Home/Get Matched/NCT07136012
Phase 3Recruiting
View on ClinicalTrials.gov

Testing Olpasiran against a placebo for cardiovascular disease

Official title: 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)

Condition: Cardiovascular DiseaseSponsor: AmgenTarget enrollment: 11000
  • Phase 3
  • 2 groups
  • Sites in Calgary, Edmonton and 17 more cities
  • Recruiting
Premier Clinical Trial Network, Hamilton, OntarioCentricity Research Calgary, Calgary, AlbertaEdmonton Cardiology Consultants, Edmonton, AlbertaFraser Clinical Trials, New Westminster, British ColumbiaSMH Cardiology Clinical Trials Incorporated, Surrey, British ColumbiaARC Biosystems Incorporated, Vancouver, British ColumbiaVictoria Heart Institute Foundation, Victoria, British ColumbiaDiscovery Clinical Services Ltd, Victoria, British ColumbiaCentricity Research Brampton, Brampton, OntarioCirculate Cardiac & Vascular Centre, Burlington, OntarioCambridge Cardiac Care Centre, Cambridge, OntarioHamilton Health Sciences Hamilton General Hospital, Hamilton, OntarioSt Josephs Hospital, London, OntarioElevate Clinical Research KMH Missisauga, Mississauga, OntarioPartners in Advanced Cardiac Evaluation, Newmarket, OntarioOakville Cardiovascular Research, Oakville, OntarioHeart Health Institute Research Incorporated, Scarborough Village, OntarioWomens College Hospital, Toronto, OntarioEcogene-21, Chicoutimi, QuebecMontreal Heart Institute, Montreal, QuebecInstitut de recherches cliniques de Montreal, Montreal, QuebecCentre de Recherche du Centre Hospitalier de l Universite de Montreal, Montreal, QuebecResearch Institute of McGill University Health Center - Glen Site, Montreal, QuebecCIUSSS de l Estrie CHUS Hopital Fleurimont, Sherbrooke, Quebec

Interventions

  • Medication

    Olpasiran

    Olpasiran will be administered via SC injection.

  • Medication

    Placebo

    Placebo will be administered via SC injection.

Canadian Sites (25)

24 of 25 recruiting

  • Centricity Research Calgary

    Calgary, Alberta

    Recruiting
  • Edmonton Cardiology Consultants

    Edmonton, Alberta

    Recruiting
  • Fraser Clinical Trials

    New Westminster, British Columbia

    Recruiting

Eligibility Criteria

See who this study is looking for6 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Age ≥50 years
  • +Lp(a)≥ 200 nmol/L during screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
  • +Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

Exclusion

  • Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
  • Prior or planned arterial revascularization
  • History of major bleeding disorder
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Olpasiran.

Registry label: A: Olpasiran

Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.

Registry label: B: Placebo

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

Neither you nor the study team would know which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 50 years to 105 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 11,000 people.

The study is currently expected to finish around October 2031.

The main measurement is taken over: Up to approximately 6.2 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First — measured over Up to approximately 6.2 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07136012 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About OlpasiranDrug

Olpasiran will be administered via SC injection.

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PlaceboDrug

Placebo will be administered via SC injection.

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 50 years to 105 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

Neither you nor the study team would know which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 50 years to 105 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Up to approximately 6.2 years.

The study as a whole is currently expected to finish around 2031-10-20.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 11,000 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 41 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; New Westminster, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada, and 35 more.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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\[a\]).

Other Sites (23)

Henry Ford Health System

Detroit, Michigan, United States

Healthy Heart Cardiology

Grand Rapids, Michigan, United States

MyMichigan Medical Center Midland - Clinical Research Department

Midland, Michigan, United States

Advanced Cardiology Associates

Rochester Hills, Michigan, United States

Revival Research Institute

Southfield, Michigan, United States

Saint Marys Medical Center

Duluth, Minnesota, United States

Health East Cancer Care

Maplewood, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Methodist Hospital

Saint Louis Park, Minnesota, United States

Albany Medical College

Albany, New York, United States

Basil Clinical

Inwood, New York, United States

Rasai Research

Jackson Heights, New York, United States

Crystal Run Healthcare

Monroe, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Mount Sinai Queens

New York, New York, United States

Ima Clinical Research Manhattan

New York, New York, United States

Niagara Falls Memorial Medical Center

Niagara Falls, New York, United States

Circuit Clinical Orchard Park Family Practice

Orchard Park, New York, United States

Hudson Valley Cardiovascular Physicians PC

Poughkeepsie, New York, United States

And 3 more sites worldwide.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.