RecruitingPhase 3NCT07136012

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)


Sponsor

Amgen

Enrollment

11,000 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

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\[a\]).


Eligibility

Min Age: 50 YearsMax Age: 105 Years

Inclusion Criteria3

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

Exclusion Criteria3

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

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Interventions

DRUGOlpasiran

Olpasiran will be administered via SC injection.

DRUGPlacebo

Placebo will be administered via SC injection.


Locations(238)

Advanced Cardiovascular LLC

Alexander City, Alabama, United States

University of Alabama Birmingham Saint Vincents Birmingham

Birmingham, Alabama, United States

Birmingham Clinical Research

Birmingham, Alabama, United States

Alliance For Multispecialty Research - Daphne

Daphne, Alabama, United States

Eastern Shore Research Institute

Fairhope, Alabama, United States

Heart Center Research LLC

Huntsville, Alabama, United States

CB Flock Research Corporation

Mobile, Alabama, United States

Phoenix Clinical

Phoenix, Arizona, United States

Elite Clinical Studies LLC

Phoenix, Arizona, United States

Hero Clinical Research

Phoenix, Arizona, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

Eclipse Clinical Research

Tucson, Arizona, United States

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

National Heart Institute

Beverly Hills, California, United States

310 Clinical Research

Inglewood, California, United States

University of California San Diego

La Jolla, California, United States

InvivoCure

Los Angeles, California, United States

Valley Clinical Trials

Northridge, California, United States

Clinical Trials Research - Sacramento

Roseville, California, United States

Alliance Clinical Research

San Diego, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Stanford Health Care

Stanford, California, United States

Manshadi Heart Institute

Stockton, California, United States

Blue Coast Cardiology

Vista, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Focus Clinical Research

West Hills, California, United States

Interventional Cardiology Medical Group

West Hills, California, United States

UCHealth Memorial Central

Colorado Springs, Colorado, United States

South Denver Cardiology Associates

Littleton, Colorado, United States

Gandelman Cardiology, PC

Greenwich, Connecticut, United States

ClinTrial Hamden

Hamden, Connecticut, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Proactive Clinical Research

Fort Lauderdale, Florida, United States

Indago Research and Health Center

Hialeah, Florida, United States

Elite Cardiac Research Center LLC

Hialeah, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

East Coast Institute for Research, LLC

Lake City, Florida, United States

Columbus Clinical Services LLC

Miami, Florida, United States

Kendall South Medical Center

Miami, Florida, United States

Inpatient Research Clinic, LLC

Miami Lakes, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Eminat, LLC

Miramar, Florida, United States

Suncoast Clinical Research Inc

New Port Richey, Florida, United States

Ocala Cardiovascular Research

Ocala, Florida, United States

Ocala Research Institute, Inc

Ocala, Florida, United States

Ormond Beach Clinical Research

Ormond Beach, Florida, United States

Baptist Health Care

Pensacola, Florida, United States

Denali Health Plant City

Plant City, Florida, United States

FWD Clinical Research

Tamarac, Florida, United States

Guardian Research Organization LLC

Winter Park, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

East Coast Institute for Research

Canton, Georgia, United States

Northeast Georgia Medical Center Wisteria Building

Cumming, Georgia, United States

Nsc Research

Johns Creek, Georgia, United States

Georgia Clinical Research

Lawrenceville, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

St Lukes Idaho Cardiology Associates

Meridian, Idaho, United States

Solaris Clinical Research

Meridian, Idaho, United States

Endeavor Health-Northwest Community Healthcare

Arlington Heights, Illinois, United States

Christie Clinic

Champaign, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Alliance for Multispecialty Research, LLC - Park Ridge

Park Ridge, Illinois, United States

MediSphere Medical Research Center LLC

Evansville, Indiana, United States

Parkview Research Center

Fort Wayne, Indiana, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Ascension Saint Vincent Heart Center

Indianapolis, Indiana, United States

Cardiovascular Research of Northwest Indiana LLC

Munster, Indiana, United States

Reid Physician Associates

Richmond, Indiana, United States

MercyOne Iowa Heart Center

West Des Moines, Iowa, United States

Hutchinson Clinic PA

Hutchinson, Kansas, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Midwest Heart and Vascular Specialists

Overland Park, Kansas, United States

Graves Gilbert Clinic

Bowling Green, Kentucky, United States

The Research Group of Lexington LLC

Lexington, Kentucky, United States

Heart Clinic of Hammond

Covington, Louisiana, United States

Ima Clinical Research

Monroe, Louisiana, United States

Louisiana Heart Center

Slidell, Louisiana, United States

Monroe Research LLC

West Monroe, Louisiana, United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Metropolitan Cardiovascular Consultants LLC

Beltsville, Maryland, United States

Suburban Hospital

Bethesda, Maryland, United States

Flourish Research

Bowie, Maryland, United States

Johns Hopkins University

Columbia, Maryland, United States

Centennial Medical Group

Columbia, Maryland, United States

Medstar Franklin Square Medical Center

Hyattsville, Maryland, United States

Capitol Cardiology Associates

Lanham, Maryland, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Healthy Heart Cardiology

Grand Rapids, Michigan, United States

MyMichigan Medical Center Midland - Clinical Research Department

Midland, Michigan, United States

Advanced Cardiology Associates

Rochester Hills, Michigan, United States

Revival Research Institute

Southfield, Michigan, United States

Health East Cancer Care

Maplewood, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Methodist Hospital

Saint Louis Park, Minnesota, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Cardiology Associates Research LLC

Tupelo, Mississippi, United States

Sisters of Saint Mary Health Heart and Vascular Care

Bridgeton, Missouri, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

Bryan Heart

Lincoln, Nebraska, United States

Excel Clinical Research

Las Vegas, Nevada, United States

American Institute of Medical Research

Las Vegas, Nevada, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Renown Institute for Heart and Vascular Health

Reno, Nevada, United States

Advanced Heart and Vascular Institute of Hunterdon

Flemington, New Jersey, United States

Clinical Reseach Philadelphia Pennington

Hamilton, New Jersey, United States

Med Clinical Research Partners - Irvington

Irvington, New Jersey, United States

New Jersey Medcare / New Jersey Heart

Linden, New Jersey, United States

Saint Michaels Medical Center

Newark, New Jersey, United States

Circuit Clinical / Optum Medical Care of New Jersey

Secaucus, New Jersey, United States

The Heart House - Washington Township

Sewell, New Jersey, United States

CardioMetabolic Collaborative Clinic

Somerset, New Jersey, United States

Ima Clinical Research - Warren

Warren Township, New Jersey, United States

Albany Medical College

Albany, New York, United States

Basil Clinical

Inwood, New York, United States

Rasai Research

Jackson Heights, New York, United States

Crystal Run Healthcare

Monroe, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Mount Sinai Queens

New York, New York, United States

Ima Clinical Research Manhattan

New York, New York, United States

Niagara Falls Memorial Medical Center

Niagara Falls, New York, United States

Circuit Clinical Orchard Park Family Practice

Orchard Park, New York, United States

Hudson Valley Cardiovascular Physicians PC

Poughkeepsie, New York, United States

Saratoga Clinical Research, LLC

Saratoga Springs, New York, United States

Moses H Cone Memorial Hospital

Greensboro, North Carolina, United States

Medication Management LLC

Greensboro, North Carolina, United States

Triad Clinical Trials, LLC

Greensboro, North Carolina, United States

ClinCept, LLC

Kinston, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Piedmont Healthcare

Statesville, North Carolina, United States

Accellacare Research of Wilmington

Wilmington, North Carolina, United States

Aultman Cardiology Clinical Trials

Canton, Ohio, United States

The Christ Hospital

Cincinnati, Ohio, United States

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, United States

Nexgen Research

Lima, Ohio, United States

K and R Research

Marion, Ohio, United States

Alliance for Multispecialty Research

Norman, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Preferred Primary Care Physicians, Inc

Pittsburgh, Pennsylvania, United States

Pottstown Medical Specialists Inc

Pottstown, Pennsylvania, United States

Pharmacorp Clinical Trials Inc

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health Carolina Cardiology - Greenville

Gantt, South Carolina, United States

Walker Family Care

Little River, South Carolina, United States

Accellacare Charleston

Mt. Pleasant, South Carolina, United States

Tribe Clinical Research - Spartanburg

Spartanburg, South Carolina, United States

Monument Health Clinical Research

Rapid City, South Dakota, United States

Erlanger Health, Inc.

Chattanooga, Tennessee, United States

Apex Research Foundation, LLC

Jackson, Tennessee, United States

Alliance for Multispecialty Research Knoxville

Knoxville, Tennessee, United States

Ascension Saint Thomas

Nashville, Tennessee, United States

Parkway Cardiology Associates

Oak Ridge, Tennessee, United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

PharmaTex Research, LLC

Amarillo, Texas, United States

Texas Diabetes and Endocrinology

Austin, Texas, United States

Ima Clinical Research

Austin, Texas, United States

Pioneer Medical Associates

Carrollton, Texas, United States

Baylor Scott and White Heart and Vascular Hospital-Dallas

Dallas, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

The Heartbeat Clinic

Dallas, Texas, United States

Cedar Health Research, LLC

Dallas, Texas, United States

Cedar Health Research, LLC

Euless, Texas, United States

East Texas Cardiology PA

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Cardiovascular Specialists of Willowbrook

Houston, Texas, United States

Vital Heart and Vein

Humble, Texas, United States

Tcr Institute Llc

Kingwood, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

North Dallas Research Associates

McKinney, Texas, United States

Revival Research Institute

McKinney, Texas, United States

Texas Institute of Cardiology

McKinney, Texas, United States

Southern Endocrinology Associates PA

Mesquite, Texas, United States

Orion Medical

Pasadena, Texas, United States

Valley Institute of Research Plano

Plano, Texas, United States

Ima Clinical Research San Antonio

San Antonio, Texas, United States

St Davids Heart & Vascular PLLC dba Austin Heart

San Marcos, Texas, United States

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Alpine Research Organization

Layton, Utah, United States

Inova Cardiology - Fairfax

Fairfax, Virginia, United States

Virginia Heart

Falls Church, Virginia, United States

Virginia Heart - Loudoun

Leesburg, Virginia, United States

Carient Heart and Vascular

Manassas, Virginia, United States

Bon Secours Cardiology

Midlothian, Virginia, United States

Tidewater Physicians Multispecialty Group Clinical Research

Newport News, Virginia, United States

Alliance for Multispecialty Research Norfolk

Norfolk, Virginia, United States

Centricity Research

Suffolk, Virginia, United States

Selma Medical Associates

Winchester, Virginia, United States

Winchester Medical Center

Winchester, Virginia, United States

Western Washington Medical Group

Everett, Washington, United States

Rainier Clinical Research Center

Renton, Washington, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Novatrials

Charlestown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Aim Research

Merewether, New South Wales, Australia

Orange Health Service

Orange, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Advara HeartCare Wesley

Auchenflower, Queensland, Australia

Core Research Group Pty Ltd

Milton, Queensland, Australia

University of The Sunshine Coast Clinical Trials, Sippy Downs

Sippy Downs, Queensland, Australia

Dr Heart Pty Ltd

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Advara HeartCare Leabrook

Leabrook, South Australia, Australia

Fusion Clinical Research

Norwood, South Australia, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Momentum Clinical Research - Sunshine

Melbourne, Victoria, Australia

Clinitrials - Mandurah

Greenfields, Western Australia, Australia

Advara HeartCare Joondalup

Joondalup, Western Australia, Australia

Hollywood Private Hospital

Nedlands, Western Australia, Australia

Linear Clinical Research Limited

Nedlands, Western Australia, Australia

Clinitrials - Mount Medical Centre

Perth, Western Australia, Australia

Centricity Research Calgary

Calgary, Alberta, Canada

Edmonton Cardiology Consultants

Edmonton, Alberta, Canada

Fraser Clinical Trials

New Westminster, British Columbia, Canada

SMH Cardiology Clinical Trials Incorporated

Surrey, British Columbia, Canada

ARC Biosystems Incorporated

Vancouver, British Columbia, Canada

Victoria Heart Institute Foundation

Victoria, British Columbia, Canada

Discovery Clinical Services Ltd

Victoria, British Columbia, Canada

Centricity Research Brampton

Brampton, Ontario, Canada

Premier Clinical Trial Network

Hamilton, Ontario, Canada

Elevate Clinical Research KMH Missisauga

Mississauga, Ontario, Canada

Partners in Advanced Cardiac Evaluation

Newmarket, Ontario, Canada

North York Diagnostic and Cardiac Centre

North York, Ontario, Canada

Oakville Cardiovascular Research

Oakville, Ontario, Canada

Heart Health Institute Research Incorporated

Scarborough Village, Ontario, Canada

Ecogene-21

Chicoutimi, Quebec, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Institut de recherches cliniques de Montreal

Montreal, Quebec, Canada

Centre de Recherche du Centre Hospitalier de l Universite de Montreal

Montreal, Quebec, Canada

Research Institute of McGill University Health Center - Glen Site

Montreal, Quebec, Canada

CIUSSS de l Estrie CHUS Hopital Fleurimont

Sherbrooke, Quebec, Canada

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