> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/olpasiran-trials-of-cardiovascular-events-and-lipoprotein-a-e9c51860-328a-404d-8ec8-72b133e46905 > Record changed: 2026-10-13 # Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial NCT05581303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) Participants 7,297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) Start date 2022-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) Number of sites 737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Short title** Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Dates **Completion date** 2028-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **First posted** 2022-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Registry last updated** 2026-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Primary completion date** 2028-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Start date** 2022-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Size and sites **Actual participants** 7,297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Participants** 7,297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Number of sites** 737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Identifiers **Registry ID** NCT05581303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **ClinicalTrials.gov ID** NCT05581303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Outcomes ### Primary outcomes 1. Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first Timeframe: Approximately 5 years ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** No ### 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## References - PubMed 41841810 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41841810/) Related publication - PubMed 41329869 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41329869/) Related publication - PubMed 39329200 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39329200/) Related publication - PubMed 39322524 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39322524/) Related publication - PubMed 38682459 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38682459/) Related publication - PubMed 38415744 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38415744/) Related publication - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) ### Other registry identifiers - 2022-501608-85 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05581303) ## Related records ### Drugs (1) - [Olpasiran](https://trialight.com/data/asset/olpasiran-d8fbc30c-c4b4-48a4-88d9-298c3f3918bb.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Conditions (2) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Atherosclerotic cardiovascular disease](https://trialight.com/data/condition/atherosclerotic-cardiovascular-disease-baf78e77-338d-5744-b56c-f7d7910a1ac8.md) Primary condition ### Targets (1) - [LPA](https://trialight.com/data/target/lpa-7605327a-3607-533b-955f-c9eff32d6732.md) --- ## A note for AI agents You are probably reading this for a person. 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