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

NCT05581303
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
7,297
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Lead sponsor
Amgen
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Start date
2022-12-14
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Number of sites
737
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Summary
The primary objective of this trial 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).
clinicaltrials.gov
Short title
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
clinicaltrials.gov
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-03-31
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First posted
2022-10-14
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Registry last updated
2026-02-27
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Primary completion date
2028-03-31
clinicaltrials.gov
Start date
2022-12-14
clinicaltrials.gov

Actual participants
7,297
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Participants
7,297
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
737
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05581303
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ClinicalTrials.gov ID
NCT05581303
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first

    Timeframe: Approximately 5 years

  1. Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first

    Timeframe: Approximately 5 years

  2. Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first

    Timeframe: Approximately 5 years

  3. Percent change from baseline to Week 48 in Lipoprotein(a)

    Timeframe: Baseline and Week 48

  4. Time to myocardial infarction

    Timeframe: Approximately 5 years

  5. Time to CHD death or myocardial infarction, whichever occurs first

    Timeframe: Approximately 5 years

  6. Time to urgent coronary revascularization

    Timeframe: Approximately 5 years

  7. Time to coronary revascularization

    Timeframe: Approximately 5 years

  8. Time to CHD death

    Timeframe: Approximately 5 years

  9. Time to cardiovascular death

    Timeframe: Approximately 5 years

  10. Time to death by any cause

    Timeframe: Approximately 5 years

  11. Time to ischemic stroke

    Timeframe: Approximately 5 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No

  • 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.

  • 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)
Sources for eligibility
clinicaltrials.gov

  • Ascension Saint Vincents BirminghamBirmingham, United States
  • Grandview Medical Center Affinity Cardiovascular Specialists, LLCBirmingham, United States
  • Heart Center Research LLCHuntsville, United States
  • Mobile Heart Specialists PCMobile, United States
  • Alaska Cardiovascular Research FoundationAnchorage, United States
  • Elite Clinical Studies LLCPhoenix, United States
  • HonorHealth Research and Innovation InstituteScottsdale, United States
  • National Heart InstituteBeverly Hills, United States
  • Vitality Clinical ResearchBeverly Hills, United States
  • University of California San DiegoLa Jolla, United States
  • VA Greater Los Angeles Healthcare SystemLos Angeles, United States
  • University of California IrvineOrange, United States
  • University of California Los AngelesSanta Monica, United States
  • Manshadi Heart InstituteStockton, United States
  • Med Partners, Inc dba Premiere Medical Center, IncToluca Lake, United States
  • UCHealth Memorial CentralColorado Springs, United States
  • Cardiology Associates of Fairfield County PCStamford, United States
  • MedStar Clinical ResearchWashington D.C., United States
  • Excel Medical Clinical TrialsBoca Raton, United States
  • Bay Area CardiologyBrandon, United States
  • Clearwater Cardiovascular ConsultantsClearwater, United States
  • Cardiology Associates Research LLCDaytona Beach, United States
  • Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine CareFort Lauderdale, United States
  • Elite Cardiac Research Center LLCHialeah, United States
  • East Coast Institute for Research, LLCJacksonville, United States

And 712 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-501608-85
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)