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

NCT ID: NCT07136012

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

11000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-22

Study Completion Date

2031-10-20

Brief Summary

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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\[a\]).

Detailed Description

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Conditions

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Cardiovascular Disease

Keywords

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Olpasiran AMG 890 Coronary heart disease CHD Myocardial infarction Coronary revascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Olpasiran

Participants will receive subcutaneous (SC) olpasiran.

Group Type EXPERIMENTAL

Olpasiran

Intervention Type DRUG

Olpasiran will be administered via SC injection.

Placebo

Participants will receive SC placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered via SC injection.

Interventions

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Olpasiran

Olpasiran will be administered via SC injection.

Intervention Type DRUG

Placebo

Placebo will be administered via SC injection.

Intervention Type DRUG

Other Intervention Names

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AMG 890

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

50 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Advanced Cardiovascular LLC

Alexander City, Alabama, United States

Site Status RECRUITING

Alliance For Multispecialty Research - Daphne

Daphne, Alabama, United States

Site Status RECRUITING

Eastern Shore Research Institute

Fairhope, Alabama, United States

Site Status RECRUITING

Heart Center Research LLC

Huntsville, Alabama, United States

Site Status RECRUITING

CB Flock Research Corporation

Mobile, Alabama, United States

Site Status RECRUITING

Phoenix Clinical

Phoenix, Arizona, United States

Site Status RECRUITING

Elite Clinical Studies LLC

Phoenix, Arizona, United States

Site Status RECRUITING

HonorHealth Research Institute

Scottsdale, Arizona, United States

Site Status RECRUITING

Eclipse Clinical Research

Tucson, Arizona, United States

Site Status RECRUITING

National Heart Institute

Beverly Hills, California, United States

Site Status RECRUITING

310 Clinical Research

Inglewood, California, United States

Site Status RECRUITING

Valley Clinical Trials

Northridge, California, United States

Site Status RECRUITING

Clinical Trials Research - Sacramento

Roseville, California, United States

Site Status RECRUITING

Alliance Clinical Research

San Diego, California, United States

Site Status RECRUITING

Encompass Clinical Research

Spring Valley, California, United States

Site Status RECRUITING

Manshadi Heart Institute

Stockton, California, United States

Site Status RECRUITING

Blue Coast Cardiology

Vista, California, United States

Site Status RECRUITING

Diablo Clinical Research

Walnut Creek, California, United States

Site Status RECRUITING

Focus Clinical Research

West Hills, California, United States

Site Status RECRUITING

South Denver Cardiology Associates

Littleton, Colorado, United States

Site Status RECRUITING

Chase Medical Research LLC

Waterbury, Connecticut, United States

Site Status RECRUITING

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Site Status RECRUITING

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Site Status RECRUITING

Proactive Clinical Research

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Indago Research and Health Center

Hialeah, Florida, United States

Site Status RECRUITING

Elite Cardiac Research Center LLC

Hialeah, Florida, United States

Site Status RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status RECRUITING

East Coast Institute for Research, LLC

Lake City, Florida, United States

Site Status RECRUITING

Columbus Clinical Services LLC

Miami, Florida, United States

Site Status RECRUITING

Kendall South Medical Center

Miami, Florida, United States

Site Status RECRUITING

Inpatient Research Clinic, LLC

Miami Lakes, Florida, United States

Site Status RECRUITING

Panax Clinical Research

Miami Lakes, Florida, United States

Site Status RECRUITING

Eminat, LLC

Miramar, Florida, United States

Site Status RECRUITING

Suncoast Clinical Research Inc

New Port Richey, Florida, United States

Site Status RECRUITING

Ocala Cardiovascular Research

Ocala, Florida, United States

Site Status RECRUITING

Ocala Research Institute, Inc

Ocala, Florida, United States

Site Status RECRUITING

Ormond Beach Clinical Research

Ormond Beach, Florida, United States

Site Status RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

East Coast Institute for Research

Canton, Georgia, United States

Site Status RECRUITING

Nsc Research

Johns Creek, Georgia, United States

Site Status RECRUITING

St Lukes Idaho Cardiology Associates

Meridian, Idaho, United States

Site Status RECRUITING

Solaris Clinical Research

Meridian, Idaho, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC - Park Ridge

Park Ridge, Illinois, United States

Site Status RECRUITING

MediSphere Medical Research Center LLC

Evansville, Indiana, United States

Site Status RECRUITING

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Site Status RECRUITING

Cardiovascular Research of Northwest Indiana LLC

Munster, Indiana, United States

Site Status RECRUITING

Reid Physician Associates

Richmond, Indiana, United States

Site Status RECRUITING

Hutchinson Clinic PA

Hutchinson, Kansas, United States

Site Status RECRUITING

Midwest Heart and Vascular Specialists

Overland Park, Kansas, United States

Site Status RECRUITING

Graves Gilbert Clinic

Bowling Green, Kentucky, United States

Site Status RECRUITING

The Research Group of Lexington LLC

Lexington, Kentucky, United States

Site Status RECRUITING

Ima Clinical Research

Monroe, Louisiana, United States

Site Status RECRUITING

Louisiana Heart Center

Slidell, Louisiana, United States

Site Status RECRUITING

Monroe Research LLC

West Monroe, Louisiana, United States

Site Status RECRUITING

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Metropolitan Cardiovascular Consultants LLC

Beltsville, Maryland, United States

Site Status RECRUITING

Flourish Research

Bowie, Maryland, United States

Site Status RECRUITING

Centennial Medical Group

Columbia, Maryland, United States

Site Status RECRUITING

Capitol Cardiology Associates

Lanham, Maryland, United States

Site Status RECRUITING

Advanced Cardiology Associates

Rochester Hills, Michigan, United States

Site Status RECRUITING

Revival Research Institute

Southfield, Michigan, United States

Site Status RECRUITING

Sisters of Saint Mary Health Heart and Vascular Care

Bridgeton, Missouri, United States

Site Status RECRUITING

Excel Clinical Research

Las Vegas, Nevada, United States

Site Status RECRUITING

American Institute of Medical Research

Las Vegas, Nevada, United States

Site Status RECRUITING

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Site Status RECRUITING

Renown Institute for Heart and Vascular Health

Reno, Nevada, United States

Site Status RECRUITING

New Jersey Medcare / New Jersey Heart

Linden, New Jersey, United States

Site Status RECRUITING

Circuit Clinical / Optum Medical Care of New Jersey

Secaucus, New Jersey, United States

Site Status RECRUITING

CardioMetabolic Collaborative Clinic

Somerset, New Jersey, United States

Site Status RECRUITING

Ima Clinical Research - Warren

Warren Township, New Jersey, United States

Site Status RECRUITING

Albany Medical College

Albany, New York, United States

Site Status RECRUITING

Crystal Run Healthcare

Monroe, New York, United States

Site Status RECRUITING

Niagara Falls Memorial Medical Center

Niagara Falls, New York, United States

Site Status RECRUITING

Orchard Park Family Pracitce

Orchard Park, New York, United States

Site Status RECRUITING

Medication Management LLC

Greensboro, North Carolina, United States

Site Status RECRUITING

Triad Clinical Trials, LLC

Greensboro, North Carolina, United States

Site Status RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, United States

Site Status RECRUITING

Accellacare Research of Wilmington

Wilmington, North Carolina, United States

Site Status RECRUITING

Aultman Cardiology Clinical Trials

Canton, Ohio, United States

Site Status RECRUITING

The Christ Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Nexgen Research

Lima, Ohio, United States

Site Status RECRUITING

K and R Research

Marion, Ohio, United States

Site Status RECRUITING

Alliance for Multispecialty Research

Norman, Oklahoma, United States

Site Status RECRUITING

Pottstown Medical Specialists Inc

Pottstown, Pennsylvania, United States

Site Status RECRUITING

Pharmacorp Clinical Trials Inc

Charleston, South Carolina, United States

Site Status RECRUITING

Walker Family Care

Little River, South Carolina, United States

Site Status RECRUITING

Accellacare Charleston

Mt. Pleasant, South Carolina, United States

Site Status RECRUITING

Tribe Clinical Research - Spartanburg

Spartanburg, South Carolina, United States

Site Status RECRUITING

Apex Research Foundation, LLC

Jackson, Tennessee, United States

Site Status RECRUITING

Alliance for Multispecialty Research Knoxville

Knoxville, Tennessee, United States

Site Status RECRUITING

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

Site Status RECRUITING

PharmaTex Research, LLC

Amarillo, Texas, United States

Site Status RECRUITING

Texas Diabetes and Endocrinology

Austin, Texas, United States

Site Status RECRUITING

Ima Clinical Research

Austin, Texas, United States

Site Status RECRUITING

Zenos Clinical Research

Dallas, Texas, United States

Site Status RECRUITING

Cedar Health Research, LLC

Euless, Texas, United States

Site Status RECRUITING

East Texas Cardiology PA

Houston, Texas, United States

Site Status RECRUITING

Cardiovascular Specialists of Willowbrook

Houston, Texas, United States

Site Status RECRUITING

Vital Heart and Vein

Humble, Texas, United States

Site Status RECRUITING

Tcr Institute Llc

Kingwood, Texas, United States

Site Status RECRUITING

Epic Clinical Research

Lewisville, Texas, United States

Site Status RECRUITING

North Dallas Research Associates

McKinney, Texas, United States

Site Status RECRUITING

Texas Institute of Cardiology

McKinney, Texas, United States

Site Status RECRUITING

Southern Endocrinology Associates PA

Mesquite, Texas, United States

Site Status RECRUITING

Orion Medical

Pasadena, Texas, United States

Site Status RECRUITING

Ima Clinical Research San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Site Status RECRUITING

Carient Heart and Vascular

Manassas, Virginia, United States

Site Status RECRUITING

Tidewater Physicians Multispecialty Group Clinical Research

Newport News, Virginia, United States

Site Status RECRUITING

Alliance for Multispecialty Research Norfolk

Norfolk, Virginia, United States

Site Status RECRUITING

Centricity Research

Suffolk, Virginia, United States

Site Status RECRUITING

Selma Medical Associates

Winchester, Virginia, United States

Site Status RECRUITING

Winchester Medical Center

Winchester, Virginia, United States

Site Status RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status RECRUITING

Novatrials

Charlestown, New South Wales, Australia

Site Status RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Site Status RECRUITING

Aim Research

Merewether, New South Wales, Australia

Site Status RECRUITING

Orange Health Service

Orange, New South Wales, Australia

Site Status RECRUITING

Advara HeartCare Wesley

Auchenflower, Queensland, Australia

Site Status RECRUITING

Core Research Group Pty Ltd

Milton, Queensland, Australia

Site Status RECRUITING

University of The Sunshine Coast Clinical Trials, Sippy Downs

Sippy Downs, Queensland, Australia

Site Status RECRUITING

Dr Heart Pty Ltd

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status RECRUITING

Advara HeartCare Leabrook

Leabrook, South Australia, Australia

Site Status RECRUITING

Fusion Clinical Research

Norwood, South Australia, Australia

Site Status RECRUITING

Victorian Heart Hospital

Clayton, Victoria, Australia

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Momentum Clinical Research - Sunshine

Melbourne, Victoria, Australia

Site Status RECRUITING

Advara HeartCare Joondalup

Joondalup, Western Australia, Australia

Site Status RECRUITING

Linear Clinical Research Limited

Nedlands, Western Australia, Australia

Site Status RECRUITING

Centricity Research Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

Fraser Clinical Trials

New Westminster, British Columbia, Canada

Site Status RECRUITING

SMH Cardiology Clinical Trials Incorporated

Surrey, British Columbia, Canada

Site Status RECRUITING

ARC Biosystems Incorporated

Vancouver, British Columbia, Canada

Site Status RECRUITING

Discovery Clinical Services Ltd

Victoria, British Columbia, Canada

Site Status RECRUITING

Centricity Research Brampton

Brampton, Ontario, Canada

Site Status RECRUITING

Premier Clinical Trial Network

Hamilton, Ontario, Canada

Site Status RECRUITING

Partners in Advanced Cardiac Evaluation

Newmarket, Ontario, Canada

Site Status RECRUITING

North York Diagnostic and Cardiac Centre

North York, Ontario, Canada

Site Status RECRUITING

Oakville Cardiovascular Research

Oakville, Ontario, Canada

Site Status RECRUITING

Heart Health Institute Research Incorporated

Scarborough Village, Ontario, Canada

Site Status RECRUITING

Ecogene-21

Chicoutimi, Quebec, Canada

Site Status RECRUITING

CIUSSS de l Estrie CHUS Hopital Fleurimont

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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United States Australia Canada

Central Contacts

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Amgen Call Center

Role: CONTACT

Phone: 866-572-6436

Email: [email protected]

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20230222

Identifier Type: -

Identifier Source: org_study_id