials IncorporatedSurreyBritish ColumbiaIn reclutamento
Womens College HospitalTorontoOntarioIn reclutamento
ARC Biosystems IncorporatedVancouverBritish ColumbiaIn reclutamento
Victoria Heart Institute FoundationVictoriaBritish ColumbiaIn reclutamento
Discovery Clinical Services LtdVictoriaBritish ColumbiaIn reclutamento

United States

StrutturaCittàStato o regioneStato
Albany Medical CollegeAlbanyNew YorkIn reclutamento
Advanced Cardiovascular LLCAlexander CityAlabamaIn reclutamento
PharmaTex Research, LLCAmarilloTexasIn reclutamento

Nella scheda del registro sono indicati altri 202 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 13 agosto 2026

    Centro aggiunto

    1 site added (252 total)

    251252

  2. 7 agosto 2026

    Centro aggiunto

    2 sites added (251 total)

    249251

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

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