OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)
1 other identifier
interventional
11,000
3 countries
243
Brief 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\[a\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2025
Longer than P75 for phase_3
243 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedStudy Start
First participant enrolled
August 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 20, 2031
May 1, 2026
April 1, 2026
6.2 years
August 18, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
Up to approximately 6.2 years
Secondary Outcomes (13)
Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First
Up to approximately 6.2 years
Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First
Up to approximately 6.2 years
Percent Change From Baseline to Week 48 Lp(a) Levels
Baseline and Week 48
Time to Myocardial Infarction
Up to approximately 6.2 years
Time to CHD Death or Myocardial Infarction, Whichever Occurs First
Up to approximately 6.2 years
- +8 more secondary outcomes
Study Arms (2)
Olpasiran
EXPERIMENTALParticipants will receive subcutaneous (SC) olpasiran.
Placebo
PLACEBO COMPARATORParticipants will receive SC placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥50 years
- Lp(a)≥ 200 nmol/L during screening
- Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
You may not qualify if:
- Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
- Prior or planned arterial revascularization
- History of major bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (243)
Advanced Cardiovascular LLC
Alexander City, Alabama, 35010, United States
University of Alabama Birmingham Saint Vincents Birmingham
Birmingham, Alabama, 35205, United States
Birmingham Clinical Research
Birmingham, Alabama, 35209, United States
Alliance For Multispecialty Research - Daphne
Daphne, Alabama, 36526, United States
Eastern Shore Research Institute
Fairhope, Alabama, 36532, United States
Heart Center Research LLC
Huntsville, Alabama, 35801, United States
CB Flock Research Corporation
Mobile, Alabama, 36608, United States
Phoenix Clinical
Phoenix, Arizona, 85014, United States
Elite Clinical Studies LLC
Phoenix, Arizona, 85018, United States
Hero Clinical Research
Phoenix, Arizona, 85021, United States
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Eclipse Clinical Research
Tucson, Arizona, 85745, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
National Heart Institute
Beverly Hills, California, 90211, United States
310 Clinical Research
Inglewood, California, 90301, United States
University of California San Diego
La Jolla, California, 92037, United States
InvivoCure
Los Angeles, California, 91405, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Clinical Trials Research - Sacramento
Roseville, California, 95661, United States
Alliance Clinical Research
San Diego, California, 92120, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Stanford Health Care
Stanford, California, 94305, United States
Manshadi Heart Institute
Stockton, California, 95204, United States
Blue Coast Cardiology
Vista, California, 92083, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Focus Clinical Research
West Hills, California, 91307, United States
Interventional Cardiology Medical Group
West Hills, California, 91307, United States
UCHealth Memorial Central
Colorado Springs, Colorado, 80909, United States
South Denver Cardiology Associates
Littleton, Colorado, 80120, United States
Gandelman Cardiology, PC
Greenwich, Connecticut, 06830, United States
ClinTrial Hamden
Hamden, Connecticut, 06518, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756, United States
Proactive Clinical Research
Fort Lauderdale, Florida, 33308, United States
Indago Research and Health Center
Hialeah, Florida, 33012, United States
Elite Cardiac Research Center LLC
Hialeah, Florida, 33013, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
East Coast Institute for Research, LLC
Lake City, Florida, 32055, United States
Columbus Clinical Services LLC
Miami, Florida, 33125, United States
Kendall South Medical Center
Miami, Florida, 33175, United States
Inpatient Research Clinic, LLC
Miami Lakes, Florida, 33014, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Eminat, LLC
Miramar, Florida, 33027, United States
Suncoast Clinical Research Inc
New Port Richey, Florida, 34652, United States
Ocala Cardiovascular Research
Ocala, Florida, 34471, United States
Ocala Research Institute, Inc
Ocala, Florida, 34474, United States
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174, United States
Baptist Health Care
Pensacola, Florida, 32514, United States
Denali Health Plant City
Plant City, Florida, 33563, United States
FWD Clinical Research
Tamarac, Florida, 33321, United States
Guardian Research Organization LLC
Winter Park, Florida, 32792, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
East Coast Institute for Research
Canton, Georgia, 30114, United States
Northeast Georgia Medical Center Wisteria Building
Cumming, Georgia, 30041, United States
Nsc Research
Johns Creek, Georgia, 30024, United States
Georgia Clinical Research
Lawrenceville, Georgia, 30044, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
St Lukes Idaho Cardiology Associates
Meridian, Idaho, 83642, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Endeavor Health-Northwest Community Healthcare
Arlington Heights, Illinois, 60005, United States
Christie Clinic
Champaign, Illinois, 61822, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Alliance for Multispecialty Research LLC - Park Ridge
Park Ridge, Illinois, 66068, United States
MediSphere Medical Research Center LLC
Evansville, Indiana, 47714, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Ascension Saint Vincent Heart Center
Indianapolis, Indiana, 46290, United States
Cardiovascular Research of Northwest Indiana LLC
Munster, Indiana, 46321, United States
Reid Physician Associates
Richmond, Indiana, 47374, United States
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Hutchinson Clinic PA
Hutchinson, Kansas, 67502, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
The Research Group of Lexington LLC
Lexington, Kentucky, 40503, United States
Heart Clinic of Hammond
Covington, Louisiana, 70433, United States
Ima Clinical Research
Monroe, Louisiana, 71201, United States
Louisiana Heart Center
Slidell, Louisiana, 70458, United States
Monroe Research LLC
West Monroe, Louisiana, 71291, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Metropolitan Cardiovascular Consultants LLC
Beltsville, Maryland, 20705, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Flourish Research
Bowie, Maryland, 20715, United States
Johns Hopkins University
Columbia, Maryland, 21044, United States
Centennial Medical Group
Columbia, Maryland, 21045, United States
Medstar Franklin Square Medical Center
Hyattsville, Maryland, 20782, United States
Capitol Cardiology Associates
Lanham, Maryland, 20706, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Healthy Heart Cardiology
Grand Rapids, Michigan, 49546, United States
MyMichigan Medical Center Midland - Clinical Research Department
Midland, Michigan, 48670, United States
Advanced Cardiology Associates
Rochester Hills, Michigan, 48307, United States
Revival Research Institute
Southfield, Michigan, 48034, United States
Saint Marys Medical Center
Duluth, Minnesota, 55805, United States
Health East Cancer Care
Maplewood, Minnesota, 55109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Methodist Hospital
Saint Louis Park, Minnesota, 55426, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
Cardiology Associates Research LLC
Tupelo, Mississippi, 38801, United States
Sisters of Saint Mary Health Heart and Vascular Care
Bridgeton, Missouri, 63044, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Washington University
St Louis, Missouri, 63110, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
American Institute of Medical Research
Las Vegas, Nevada, 89123, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Renown Institute for Heart and Vascular Health
Reno, Nevada, 89502, United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822, United States
Clinical Reseach Philadelphia Pennington
Hamilton, New Jersey, 08690, United States
Med Clinical Research Partners - Irvington
Irvington, New Jersey, 07111, United States
New Jersey Medcare / New Jersey Heart
Linden, New Jersey, 07036, United States
Saint Michaels Medical Center
Newark, New Jersey, 07102, United States
Circuit Clinical / Optum Medical Care of New Jersey
Secaucus, New Jersey, 07094, United States
The Heart House - Washington Township
Sewell, New Jersey, 08080, United States
CardioMetabolic Collaborative Clinic
Somerset, New Jersey, 08873, United States
Ima Clinical Research - Warren
Warren Township, New Jersey, 07059, United States
Albany Medical College
Albany, New York, 12203, United States
Basil Clinical
Inwood, New York, 11096, United States
Rasai Research
Jackson Heights, New York, 11372, United States
Crystal Run Healthcare
Monroe, New York, 10950, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Mount Sinai Queens
New York, New York, 10029, United States
Ima Clinical Research Manhattan
New York, New York, 10036, United States
Niagara Falls Memorial Medical Center
Niagara Falls, New York, 14304, United States
Circuit Clinical Orchard Park Family Practice
Orchard Park, New York, 14127, United States
Hudson Valley Cardiovascular Physicians PC
Poughkeepsie, New York, 12601, United States
Saratoga Clinical Research, LLC
Saratoga Springs, New York, 12866, United States
Duke University Health System
Durham, North Carolina, 27710, United States
Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Medication Management LLC
Greensboro, North Carolina, 27405, United States
Triad Clinical Trials, LLC
Greensboro, North Carolina, 27410, United States
ClinCept, LLC
Kinston, North Carolina, 28501, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Piedmont Healthcare
Statesville, North Carolina, 28625, United States
Accellacare Research of Wilmington
Wilmington, North Carolina, 28401, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Aultman Cardiology Clinical Trials
Canton, Ohio, 44710, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45219, United States
Nexgen Research
Lima, Ohio, 45801, United States
K and R Research
Marion, Ohio, 43302, United States
Alliance for Multispecialty Research
Norman, Oklahoma, 73069, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15236, United States
Pottstown Medical Specialists Inc
Pottstown, Pennsylvania, 19464, United States
Miriam Hospital
East Greenwich, Rhode Island, 02818, United States
Pharmacorp Clinical Trials Inc
Charleston, South Carolina, 29412, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Carolina Cardiology - Greenville
Gantt, South Carolina, 29605, United States
Walker Family Care
Little River, South Carolina, 29566, United States
Accellacare Charleston
Mt. Pleasant, South Carolina, 29464, United States
Tribe Clinical Research - Spartanburg
Spartanburg, South Carolina, 29301, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
Erlanger Health, Inc.
Chattanooga, Tennessee, 37403, United States
Apex Research Foundation, LLC
Jackson, Tennessee, 38301, United States
Alliance for Multispecialty Research Knoxville
Knoxville, Tennessee, 37909, United States
Ascension Saint Thomas
Nashville, Tennessee, 37205, United States
Parkway Cardiology Associates
Oak Ridge, Tennessee, 37830, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388, United States
PharmaTex Research, LLC
Amarillo, Texas, 79106, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731, United States
Ima Clinical Research
Austin, Texas, 78745, United States
Pioneer Medical Associates
Carrollton, Texas, 75007, United States
Baylor Scott and White Heart and Vascular Hospital-Dallas
Dallas, Texas, 75226, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
The Heartbeat Clinic
Dallas, Texas, 75243, United States
Cedar Health Research, LLC
Dallas, Texas, 75251, United States
Cedar Health Research, LLC
Euless, Texas, 76040, United States
East Texas Cardiology PA
Houston, Texas, 77002, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Cardiovascular Specialists of Willowbrook
Houston, Texas, 77070, United States
Vital Heart and Vein
Humble, Texas, 77338, United States
Tcr Institute Llc
Kingwood, Texas, 77339, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
Revival Research Institute
McKinney, Texas, 75071, United States
Texas Institute of Cardiology
McKinney, Texas, 75071, United States
Southern Endocrinology Associates PA
Mesquite, Texas, 75149, United States
Orion Medical
Pasadena, Texas, 77505, United States
Valley Institute of Research Plano
Plano, Texas, 75024, United States
Ima Clinical Research San Antonio
San Antonio, Texas, 78229, United States
St Davids Heart & Vascular PLLC dba Austin Heart
San Marcos, Texas, 78666, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Alpine Research Organization
Layton, Utah, 84041, United States
Inova Cardiology - Fairfax
Fairfax, Virginia, 22031, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Virginia Heart - Loudoun
Leesburg, Virginia, 20176, United States
Carient Heart and Vascular
Manassas, Virginia, 20109, United States
Bon Secours Cardiology
Midlothian, Virginia, 23114, United States
Tidewater Physicians Multispecialty Group Clinical Research
Newport News, Virginia, 23606, United States
Alliance for Multispecialty Research Norfolk
Norfolk, Virginia, 23502, United States
Centricity Research
Suffolk, Virginia, 23435, United States
Selma Medical Associates
Winchester, Virginia, 22601, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
Western Washington Medical Group
Everett, Washington, 98208, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Novatrials
Charlestown, New South Wales, 2290, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Aim Research
Merewether, New South Wales, 2291, Australia
Orange Health Service
Orange, New South Wales, 2800, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
Advara HeartCare Wesley
Auchenflower, Queensland, 4066, Australia
Core Research Group Pty Ltd
Milton, Queensland, 4064, Australia
University of The Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, 4556, Australia
Dr Heart Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Advara HeartCare Leabrook
Leabrook, South Australia, 5068, Australia
Fusion Clinical Research
Norwood, South Australia, 5067, Australia
Victorian Heart Hospital
Clayton, Victoria, 3168, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Momentum Clinical Research - Sunshine
Melbourne, Victoria, 3021, Australia
Clinitrials - Mandurah
Greenfields, Western Australia, 6210, Australia
Advara HeartCare Joondalup
Joondalup, Western Australia, 6027, Australia
Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, 6009, Australia
Clinitrials - West Perth
Perth, Western Australia, 6000, Australia
Centricity Research Calgary
Calgary, Alberta, T2H 2G4, Canada
Edmonton Cardiology Consultants
Edmonton, Alberta, T5H 4B9, Canada
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4, Canada
SMH Cardiology Clinical Trials Incorporated
Surrey, British Columbia, V3V 0C6, Canada
ARC Biosystems Incorporated
Vancouver, British Columbia, V6Z 1Y6, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 1B2, Canada
Discovery Clinical Services Ltd
Victoria, British Columbia, V8T 5G4, Canada
Centricity Research Brampton
Brampton, Ontario, L6S 0C6, Canada
Premier Clinical Trial Network
Hamilton, Ontario, L8L 5G4, Canada
Elevate Clinical Research KMH Missisauga
Mississauga, Ontario, L5K 2L3, Canada
Partners in Advanced Cardiac Evaluation
Newmarket, Ontario, L3Y 8C3, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7, Canada
Oakville Cardiovascular Research
Oakville, Ontario, L6K 3W7, Canada
Heart Health Institute Research Incorporated
Scarborough Village, Ontario, M1B 4Z8, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Institut de recherches cliniques de Montreal
Montreal, Quebec, H2W 1R7, Canada
Centre de Recherche du Centre Hospitalier de l Universite de Montreal
Montreal, Quebec, H2W 1T8, Canada
Research Institute of McGill University Health Center - Glen Site
Montreal, Quebec, H4A 3J1, Canada
CIUSSS de l Estrie CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 18, 2025
First Posted
August 22, 2025
Study Start
August 22, 2025
Primary Completion (Estimated)
October 20, 2031
Study Completion (Estimated)
October 20, 2031
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.