Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial (OCEAN(a)-CCTA)

April 15, 2026 updated by: Amgen

A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
406

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Advara HeartCare Wesley
      • Sippy Downs, Queensland, Australia, 4556
        • Recruiting
        • University of the Sunshine Coast Clinical Trials, Sippy Downs
    • South Australia
      • Leabrook, South Australia, Australia, 5068
        • Recruiting
        • Advara HeartCare Leabrook
  • Canada
    • Ontario
      • Vaughan, Ontario, Canada, L6A 4N9
        • Recruiting
        • North York Diagnostic and Cardiac Centre
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third XIANGYA Hospital of Central South University
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial Peoples Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
  • Denmark
      • Herning, Denmark, 7400
        • Recruiting
        • Regionshospitalet Gødstrup
      • Viborg, Denmark, 8800
        • Recruiting
        • Regionshospitalet Viborg
  • France
      • Nice, France, 06000
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur
      • Pessac, France, 33604
        • Recruiting
        • Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque
      • Toulouse, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
      • Tours, France, 37044
        • Recruiting
        • Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen
      • Frankfurt am Main, Germany, 60590
        • Recruiting
        • Universitaetsklinikum Frankfurt
      • München, Germany, 80636
        • Recruiting
        • Klinikum rechts der Isar der TUM
  • Italy
      • Ferrara, Italy, 44124
        • Recruiting
        • Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna
      • Milan, Italy, 20138
        • Recruiting
        • IRCCS Centro Cardiologico Monzino
      • San Donato Milanese, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
      • Torino, Italy, 10128
        • Recruiting
        • Azienda Ospedaliera Ordine Mauriziano Di Torino
  • Japan
    • Hokkaido
      • Tomakomai-shi, Hokkaido, Japan, 053-8567
        • Recruiting
        • Tomakomai City Hospital
    • Osaka
      • Osaka, Osaka, Japan, 543-0042
        • Recruiting
        • Osaka Keisatsu Hospital
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • Recruiting
        • University of Yamanashi Hospital
  • Netherlands
      • Hilversum, Netherlands, 1201 DA
        • Recruiting
        • Tergooiziekenhuizen, locatie Hilversum
  • Spain
      • Madrid, Spain, 28023
        • Recruiting
        • Hospital Universitario Ramon y Cajal
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
    • Galicia
      • Vigo, Galicia, Spain, 36312
        • Recruiting
        • Hospital Alvaro Cunqueiro
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Recruiting
        • Bridgeport Hospital
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Midwest Heart and Vascular Specialists
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish Bowie
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Montefiore Medical Center - Bronx
    • Texas
      • Humble, Texas, United States, 77338
        • Recruiting
        • Vital Heart and Vein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 35 to ≤ 80 years.
  • Lp(a) ≥ 200 nmol/L during screening.
  • Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.
  • History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.

Exclusion Criteria:

  • History of coronary artery bypass graft (CABG).
  • Moderate to severe renal dysfunction.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening.
  • History of hemorrhagic stroke.
  • History of major bleeding disorder.
  • Planned cardiac surgery or arterial revascularization.
  • Severe heart failure.
  • Current, recent, or planned lipoprotein apheresis.
  • Previously received ribonucleic acid therapy specifically targeting Lp(a).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Olpasiran
Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).
Drug: Olpasiran
Olpasiran will be administered SC.
Other Names:
  • AMG 890
Placebo Comparator: Placebo
Participants will receive placebo SC Q12W.
Drug: Placebo
Placebo will be administered SC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in NCP Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Low Attenuation Plaque Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in Total Plaque Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72
Change in Calcified Plaque Volume from Baseline to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 74
Up to Week 74

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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