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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)

RecruitingTaking participants now, according to the registry record.
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In brief

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 sought252 sites3 countries

Categories

Cardiovascular100%

Registered in 1 registry

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Trial information is shown as published by the registry, in its original language.

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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.

Summary

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\[a\]).

Conditions

  • Cardiovascular Disease

Eligibility

SexAll
Ages50 Years – 105 Years
Healthy volunteersNo

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 3
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingDOUBLE (2)
Enrolment11,000 participants sought

Sponsor and collaborators

  • Amgen Sponsor

Arms and interventions

  • OlpasiranEXPERIMENTAL

    Participants will receive subcutaneous (SC) olpasiran.

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive SC placebo.

Interventions

  • Drug Olpasiran

    Olpasiran will be administered via SC injection.

  • Drug Placebo

    Placebo will be administered via SC injection.

Outcome measures

  1. Primary outcome

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

    Time frame Up to approximately 6.2 years

  2. Secondary outcome

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

    Time frame Up to approximately 6.2 years

  3. Secondary outcome

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

    Time frame Up to approximately 6.2 years

  4. Secondary outcome

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

    Time frame Baseline and Week 48

  5. Secondary outcome

    Time to Myocardial Infarction

    Time frame Up to approximately 6.2 years

  6. Secondary outcome

    Time to CHD Death or Myocardial Infarction, Whichever Occurs First

    Time frame Up to approximately 6.2 years

  7. Secondary outcome

    Time to Urgent Coronary Revascularization

    Time frame Up to approximately 6.2 years

  8. Secondary outcome

    Time to Coronary Revascularization

    Time frame Up to approximately 6.2 years

  9. Secondary outcome

    Time to CHD Death

    Time frame Up to approximately 6.2 years

  10. Secondary outcome

    Time to Cardiovascular Death

    Time frame Up to approximately 6.2 years

  11. Secondary outcome

    Time to Death by any Cause

    Time frame Up to approximately 6.2 years

  12. Secondary outcome

    Time to Ischemic Stroke

    Time frame Up to approximately 6.2 years

  13. Secondary outcome

    Serum Concentration of Olpasiran

    Time frame Up to Week 48

  14. Secondary outcome

    Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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

    Time frame Up to approximately 6.2 years

Dates

Start dateAugust 22, 2025 (actual)
Primary completionOctober 20, 2031 (estimated)
CompletionOctober 20, 2031 (estimated)
First postedAugust 22, 2025 (actual)
Last updatedAugust 21, 2026
Results postedNot stated in the registry record
Status last verifiedAugust 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

240 sites are recruiting

Australia

FacilityCityState or regionStatus
Advara HeartCare WesleyAuchenflowerQueenslandRecruiting
Flinders Medical CentreBedford ParkSouth AustraliaRecruiting
Royal Prince Alfred HospitalCamperdownNew South WalesRecruiting
NovatrialsCharlestownNew South WalesRecruiting
Victorian Heart HospitalClaytonVictoriaRecruiting
Concord Repatriation General HospitalConcordNew South WalesRecruiting
Canberra HospitalGarranAustralian Capital TerritoryRecruiting
Clinitrials - MandurahGreenfieldsWestern AustraliaRecruiting
Advara HeartCare JoondalupJoondalupWestern AustraliaRecruiting
Advara HeartCare LeabrookLeabrookSouth AustraliaRecruiting
The Alfred HospitalMelbourneVictoriaRecruiting
Momentum Clinical Research - SunshineMelbourneVictoriaRecruiting
Aim ResearchMerewetherNew South WalesRecruiting
Core Research Group Pty LtdMiltonQueenslandRecruiting
Hollywood Private HospitalNedlandsWestern AustraliaRecruiting
Linear Clinical Research LimitedNedlandsWestern AustraliaRecruiting
Fusion Clinical ResearchNorwoodSouth AustraliaRecruiting
Orange Health ServiceOrangeNew South WalesRecruiting
Clinitrials - West PerthPerthWestern AustraliaRecruiting
University of The Sunshine Coast Clinical Trials, Sippy DownsSippy DownsQueenslandRecruiting
Wollongong HospitalWollongongNew South WalesRecruiting
Dr Heart Pty LtdWoolloongabbaQueenslandRecruiting

Canada

FacilityCityState or regionStatus
Centricity Research BramptonBramptonOntarioRecruiting
Circulate Cardiac & Vascular CentreBurlingtonOntarioRecruiting
Centricity Research CalgaryCalgaryAlbertaRecruiting
Cambridge Cardiac Care CentreCambridgeOntarioRecruiting
Ecogene-21ChicoutimiQuebecRecruiting
Edmonton Cardiology ConsultantsEdmontonAlbertaRecruiting
Premier Clinical Trial NetworkHamiltonOntarioCompleted
Hamilton Health Sciences Hamilton General HospitalHamiltonOntarioRecruiting
St Josephs HospitalLondonOntarioRecruiting
Elevate Clinical Research KMH MissisaugaMississaugaOntarioRecruiting
Centre de Recherche du Centre Hospitalier de l Universite de MontrealMontrealQuebecRecruiting
Research Institute of McGill University Health Center - Glen SiteMontrealQuebecRecruiting
Montreal Heart InstituteMontrealQuebecRecruiting
Institut de recherches cliniques de MontrealMontrealQuebecRecruiting
Fraser Clinical TrialsNew WestminsterBritish ColumbiaRecruiting
Partners in Advanced Cardiac EvaluationNewmarketOntarioRecruiting
North York Diagnostic and Cardiac CentreNorth YorkOntarioRecruiting
Oakville Cardiovascular ResearchOakvilleOntarioRecruiting
Heart Health Institute Research IncorporatedScarborough VillageOntarioRecruiting
CIUSSS de l Estrie CHUS Hopital FleurimontSherbrookeQuebecRecruiting
SMH Cardiology Clinical Trials IncorporatedSurreyBritish ColumbiaRecruiting
Womens College HospitalTorontoOntarioRecruiting
ARC Biosystems IncorporatedVancouverBritish ColumbiaRecruiting
Victoria Heart Institute FoundationVictoriaBritish ColumbiaRecruiting
Discovery Clinical Services LtdVictoriaBritish ColumbiaRecruiting

United States

FacilityCityState or regionStatus
Albany Medical CollegeAlbanyNew YorkRecruiting
Advanced Cardiovascular LLCAlexander CityAlabamaRecruiting
PharmaTex Research, LLCAmarilloTexasRecruiting

202 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. August 13, 2026

    Site added

    1 site added (252 total)

    251252

  2. August 7, 2026

    Site added

    2 sites added (251 total)

    249251

Registry: ClinicalTrials.gov · NCT########

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