OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

NCT07136012
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
11,000
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Lead sponsor
Amgen
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Start date
2025-08-22
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Number of sites
252
clinicaltrials.gov

Summary
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\[a\]).
clinicaltrials.gov
Short title
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
clinicaltrials.gov
Official title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With 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
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-10-20
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First posted
2025-08-22
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Registry last updated
2026-08-21
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Primary completion date
2031-10-20
clinicaltrials.gov
Start date
2025-08-22
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Participants
11,000
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Participant count basis
Estimated
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Planned participants
11,000
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Protocol amendments
0
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Number of sites
252
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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
NCT07136012
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ClinicalTrials.gov ID
NCT07136012
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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: Up to approximately 6.2 years

  1. Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First

    Timeframe: Up to approximately 6.2 years

  2. Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First

    Timeframe: Up to approximately 6.2 years

  3. Percent Change From Baseline to Week 48 Lp(a) Levels

    Timeframe: Baseline and Week 48

  4. Time to Myocardial Infarction

    Timeframe: Up to approximately 6.2 years

  5. Time to CHD Death or Myocardial Infarction, Whichever Occurs First

    Timeframe: Up to approximately 6.2 years

  6. Time to Urgent Coronary Revascularization

    Timeframe: Up to approximately 6.2 years

  7. Time to Coronary Revascularization

    Timeframe: Up to approximately 6.2 years

  8. Time to CHD Death

    Timeframe: Up to approximately 6.2 years

  9. Time to Cardiovascular Death

    Timeframe: Up to approximately 6.2 years

  10. Time to Death by any Cause

    Timeframe: Up to approximately 6.2 years

  11. Time to Ischemic Stroke

    Timeframe: Up to approximately 6.2 years

  12. Serum Concentration of Olpasiran

    Timeframe: Up to Week 48

  13. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to approximately 6.2 years

    Including serious adverse events and adverse events leading to discontinuation of investigational product.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Maximum age
105 Years
Healthy volunteers
No

  • Age ≥50 years
  • Lp(a)≥ 200 nmol/L during screening
  • Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

  • Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
  • Prior or planned arterial revascularization
  • History of major bleeding disorder
Sources for eligibility
clinicaltrials.gov

  • Advanced Cardiovascular LLCAlexander City, United StatesRecruiting
  • University of Alabama Birmingham Saint Vincents BirminghamBirmingham, United StatesRecruiting
  • Birmingham Clinical ResearchBirmingham, United StatesRecruiting
  • Alliance For Multispecialty Research - DaphneDaphne, United StatesRecruiting
  • Eastern Shore Research InstituteFairhope, United StatesRecruiting
  • Heart Center Research LLCHuntsville, United StatesRecruiting
  • CB Flock Research CorporationMobile, United StatesRecruiting
  • Phoenix ClinicalPhoenix, United StatesRecruiting
  • Elite Clinical Studies LLCPhoenix, United StatesRecruiting
  • Hero Clinical ResearchPhoenix, United StatesRecruiting
  • HonorHealth Research InstituteScottsdale, United StatesRecruiting
  • Eclipse Clinical ResearchTucson, United StatesRecruiting
  • Lynn Institute of the OzarksLittle Rock, United StatesRecruiting
  • National Heart InstituteBeverly Hills, United StatesRecruiting
  • 310 Clinical ResearchInglewood, United StatesRecruiting
  • University of California San DiegoLa Jolla, United StatesRecruiting
  • InvivoCureLos Angeles, United StatesRecruiting
  • Valley Clinical TrialsNorthridge, United StatesRecruiting
  • Clinical Trials Research - SacramentoRoseville, United StatesRecruiting
  • Alliance Clinical ResearchSan Diego, United StatesRecruiting
  • Encompass Clinical ResearchSpring Valley, United StatesRecruiting
  • Stanford Health CareStanford, United StatesRecruiting
  • Manshadi Heart InstituteStockton, United StatesRecruiting
  • Blue Coast CardiologyVista, United StatesRecruiting
  • Diablo Clinical ResearchWalnut Creek, United StatesRecruiting

And 227 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (1)