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Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05581303
Recruitment Status : Recruiting
First Posted : October 14, 2022
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Drug: Placebo Drug: Olpasiran Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
Actual Study Start Date : December 14, 2022
Estimated Primary Completion Date : December 16, 2026
Estimated Study Completion Date : December 16, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo will be administered by subcutaneous injection, plus standard of care.
 Drug: Placebo
Placebo given by subcutaneous injection once every 12 weeks (Q12W).
Experimental: Olpasiran
Olpasiran will be administered by subcutaneous injection, plus standard of care.
 Drug: Olpasiran
Olpasiran given by subcutaneous injection once every 12 weeks (Q12W).


Outcome Measures
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Primary Outcome Measures :
  1. Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first [ Time Frame: Approximately 4 years ]

Secondary Outcome Measures :
  1. Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first [ Time Frame: Approximately 4 years ]
  2. Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first [ Time Frame: Approximately 4 years ]
  3. Percent change from baseline to Week 48 in Lipoprotein(a) [ Time Frame: Baseline and Week 48 ]
  4. Time to myocardial infarction [ Time Frame: Approximately 4 years ]
  5. Time to CHD death or myocardial infarction, whichever occurs first [ Time Frame: Approximately 4 years ]
  6. Time to urgent coronary revascularization [ Time Frame: Approximately 4 years ]
  7. Time to coronary revascularization [ Time Frame: Approximately 4 years ]
  8. Time to CHD death [ Time Frame: Approximately 4 years ]
  9. Time to cardiovascular death [ Time Frame: Approximately 4 years ]
  10. Time to death by any cause [ Time Frame: Approximately 4 years ]
  11. Time to ischemic stroke [ Time Frame: Approximately 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to ≤ 85 years
  • Lp(a) ≥ 200 nmol/L during screening

  • History of ASCVD as evidenced by history of either:

    • Myocardial infarction and/or
    • Coronary revascularization with percutaneous coronary intervention with stenting AND at least 1 additional risk factor

Exclusion Criteria:

  • Severe renal dysfunction
  • Active liver disease, known hepatitis, or hepatic dysfunction
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05581303


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05581303    
Other Study ID Numbers: 20180244
First Posted: October 14, 2022    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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 link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Atherosclerotic Cardiovascular Disease
ASCVD
AMG 890
Olpasiran
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases