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

• ClinicalTrials.gov Identifier: NCT05581303
• Recruitment Status: Active, not recruiting
• First Posted: October 14, 2022
• Last Update Posted: April 4, 2024
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: October 12, 2022
• First Posted Date: October 14, 2022
• Last Update Posted Date: April 4, 2024
• Actual Study Start Date: December 14, 2022
• Estimated Primary Completion Date: December 29, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 9, 2022): Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first [ Time Frame: Approximately 4 years ]
• Original Primary Outcome Measures (submitted: October 12, 2022): Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first [ Time Frame: Anticipated median around 4 years ]

Current Secondary Outcome Measures (submitted: December 9, 2022)

• Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first [ Time Frame: Approximately 4 years ]
• Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first [ Time Frame: Approximately 4 years ]
• Percent change from baseline to Week 48 in Lipoprotein(a) [ Time Frame: Baseline and Week 48 ]
• Time to myocardial infarction [ Time Frame: Approximately 4 years ]
• Time to CHD death or myocardial infarction, whichever occurs first [ Time Frame: Approximately 4 years ]
• Time to urgent coronary revascularization [ Time Frame: Approximately 4 years ]
• Time to coronary revascularization [ Time Frame: Approximately 4 years ]
• Time to CHD death [ Time Frame: Approximately 4 years ]
• Time to cardiovascular death [ Time Frame: Approximately 4 years ]
• Time to death by any cause [ Time Frame: Approximately 4 years ]
• Time to ischemic stroke [ Time Frame: Approximately 4 years ]

Original Secondary Outcome Measures (submitted: October 12, 2022)

• Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first [ Time Frame: Anticipated median around 4 years ]
• Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first [ Time Frame: Anticipated median around 4 years ]
• Percent change from baseline to Week 48 in Lipoprotein(a) [ Time Frame: Baseline and Week 48 ]
• Time to myocardial infarction [ Time Frame: Anticipated median around 4 years ]
• Time to CHD death or myocardial infarction, whichever occurs first [ Time Frame: Anticipated median around 4 years ]
• Time to urgent coronary revascularization [ Time Frame: Anticipated median around 4 years ]
• Time to coronary revascularization [ Time Frame: Anticipated median around 4 years ]
• Time to CHD death [ Time Frame: Anticipated median around 4 years ]
• Time to cardiovascular death [ Time Frame: Anticipated median around 4 years ]
• Time to death by any cause [ Time Frame: Anticipated median around 4 years ]
• Time to ischemic stroke [ Time Frame: Anticipated median around 4 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
• 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)
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Atherosclerotic Cardiovascular Disease

Intervention

• Drug: Placebo
  Placebo given by subcutaneous injection once every 12 weeks (Q12W).
• Drug: Olpasiran
  Olpasiran given by subcutaneous injection Q12W.

Study Arms

• Placebo Comparator: Placebo
  Placebo will be administered by subcutaneous injection
  Intervention: Drug: Placebo
• Experimental: Olpasiran
  Olpasiran will be administered by subcutaneous injection
  Intervention: Drug: Olpasiran

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 3, 2024): 7297
• Original Estimated Enrollment (submitted: October 12, 2022): 6000
• Estimated Study Completion Date: December 29, 2026
• Estimated Primary Completion Date: December 29, 2026 (Final data collection date for primary outcome measure)

Eligibility 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 (presumed type 1 event due to plaque rupture/erosion) and/or
  • Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.

Exclusion Criteria:

• 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05581303
• Other Study ID Numbers: 20180244
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: 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

• Current Responsible Party: Amgen
• Original Responsible Party: Same as current
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: April 2024