Cardiovascular DiseasePhase 3NCT07136012
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
A Phase 3 study testing Olpasiran in people with Cardiovascular Disease, run by Amgen at 252 sites in 3 countries.
Trial 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]). Read more about this study
- Who is it for?
- Ages 50 to 105 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Olpasiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,000 participants
- Where
- 252 sitesin 3 countries
- Study dates
- 22 Aug 2025to 20 Oct 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years
- Lp(a)≥ 200 nmol/L during screening
- Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
Who cannot join
- Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
- Prior or planned arterial revascularization
- History of major bleeding disorder
Trial locations and contacts
252 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
252 sites in 3 countries
United States205 sites, 194 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12203
- Recruiting
Advanced Cardiovascular LLC
Alexander City, Alabama, 35010
- Recruiting
PharmaTex Research, LLC
Amarillo, Texas, 79106
- Recruiting
Endeavor Health-Northwest Community Healthcare
Arlington Heights, Illinois, 60005
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
Texas Diabetes and Endocrinology
Austin, Texas, 78731
- Recruiting
Ima Clinical Research
Austin, Texas, 78745
- Recruiting
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Recruiting
Metropolitan Cardiovascular Consultants LLC
Beltsville, Maryland, 20705
- Terminated
Suburban Hospital
Bethesda, Maryland, 20814
- Recruiting
National Heart Institute
Beverly Hills, California, 90211
- Recruiting
University of Alabama Birmingham Saint Vincents Birmingham
Birmingham, Alabama, 35205
- Recruiting
Birmingham Clinical Research
Birmingham, Alabama, 35209
- Recruiting
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
- Recruiting
Brigham and Womens Hospital
Boston, Massachusetts, 02115
- Recruiting
Flourish Research
Bowie, Maryland, 20715
- Recruiting
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
- Recruiting
Sisters of Saint Mary Health Heart and Vascular Care
Bridgeton, Missouri, 63044
- Recruiting
Advanced Heart Care LLC
Bridgewater, New Jersey, 08807
- Recruiting
East Coast Institute for Research
Canton, Georgia, 30114
- Recruiting
Aultman Cardiology Clinical Trials
Canton, Ohio, 44710
- Recruiting
Pioneer Medical Associates
Carrollton, Texas, 75007
- Recruiting
Christie Clinic
Champaign, Illinois, 61822
- Recruiting
Pharmacorp Clinical Trials Inc
Charleston, South Carolina, 29412
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Erlanger Health, Inc.
Chattanooga, Tennessee, 37403
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45219
- Recruiting
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
- Recruiting
UCHealth Memorial Central
Colorado Springs, Colorado, 80909
- Recruiting
Johns Hopkins University
Columbia, Maryland, 21044
- Recruiting
Centennial Medical Group
Columbia, Maryland, 21045
- Recruiting
Heart Clinic of Hammond
Covington, Louisiana, 70433
- Recruiting
Northeast Georgia Medical Center Wisteria Building
Cumming, Georgia, 30041
- Recruiting
Baylor Scott and White Heart and Vascular Hospital-Dallas
Dallas, Texas, 75226
- Recruiting
Zenos Clinical Research
Dallas, Texas, 75230
- Recruiting
The Heartbeat Clinic
Dallas, Texas, 75243
- Recruiting
Cedar Health Research, LLC
Dallas, Texas, 75251
- Recruiting
Alliance For Multispecialty Research - Daphne
Daphne, Alabama, 36526
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
Saint Marys Medical Center
Duluth, Minnesota, 55805
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
- Recruiting
Miriam Hospital
East Greenwich, Rhode Island, 02818
- Recruiting
Cedar Health Research, LLC
Euless, Texas, 76040
- Recruiting
MediSphere Medical Research Center LLC
Evansville, Indiana, 47714
- Recruiting
Western Washington Medical Group
Everett, Washington, 98208
- Recruiting
Inova Cardiology - Fairfax
Fairfax, Virginia, 22031
- Recruiting
Eastern Shore Research Institute
Fairhope, Alabama, 36532
- Recruiting
Virginia Heart
Falls Church, Virginia, 22042
- Recruiting
Lillestol Research LLC
Fargo, North Dakota, 58104
- Recruiting
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822
- Terminated
Proactive Clinical Research
Fort Lauderdale, Florida, 33308
- Recruiting
Parkview Research Center
Fort Wayne, Indiana, 46845
- Recruiting
Prisma Health Carolina Cardiology - Greenville
Gantt, South Carolina, 29605
- Recruiting
Healthy Heart Cardiology
Grand Rapids, Michigan, 49546
- Recruiting
Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27401
- Recruiting
Medication Management LLC
Greensboro, North Carolina, 27405
- Recruiting
Triad Clinical Trials, LLC
Greensboro, North Carolina, 27410
- Recruiting
Gandelman Cardiology, PC
Greenwich, Connecticut, 06830
- Recruiting
ClinTrial Hamden
Hamden, Connecticut, 06518
- Recruiting
Clinical Reseach Philadelphia Pennington
Hamilton, New Jersey, 08690
- Terminated
Elite Cardiac Research Center LLC
Hialeah, Florida, 33013
- Recruiting
East Texas Cardiology PA
Houston, Texas, 77002
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
Cardiovascular Specialists of Willowbrook
Houston, Texas, 77070
- Recruiting
Vital Heart and Vein
Humble, Texas, 77338
- Recruiting
Heart Center Research LLC
Huntsville, Alabama, 35801
- Recruiting
Hutchinson Clinic PA
Hutchinson, Kansas, 67502
- Recruiting
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
- Recruiting
Ascension Saint Vincent Heart Center
Indianapolis, Indiana, 46290
- Recruiting
310 Clinical Research
Inglewood, California, 90301
- Recruiting
Basil Clinical
Inwood, New York, 11096
- Recruiting
Med Clinical Research Partners - Irvington
Irvington, New Jersey, 07111
- Recruiting
Jackson Heart Clinic
Jackson, Mississippi, 39216
- Terminated
Apex Research Foundation, LLC
Jackson, Tennessee, 38301
- Recruiting
Rasai Research
Jackson Heights, New York, 11372
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
- Recruiting
Nsc Research
Johns Creek, Georgia, 30024
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
- Recruiting
Tcr Institute Llc
Kingwood, Texas, 77339
- Recruiting
ClinCept, LLC
Kinston, North Carolina, 28501
- Terminated
Alliance for Multispecialty Research Knoxville
Knoxville, Tennessee, 37909
- Recruiting
University of California San Diego
La Jolla, California, 92037
- Recruiting
East Coast Institute for Research, LLC
Lake City, Florida, 32055
- Recruiting
Capitol Cardiology Associates
Lanham, Maryland, 20706
- Recruiting
Excel Clinical Research
Las Vegas, Nevada, 89109
- Recruiting
American Institute of Medical Research
Las Vegas, Nevada, 89123
- Recruiting
Georgia Clinical Research
Lawrenceville, Georgia, 30044
- Recruiting
Alpine Research Organization
Layton, Utah, 84041
- Recruiting
Virginia Heart - Loudoun
Leesburg, Virginia, 20176
- Recruiting
Epic Clinical Research
Lewisville, Texas, 75057
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
- Recruiting
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
- Recruiting
Nexgen Research
Lima, Ohio, 45801
- Recruiting
Bryan Heart
Lincoln, Nebraska, 68506
- Recruiting
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
- Recruiting
New Jersey Medcare / New Jersey Heart
Linden, New Jersey, 07036
- Recruiting
Walker Family Care
Little River, South Carolina, 29566
- Recruiting
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204
- Recruiting
South Denver Cardiology Associates
Littleton, Colorado, 80120
- Recruiting
InvivoCure
Los Angeles, California, 91405
- Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
- Recruiting
Carient Heart and Vascular
Manassas, Virginia, 20109
- Recruiting
Health East Cancer Care
Maplewood, Minnesota, 55109
- Recruiting
K and R Research
Marion, Ohio, 43302
- Terminated
North Dallas Research Associates
McKinney, Texas, 75069
- Recruiting
Revival Research Institute
McKinney, Texas, 75071
- Recruiting
Texas Institute of Cardiology
McKinney, Texas, 75071
- Recruiting
St Lukes Idaho
Meridian, Idaho, 83642
- Terminated
Solaris Clinical Research
Meridian, Idaho, 83646
- Recruiting
Southern Endocrinology Associates PA
Mesquite, Texas, 75149
- Recruiting
Columbus Clinical Services LLC
Miami, Florida, 33125
- Recruiting
Kendall South Medical Center
Miami, Florida, 33175
- Recruiting
Inpatient Research Clinic, LLC
Miami Lakes, Florida, 33014
- Recruiting
Panax Clinical Research
Miami Lakes, Florida, 33014
- Recruiting
Indago Research and Health Center
Miami Lakes, Florida, 33016
- Recruiting
MyMichigan Medical Center Midland - Clinical Research Department
Midland, Michigan, 48670
- Recruiting
Bon Secours Cardiology
Midlothian, Virginia, 23114
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Eminat, LLC
Miramar, Florida, 33027
- Recruiting
CB Flock Research Corporation
Mobile, Alabama, 36608
- Recruiting
IMA Clinical Research
Monroe, Louisiana, 71201
- Recruiting
Crystal Run Healthcare
Monroe, New York, 10950
- Recruiting
Monroe Biomedical Research
Monroe, North Carolina, 28112
- Recruiting
Accellacare Charleston
Mt. Pleasant, South Carolina, 29464
- Recruiting
Cardiovascular Research of Northwest Indiana LLC
Munster, Indiana, 46321
- Recruiting
Ascension Saint Thomas
Nashville, Tennessee, 37205
- Recruiting
Suncoast Clinical Research Inc
New Port Richey, Florida, 34652
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
Mount Sinai Queens
New York, New York, 10029
- Terminated
Ima Clinical Research Manhattan
New York, New York, 10036
- Recruiting
Saint Michaels Medical Center
Newark, New Jersey, 07102
- Recruiting
Tidewater Physicians Multispecialty Group Clinical Research
Newport News, Virginia, 23606
- Recruiting
Niagara Falls Memorial Medical Center
Niagara Falls, New York, 14304
- Recruiting
Alliance for Multispecialty Research Norfolk
Norfolk, Virginia, 23502
- Recruiting
Alliance for Multispecialty Research
Norman, Oklahoma, 73069
- Recruiting
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
- Recruiting
Valley Clinical Trials
Northridge, California, 91325
- Recruiting
Parkway Cardiology Associates
Oak Ridge, Tennessee, 37830
- Recruiting
Ocala Cardiovascular Research
Ocala, Florida, 34471
- Recruiting
Ocala Research Institute, Inc
Ocala, Florida, 34474
- Recruiting
MedStar Health Research Institute
Olney, Maryland, 20832
- Recruiting
Circuit Clinical Orchard Park Family Practice
Orchard Park, New York, 14127
- Recruiting
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174
- Recruiting
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
- Recruiting
Alliance for Multispecialty Research LLC - Park Ridge
Park Ridge, Illinois, 66068
- Recruiting
Orion Medical
Pasadena, Texas, 77505
- Recruiting
Baptist Health Care
Pensacola, Florida, 32503
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Phoenix Clinical
Phoenix, Arizona, 85014
- Recruiting
Elite Clinical Studies LLC
Phoenix, Arizona, 85018
- Recruiting
Hero Clinical Research
Phoenix, Arizona, 85021
- Recruiting
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15236
- Recruiting
Valley Institute of Research Plano
Plano, Texas, 75024
- Recruiting
Denali Health Plant City
Plant City, Florida, 33563
- Recruiting
Pottstown Medical Specialists Inc
Pottstown, Pennsylvania, 19464
- Recruiting
Hudson Valley Cardiovascular Physicians PC
Poughkeepsie, New York, 12601
- Recruiting
Monument Health Clinical Research
Rapid City, South Dakota, 57701
- Recruiting
Renown Institute for Heart and Vascular Health
Reno, Nevada, 89502
- Recruiting
Rainier Clinical Research Center
Renton, Washington, 98057
- Recruiting
Reid Physician Associates
Richmond, Indiana, 47374
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Advanced Cardiology Associates
Rochester Hills, Michigan, 48307
- Recruiting
Clinical Trials Research - Sacramento
Roseville, California, 95661
- Recruiting
Methodist Hospital
Saint Louis Park, Minnesota, 55426
- Recruiting
Ima Clinical Research San Antonio
San Antonio, Texas, 78229
- Recruiting
Alliance Clinical Research
San Diego, California, 92120
- Recruiting
St Davids Heart & Vascular PLLC dba Austin Heart
San Marcos, Texas, 78666
- Recruiting
Saratoga Clinical Research, LLC
Saratoga Springs, New York, 12866
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
- Recruiting
Circuit Clinical / Optum Medical Care of New Jersey
Secaucus, New Jersey, 07094
- Recruiting
The Heart House - Washington Township
Sewell, New Jersey, 08080
- Recruiting
Louisiana Heart Center
Slidell, Louisiana, 70458
- Recruiting
CardioMetabolic Collaborative Clinic
Somerset, New Jersey, 08873
- Recruiting
Revival Research Institute
Southfield, Michigan, 48034
- Recruiting
Tribe Clinical Research - Spartanburg
Spartanburg, South Carolina, 29301
- Recruiting
Encompass Clinical Research
Spring Valley, California, 91978
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
Stanford Health Care
Stanford, California, 94305
- Recruiting
Piedmont Healthcare
Statesville, North Carolina, 28625
- Recruiting
Manshadi Heart Institute
Stockton, California, 95204
- Recruiting
Centricity Research
Suffolk, Virginia, 23435
- Terminated
FWD Clinical Research
Tamarac, Florida, 33321
- Recruiting
Eclipse Clinical Research
Tucson, Arizona, 85745
- Recruiting
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388
- Recruiting
Cardiology Associates Research LLC
Tupelo, Mississippi, 38801
- Recruiting
Tyler Cardiovascular Consultants
Tyler, Texas, 75701
- Recruiting
Blue Coast Cardiology
Vista, California, 92083
- Recruiting
Diablo Clinical Research
Walnut Creek, California, 94598
- Recruiting
Ima Clinical Research - Warren
Warren Township, New Jersey, 07059
- Recruiting
Chase Medical Research LLC
Waterbury, Connecticut, 06708
- Recruiting
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50266
- Recruiting
Focus Clinical Research
West Hills, California, 91307
- Recruiting
Interventional Cardiology Medical Group
West Hills, California, 91307
- Recruiting
Monroe Research LLC
West Monroe, Louisiana, 71291
- Recruiting
Accellacare Research of Wilmington
Wilmington, North Carolina, 28401
- Recruiting
Selma Medical Associates
Winchester, Virginia, 22601
- Terminated
Winchester Medical Center
Winchester, Virginia, 22601
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
- Recruiting
Clinical Site Partners Orlando dba Flourish Research
Winter Park, Florida, 32789
- Terminated
Guardian Research Organization LLC
Winter Park, Florida, 32792
- Recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
Canada25 sites, 24 recruiting
- Recruiting
Centricity Research Brampton
Brampton, Ontario, L6S 0C6
- Recruiting
Circulate Cardiac & Vascular Centre
Burlington, Ontario, L7M 1K9
- Recruiting
Centricity Research Calgary
Calgary, Alberta, T2H 2G4
- Recruiting
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
- Recruiting
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
- Recruiting
Edmonton Cardiology Consultants
Edmonton, Alberta, T5H 4B9
- Recruiting
Hamilton Health Sciences Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
- Completed
Premier Clinical Trial Network
Hamilton, Ontario, L8L 5G4
- Recruiting
St Josephs Hospital
London, Ontario, N6A 4V2
- Recruiting
Elevate Clinical Research KMH Missisauga
Mississauga, Ontario, L5K 2L3
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
- Recruiting
Institut de recherches cliniques de Montreal
Montreal, Quebec, H2W 1R7
- Recruiting
Centre de Recherche du Centre Hospitalier de l Universite de Montreal
Montreal, Quebec, H2W 1T8
- Recruiting
Research Institute of McGill University Health Center - Glen Site
Montreal, Quebec, H4A 3J1
- Recruiting
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4
- Recruiting
Partners in Advanced Cardiac Evaluation
Newmarket, Ontario, L3Y 8C3
- Recruiting
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7
- Recruiting
Oakville Cardiovascular Research
Oakville, Ontario, L6K 3W7
- Recruiting
Heart Health Institute Research Incorporated
Scarborough Village, Ontario, M1B 4Z8
- Recruiting
CIUSSS de l Estrie CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
- Recruiting
SMH Cardiology Clinical Trials Incorporated
Surrey, British Columbia, V3V 0C6
- Recruiting
Womens College Hospital
Toronto, Ontario, M5S 1B2
- Recruiting
ARC Biosystems Incorporated
Vancouver, British Columbia, V6Z 1Y6
- Recruiting
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 1B2
- Recruiting
Discovery Clinical Services Ltd
Victoria, British Columbia, V8T 5G4
Australia22 sites, 22 recruiting
- Recruiting
Advara HeartCare Wesley
Auchenflower, Queensland, 4066
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
- Recruiting
Novatrials
Charlestown, New South Wales, 2290
- Recruiting
Victorian Heart Hospital
Clayton, Victoria, 3168
- Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, 2139
- Recruiting
Canberra Hospital
Garran, Australian Capital Territory, 2605
- Recruiting
Clinitrials - Mandurah
Greenfields, Western Australia, 6210
- Recruiting
Advara HeartCare Joondalup
Joondalup, Western Australia, 6027
- Recruiting
Advara HeartCare Leabrook
Leabrook, South Australia, 5068
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Momentum Clinical Research - Sunshine
Melbourne, Victoria, 3021
- Recruiting
Aim Research
Merewether, New South Wales, 2291
- Recruiting
Core Research Group Pty Ltd
Milton, Queensland, 4064
- Recruiting
Hollywood Private Hospital
Nedlands, Western Australia, 6009
- Recruiting
Linear Clinical Research Limited
Nedlands, Western Australia, 6009
- Recruiting
Fusion Clinical Research
Norwood, South Australia, 5067
- Recruiting
Orange Health Service
Orange, New South Wales, 2800
- Recruiting
Clinitrials - West Perth
Perth, Western Australia, 6000
- Recruiting
University of The Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, 4556
- Recruiting
Wollongong Hospital
Wollongong, New South Wales, 2500
- Recruiting
Dr Heart Pty Ltd
Woolloongabba, Queensland, 4102
About this study
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)
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]).
- Conditions
- Cardiovascular Disease
- Being tested
- Olpasiran, Placebo
- Keywords
- Olpasiran, AMG 890, Coronary heart disease, CHD, Myocardial infarction, Coronary revascularization
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlpasiranDrug
Also called AMG 890
Olpasiran will be administered via SC injection.
PlaceboDrug
Placebo will be administered via SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Olpasiran | Experimental | Participants will receive subcutaneous (SC) olpasiran. Receives: Drug: Olpasiran |
| Placebo | Placebo comparator | Participants will receive SC placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
Measured: Up to approximately 6.2 years
Secondary outcomes (13)
Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First
Measured: Up to approximately 6.2 years
Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First
Measured: Up to approximately 6.2 years
Percent Change From Baseline to Week 48 Lp(a) Levels
Measured: Baseline and Week 48
Time to Myocardial Infarction
Measured: Up to approximately 6.2 years
Time to CHD Death or Myocardial Infarction, Whichever Occurs First
Measured: Up to approximately 6.2 years
Time to Urgent Coronary Revascularization
Measured: Up to approximately 6.2 years
Time to Coronary Revascularization
Measured: Up to approximately 6.2 years
Time to CHD Death
Measured: Up to approximately 6.2 years
Time to Cardiovascular Death
Measured: Up to approximately 6.2 years
Time to Death by any Cause
Measured: Up to approximately 6.2 years
Time to Ischemic Stroke
Measured: Up to approximately 6.2 years
Serum Concentration of Olpasiran
Measured: Up to Week 48
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Including serious adverse events and adverse events leading to discontinuation of investigational product.
Measured: Up to approximately 6.2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start22 Aug 2025
- Primary completion20 Oct 2031 (estimated)
- Study completion20 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136012
- Sponsor's protocol ID
- 20230222
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07136012
- Acronym / sponsor ID
- 20230222
- Conditions
- Cardiovascular Disease
- Keywords
- Olpasiran, AMG 890, Coronary heart disease, CHD, Myocardial infarction, Coronary revascularization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 20 Oct 2031 (estimated)
- Study completion
- 20 Oct 2031 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olpasiran | Experimental | Drug: OlpasiranParticipants will receive subcutaneous (SC) olpasiran. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive SC placebo. |
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥50 years
- Lp(a)≥ 200 nmol/L during screening
- Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
Key exclusion criteria (3 listed)
- Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
- Prior or planned arterial revascularization
- History of major bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlpasiranAlso: AMG 890Olpasiran will be administered via SC injection. | Drug | Olpasiran |
| PlaceboPlacebo will be administered via SC injection. | Drug | Placebo |
Primary outcome
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
Time frame: Up to approximately 6.2 years
13 secondary outcomes
Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First
Time frame: Up to approximately 6.2 years
Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First
Time frame: Up to approximately 6.2 years
Percent Change From Baseline to Week 48 Lp(a) Levels
Time frame: Baseline and Week 48
Time to Myocardial Infarction
Time frame: Up to approximately 6.2 years
Time to CHD Death or Myocardial Infarction, Whichever Occurs First
Time frame: Up to approximately 6.2 years
Time to Urgent Coronary Revascularization
Time frame: Up to approximately 6.2 years
Time to Coronary Revascularization
Time frame: Up to approximately 6.2 years
Time to CHD Death
Time frame: Up to approximately 6.2 years
Time to Cardiovascular Death
Time frame: Up to approximately 6.2 years
Time to Death by any Cause
Time frame: Up to approximately 6.2 years
Time to Ischemic Stroke
Time frame: Up to approximately 6.2 years
Serum Concentration of Olpasiran
Time frame: Up to Week 48
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 6.2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
252 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olpasiran in people with Cardiovascular Disease, run by Amgen at 252 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 252 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First (time frame: Up to approximately 6.2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.