Dysautonomia International

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

Purpose

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]).

Condition

Cardiovascular Disease

Eligibility

Eligible Ages: Between 50 Years and 105 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Olpasiran	Participants will receive subcutaneous (SC) olpasiran.	Drug: Olpasiran Olpasiran will be administered via SC injection. Other names: AMG 890
Placebo Comparator Placebo	Participants will receive SC placebo.	Drug: Placebo Placebo will be administered via SC injection.

Recruiting Locations

Advanced Cardiovascular LLC
Alexander City 4829843, Alabama 4829764 35010

University of Alabama Birmingham Saint Vincents Birmingham
Birmingham 4049979, Alabama 4829764 35205

Alliance For Multispecialty Research - Daphne
Daphne 4058219, Alabama 4829764 36526

Eastern Shore Research Institute
Fairhope 4061234, Alabama 4829764 36532

Heart Center Research LLC
Huntsville 4068590, Alabama 4829764 35801

CB Flock Research Corporation
Mobile 4076598, Alabama 4829764 36608

Phoenix Clinical
Phoenix 5308655, Arizona 5551752 85014

Elite Clinical Studies LLC
Phoenix 5308655, Arizona 5551752 85018

Hero Clinical Research
Phoenix 5308655, Arizona 5551752 85021

HonorHealth Research Institute
Scottsdale 5313457, Arizona 5551752 85258

Eclipse Clinical Research
Tucson 5318313, Arizona 5551752 85745

Lynn Institute of the Ozarks
Little Rock 4119403, Arkansas 4099753 72204

National Heart Institute
Beverly Hills 5328041, California 5332921 90211

310 Clinical Research
Inglewood 5359488, California 5332921 90301

University of California San Diego
La Jolla 5363943, California 5332921 92037

InvivoCure
Los Angeles 5368361, California 5332921 91405

Valley Clinical Trials
Northridge 5377985, California 5332921 91325

Clinical Trials Research - Sacramento
Roseville 5388881, California 5332921 95661

Encompass Clinical Research
Spring Valley 5398277, California 5332921 91978

Manshadi Heart Institute
Stockton 5399020, California 5332921 95204

Blue Coast Cardiology
Vista 5406602, California 5332921 92083

Diablo Clinical Research
Walnut Creek 5406990, California 5332921 94598

Focus Clinical Research
West Hills 8030162, California 5332921 91307

UCHealth Memorial Central
Colorado Springs 5417598, Colorado 5417618 80909

South Denver Cardiology Associates
Littleton 5429032, Colorado 5417618 80120

Chase Medical Research LLC
Waterbury 4845193, Connecticut 4831725 06708

Excel Medical Clinical Trials
Boca Raton 4148411, Florida 4155751 33434

Clearwater Cardiovascular Consultants
Clearwater 4151316, Florida 4155751 33756

Proactive Clinical Research
Fort Lauderdale 4155966, Florida 4155751 33308

Indago Research and Health Center
Hialeah 4158476, Florida 4155751 33012

Elite Cardiac Research Center LLC
Hialeah 4158476, Florida 4155751 33013

Jacksonville Center for Clinical Research
Jacksonville 4160021, Florida 4155751 32216

East Coast Institute for Research, LLC
Lake City 4161187, Florida 4155751 32055

Columbus Clinical Services LLC
Miami 4164138, Florida 4155751 33125

Kendall South Medical Center
Miami 4164138, Florida 4155751 33175

Inpatient Research Clinic, LLC
Miami Lakes 4164186, Florida 4155751 33014

Panax Clinical Research
Miami Lakes 4164186, Florida 4155751 33014

Eminat, LLC
Miramar 4164601, Florida 4155751 33027

Suncoast Clinical Research Inc
New Port Richey 4165869, Florida 4155751 34652

Ocala Cardiovascular Research
Ocala 4166673, Florida 4155751 34471

Ocala Research Institute, Inc
Ocala 4166673, Florida 4155751 34474

Ormond Beach Clinical Research
Ormond Beach 4167178, Florida 4155751 32174

Baptist Health Care
Pensacola 4168228, Florida 4155751 32514

Denali Health Plant City
Plant City 4168773, Florida 4155751 33563

FWD Clinical Research
Tamarac 4174738, Florida 4155751 33321

Guardian Research Organization LLC
Winter Park 4178560, Florida 4155751 32792

Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322

East Coast Institute for Research
Canton 4186213, Georgia 4197000 30114

Northeast Georgia Medical Center Wisteria Building
Cumming 4190396, Georgia 4197000 30041

Nsc Research
Johns Creek 6331909, Georgia 4197000 30024

Georgia Clinical Research
Lawrenceville 4205196, Georgia 4197000 30044

St Lukes Idaho Cardiology Associates
Meridian 5600685, Idaho 5596512 83642

Solaris Clinical Research
Meridian 5600685, Idaho 5596512 83646

Christie Clinic
Champaign 4887158, Illinois 4896861 61822

Alliance for Multispecialty Research, LLC - Park Ridge
Park Ridge 4905367, Illinois 4896861 66068

MediSphere Medical Research Center LLC
Evansville 4257227, Indiana 4921868 47714

Parkview Research Center
Fort Wayne 4920423, Indiana 4921868 46845

Franciscan Health Indianapolis
Indianapolis 4259418, Indiana 4921868 46237

Ascension Saint Vincent Heart Center
Indianapolis 4259418, Indiana 4921868 46290

Cardiovascular Research of Northwest Indiana LLC
Munster 4924014, Indiana 4921868 46321

Reid Physician Associates
Richmond 4263681, Indiana 4921868 47374

MercyOne Iowa Heart Center
West Des Moines 4881346, Iowa 4862182 50266

Hutchinson Clinic PA
Hutchinson 4273299, Kansas 4273857 67502

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160

Midwest Heart and Vascular Specialists
Overland Park 4276873, Kansas 4273857 66211

Graves Gilbert Clinic
Bowling Green 4285268, Kentucky 6254925 42101

The Research Group of Lexington LLC
Lexington 4297983, Kentucky 6254925 40503

Heart Clinic of Hammond
Covington 4321005, Louisiana 4331987 70433

Ima Clinical Research
Monroe 4333669, Louisiana 4331987 71201

Louisiana Heart Center
Slidell 4341727, Louisiana 4331987 70458

Monroe Research LLC
West Monroe 4345850, Louisiana 4331987 71291

Ascension Saint Agnes Heart Care
Baltimore 4347778, Maryland 4361885 21229

Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287

Metropolitan Cardiovascular Consultants LLC
Beltsville 4348353, Maryland 4361885 20705

Suburban Hospital
Bethesda 4348599, Maryland 4361885 20814

Flourish Research
Bowie 4349159, Maryland 4361885 20715

Johns Hopkins University
Columbia 4352053, Maryland 4361885 21044

Centennial Medical Group
Columbia 4352053, Maryland 4361885 21045

Medstar Franklin Square Medical Center
Hyattsville 4358821, Maryland 4361885 20782

Capitol Cardiology Associates
Lanham 4360321, Maryland 4361885 20706

Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 02115

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202

MyMichigan Medical Center Midland - Clinical Research Department
Midland 5001929, Michigan 5001836 48670

Advanced Cardiology Associates
Rochester Hills 5007402, Michigan 5001836 48307

Revival Research Institute
Southfield 5010636, Michigan 5001836 48034

Health East Cancer Care
Maplewood 5036588, Minnesota 5037779 55109

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Methodist Hospital
Saint Louis Park 5045021, Minnesota 5037779 55426

Jackson Heart Clinic
Jackson 4431410, Mississippi 4436296 39216

Cardiology Associates Research LLC
Tupelo 4448903, Mississippi 4436296 38801

Sisters of Saint Mary Health Heart and Vascular Care
Bridgeton 4378391, Missouri 4398678 63044

Washington University
St Louis 4407066, Missouri 4398678 63110

Bryan Heart
Lincoln 5072006, Nebraska 5073708 68506

Alliance Clinical Research
Las Vegas 5506956, Nevada 5509151 89109

Excel Clinical Research
Las Vegas 5506956, Nevada 5509151 89109

American Institute of Medical Research
Las Vegas 5506956, Nevada 5509151 89123

Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151 89030

Renown Institute for Heart and Vascular Health
Reno 5511077, Nevada 5509151 89502

Advanced Heart and Vascular Institute of Hunterdon
Flemington 5098124, New Jersey 5101760 08822

Clinical Reseach Philadelphia Pennington
Hamilton 5098765, New Jersey 5101760 08690

Med Clinical Research Partners - Irvington
Irvington 5099724, New Jersey 5101760 07111

New Jersey Medcare / New Jersey Heart
Linden 5100506, New Jersey 5101760 07036

Saint Michaels Medical Center
Newark 5101798, New Jersey 5101760 07102

Circuit Clinical / Optum Medical Care of New Jersey
Secaucus 5104504, New Jersey 5101760 07094

The Heart House - Washington Township
Sewell 4504048, New Jersey 5101760 08080

CardioMetabolic Collaborative Clinic
Somerset 5104755, New Jersey 5101760 08873

Ima Clinical Research - Warren
Warren Township 8299577, New Jersey 5101760 07059

Albany Medical College
Albany 5106834, New York 5128638 12203

Basil Clinical
Inwood 5122280, New York 5128638 11096

Rasai Research
Jackson Heights 5122477, New York 5128638 11372

Crystal Run Healthcare
Monroe 5127302, New York 5128638 10950

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029

Ima Clinical Research Manhattan
New York 5128581, New York 5128638 10036

Niagara Falls Memorial Medical Center
Niagara Falls 5128723, New York 5128638 14304

Circuit Clinical Orchard Park Family Practice
Orchard Park 5129951, New York 5128638 14127

Saratoga Clinical Research, LLC
Saratoga Springs 5136334, New York 5128638 12866

Moses H Cone Memorial Hospital
Greensboro 4469146, North Carolina 4482348 27401

Medication Management LLC
Greensboro 4469146, North Carolina 4482348 27405

Triad Clinical Trials, LLC
Greensboro 4469146, North Carolina 4482348 27410

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112

Piedmont Healthcare
Statesville 4493316, North Carolina 4482348 28625

Accellacare Research of Wilmington
Wilmington 4499379, North Carolina 4482348 28401

Aultman Cardiology Clinical Trials
Canton 5149222, Ohio 5165418 44710

The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219

Velocity Clinical Research - Cincinnati
Cincinnati 4508722, Ohio 5165418 45219

Nexgen Research
Lima 5160783, Ohio 5165418 45801

K and R Research
Marion 5161902, Ohio 5165418 43302

Alliance for Multispecialty Research
Norman 4543762, Oklahoma 4544379 73069

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

Pottstown Medical Specialists Inc
Pottstown 5207069, Pennsylvania 6254927 19464

Pharmacorp Clinical Trials Inc
Charleston 4574324, South Carolina 4597040 29412

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

Prisma Health Carolina Cardiology - Greenville
Gantt 4579484, South Carolina 4597040 29605

Walker Family Care
Little River 4585421, South Carolina 4597040 29566

Accellacare Charleston
Mt. Pleasant 4588165, South Carolina 4597040 29464

Tribe Clinical Research - Spartanburg
Spartanburg 4597200, South Carolina 4597040 29301

Monument Health Clinical Research
Rapid City 5768233, South Dakota 5769223 57701

Erlanger Health, Inc.
Chattanooga 4612862, Tennessee 4662168 37403

Apex Research Foundation, LLC
Jackson 4632595, Tennessee 4662168 38301

Alliance for Multispecialty Research Knoxville
Knoxville 4634946, Tennessee 4662168 37909

Ascension Saint Thomas
Nashville 4644585, Tennessee 4662168 37205

Parkway Cardiology Associates
Oak Ridge 4646571, Tennessee 4662168 37830

Tennessee Center for Clinical Trials
Tullahoma 4663494, Tennessee 4662168 37388

PharmaTex Research, LLC
Amarillo 5516233, Texas 4736286 79106

Texas Diabetes and Endocrinology
Austin 4671654, Texas 4736286 78731

Ima Clinical Research
Austin 4671654, Texas 4736286 78745

Pioneer Medical Associates
Carrollton 4679195, Texas 4736286 75007

Baylor Scott and White Heart and Vascular Hospital-Dallas
Dallas 4684888, Texas 4736286 75226

Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230

Cedar Health Research, LLC
Dallas 4684888, Texas 4736286 75251

Cedar Health Research, LLC
Euless 4689550, Texas 4736286 76040

East Texas Cardiology PA
Houston 4699066, Texas 4736286 77002

Baylor College of Medicine
Houston 4699066, Texas 4736286 77030

Cardiovascular Specialists of Willowbrook
Houston 4699066, Texas 4736286 77070

Vital Heart and Vein
Humble 4699442, Texas 4736286 77338

Tcr Institute Llc
Kingwood 7534469, Texas 4736286 77339

Epic Clinical Research
Lewisville 4706057, Texas 4736286 75057

Texas Tech University Health Sciences Center
Lubbock 5525577, Texas 4736286 79430

North Dallas Research Associates
McKinney 4710178, Texas 4736286 75069

Texas Institute of Cardiology
McKinney 4710178, Texas 4736286 75071

Southern Endocrinology Associates PA
Mesquite 4710826, Texas 4736286 75149

Orion Medical
Pasadena 4717782, Texas 4736286 77505

Valley Institute of Research Plano
Plano 4719457, Texas 4736286 75024

Ima Clinical Research San Antonio
San Antonio 4726206, Texas 4736286 78229

St Davids Heart & Vascular PLLC dba Austin Heart
San Marcos 4726491, Texas 4736286 78666

Revival Research Institute
Sherman 4728328, Texas 4736286 75092

Tyler Cardiovascular Consultants
Tyler 4738214, Texas 4736286 75701

Alpine Research Organization
Layton 5777107, Utah 5549030 84041

Inova Cardiology - Fairfax
Fairfax 4758023, Virginia 6254928 22031

Carient Heart and Vascular
Manassas 4771401, Virginia 6254928 20109

Tidewater Physicians Multispecialty Group Clinical Research
Newport News 4776024, Virginia 6254928 23606

Alliance for Multispecialty Research Norfolk
Norfolk 4776222, Virginia 6254928 23502

Centricity Research
Suffolk 4788158, Virginia 6254928 23435

Selma Medical Associates
Winchester 4794120, Virginia 6254928 22601

Winchester Medical Center
Winchester 4794120, Virginia 6254928 22601

Rainier Clinical Research Center
Renton 5808189, Washington 5815135 98057

More Details

Status: Recruiting
Sponsor: Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com