Atherosclerotic Cardiovascular DiseasePhase 3NCT05581303
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
A Phase 3 study testing Olpasiran in people with Atherosclerotic Cardiovascular Disease, run by Amgen at 492 sites in 24 countries.
Trial summary
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atherosclerotic 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
- 7,297 participants
- Where
- 492 sitesin 24 countries
- Study dates
- 14 Dec 2022to 31 Mar 2028
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to ≤ 85 years
- Lp(a) ≥ 200 nmol/L during screening
- History of ASCVD as evidenced by history of either:
- Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or
- Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.
Who cannot join
- Severe renal dysfunction
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening
- History of hemorrhagic stroke
- History of major bleeding disorder
- Planned cardiac surgery or arterial revascularization
- Severe heart failure
- Current, recent, or planned lipoprotein apheresis
- Previously received ribonucleic acid therapy specifically targeting Lp(a)
Trial locations and contacts
492 sites in 24 countries.
492 sites in 24 countries
United States122 sites
Endeavor Health-Northwest Community Healthcare
Arlington Heights, Illinois, 60005
Asheville Cardiology Associates
Asheville, North Carolina, 28801
Piedmont Healthcare
Atlanta, Georgia, 30309
Morehouse School of Medicine
Atlanta, Georgia, 30310
Texas Diabetes and Endocrinology
Austin, Texas, 78731
University of Maryland Medical Center
Baltimore, Maryland, 21201
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
Johns Hopkins University
Baltimore, Maryland, 21287
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
Metropolitan Cardiovascular Consultants LLC
Beltsville, Maryland, 20705
National Heart Institute
Beverly Hills, California, 90211
Pacific Oaks Medical Group
Beverly Hills, California, 90211
University of Alabama Saint Vincent's Birmingham
Birmingham, Alabama, 35205
Grandview Medical Center Affinity Cardiovascular Specialists, LLC
Birmingham, Alabama, 35243
Brigham and Womens Hospital
Boston, Massachusetts, 02215
Bay Area Cardiology
Brandon, Florida, 33511
Medical University of South Carolina
Charleston, South Carolina, 29425
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
UCHealth Memorial Central
Colorado Springs, Colorado, 80909
Prisma Health Midlands Cardiology
Columbia, South Carolina, 29203
The OhioHealth Research Institute
Columbus, Ohio, 43210
Saint Elizabeth Covington
Covington, Kentucky, 41011
Louisiana Heart Center
Covington, Louisiana, 70433
Northeast Georgia Medical Center Wisteria Building
Cumming, Georgia, 30041
Baylor Scott and White Heart and Vascular Hospital-Dallas
Dallas, Texas, 75226
Southwest Family Medicine Associates
Dallas, Texas, 75247
Cardiology Associates Research LLC
Daytona Beach, Florida, 32117
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
David Turbay, MD
El Paso, Texas, 79905
Endeavor Health Skokie Hospital
Evanston, Illinois, 60201
Inova Heart and Vascular Institute
Fairfax, Virginia, 22031
Virginia Heart - Loudoun
Falls Church, Virginia, 22042
Lillestol Research LLC
Fargo, North Dakota, 58104
Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
Piedmont Research Partners
Fort Mill, South Carolina, 29707
Stern Cardiovascular Foundation Inc
Germantown, Tennessee, 38138
Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27401
Elite Cardiac Research Center LLC
Hialeah, Florida, 33013
Baylor College of Medicine
Houston, Texas, 77030
Huntsville Clinical Research, LLC
Huntsville, Alabama, 35801
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
Westside Center for Clinical Research
Jacksonville, Florida, 32205
University of Florida
Jacksonville, Florida, 32209
East Coast Institute for Research LLC
Jacksonville, Florida, 32216
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Nsc Research
Johns Creek, Georgia, 30024
University of Kansas Medical Center
Kansas City, Kansas, 66160
Kettering Medical Center
Kettering, Ohio, 45429
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
University of California San Diego
La Jolla, California, 92037
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Palm Research Center Inc
Las Vegas, Nevada, 89148
Virginia Heart
Leesburg, Virginia, 20176
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
Bryan Heart
Lincoln, Nebraska, 68506
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Carient Heart and Vascular
Manassas, Virginia, 20109
Northwell Health Physician Partners Cardiology at Manhasset
Manhasset, New York, 11030
Fairview Health Services M Health Fairview St Johns Hospital
Maplewood, Minnesota, 55109
Rama Research LLC
Marion, Ohio, 43302
Texas Institute of Cardiology
McKinney, Texas, 75071
St Lukes Idaho
Meridian, Idaho, 83642
Excel Medical Clinical Trials
Miami, Florida, 33135
Bon Secours Cardiology
Midlothian, Virginia, 23114
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55455
Mobile Heart Specialists PC
Mobile, Alabama, 36608
Clinical Trials of America Inc
Monroe, Louisiana, 71201
Cardiovascular Research of Northwest Indiana LLC
Munster, Indiana, 46321
Advanced Research for Health Improvement, LLC
Naples, Florida, 34102
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, 10016
Northwell Health Lenox Hill Heart and Vascular
New York, New York, 10022
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Saint Michaels Medical Center
Newark, New Jersey, 07102
Capital Area Research LLC
Newport, Pennsylvania, 17074
Tidewater Physicians Multispecialty Group Clinical Research
Newport News, Virginia, 23606
Ocala Cardiovascular Research
Ocala, Florida, 34471
Permian Research Foundation
Odessa, Texas, 79761
University of California Irvine
Orange, California, 92868
AdventHealth Medical Group Cardiology at Orlando
Orlando, Florida, 32803
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Montefiore Medical Center - Bronx
Philadelphia, Pennsylvania, 19141
HonorHealth Research and Innovation Institute
Phoenix, Arizona, 85006
Elite Clinical Studies LLC
Phoenix, Arizona, 85018
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health and Science University
Portland, Oregon, 97239
Pulse Heart Institute
Puyallup, Washington, 98372
Monument Health Clinical Research
Rapid City, South Dakota, 57701
Renown Institute for Heart and Vascular Health
Reno, Nevada, 89502
Reid Physician Associates
Richmond, Indiana, 47374
Northwell Health Physician Partners at Peconic
Riverhead, New York, 11901
Mayo Clinic
Rochester, Minnesota, 55905
Advanced Cardiology Associates
Rochester Hills, Michigan, 48307
Healthy Heart Cardiology
Rochester Hills, Michigan, 48307
East Coast Institute for Research, LLC
Saint Augustine, Florida, 32086
Saint Johns Center for Clinical Research
Saint Augustine, Florida, 32086
TidalHealth Peninsula Regional, Inc
Salisbury, Maryland, 21804
University of California Los Angeles
Santa Monica, California, 90404
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239
Saint Louis Heart and Vascular PC
St Louis, Missouri, 63136
Cardiology Associates of Fairfield County PC
Stamford, Connecticut, 06905
Manshadi Heart Institute
Stockton, California, 95204
Stony Brook University Hospital
Stony Brook, New York, 11794
Overlook Medical Center
Summit, New Jersey, 07901
Med Partners, Inc dba Premiere Medical Center, Inc
Toluca Lake, California, 91602
Northwest Houston Heart Center
Tomball, Texas, 77375
Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
Troy, Michigan, 48098
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388
Cardiology Associates Research LLC
Tupelo, Mississippi, 38801
WMCHealth Heart and Vascular Institute Kingston Division of Cardiology
Valhalla, New York, 10595
MedStar Clinical Research
Washington D.C., District of Columbia, 20010
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50266
Monroe Research LLC
West Monroe, Louisiana, 71291
Winchester Cardiology and Vascular Medicine
Winchester, Virginia, 22601
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
White Plains Hospital Physician Associates - Hudson Valley Cardiovascular Group
Yorktown Heights, New York, 10598
Japan59 sites
Ageo Central General Hospital
Ageo-shi, Saitama, 362-8588
Asahi General Hospital
Asahi-shi, Chiba, 289-2511
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
University of Yamanashi Hospital
Chuo-shi, Yamanashi, 409-3898
Fujisawa City Hospital
Fujisawa-shi, Kanagawa, 251-8550
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Gifu Heart Center
Gifu, Gifu, 500-8384
Medical Corporation Kenshinkai Minamino Cardiovascular Hospital
Hachioji-shi, Tokyo, 192-0918
Hakodate Municipal Hospital
Hakodate-shi, Hokkaido, 041-8680
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji-shi, Hyōgo, 670-8560
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8563
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518
Tokai University Hospital
Isehara-shi, Kanagawa, 259-1193
Rinku General Medical Center
Izumisano, Osaka, 598-8577
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, 890-8760
Tenyoukai Central Clinic
Kagoshima, Kagoshima-ken, 892-0822
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, 920-0293
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Kasugai Municipal Hospital
Kasugai-shi, Aichi-ken, 486-8510
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, 802-8555
Japan Community Health care Organization Kyushu Hospital
Kitakyushu-shi, Fukuoka, 806-8501
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Chikamori Hospital
Kochi, Kochi, 780-8522
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Kawasaki Medical School Hospital
Kurashiki-shi, Okayama-ken, 701-0192
New Tokyo Heart Clinic
Matsudo-shi, Chiba, 271-0077
Shinshu University Hospital
Matsumoto-shi, Nagano, 390-8621
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-2102
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-0066
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, 180-8610
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
Ome Medical Center
Ome-shi, Tokyo, 198-0042
Sakurabashi Watanabe Advanced Healthcare Hospital
Osaka, Osaka, 530-0005
Osaka City General Hospital
Osaka, Osaka, 534-0021
Osaka Keisatsu Hospital
Osaka, Osaka, 543-0042
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
Osaka General Medical Center
Osaka, Osaka, 558-8558
Saga-ken Medical Centre Koseikan
Saga, Saga-ken, 840-8571
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375
Sanai Hospital
Saitama-shi, Saitama, 338-0837
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Sendai Cardiovascular Center
Sendai, Miyagi, 981-3133
Tosei General Hospital
Seto-shi, Aichi-ken, 489-8642
Tokyo Womens Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Tokuyama Central Hospital
Shunan-shi, Yamaguchi, 745-8522
National Hospital Organization Shizuoka Medical Center
Sunto-gun, Shizuoka, 411-8611
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557
Tomakomai City Hospital
Tomakomai-shi, Hokkaido, 053-8567
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192
Seiyu Memorial Hospital
Wakayama, Wakayama, 649-6335
Showa Medical University Fujigaoka Hospital
Yokohama, Kanagawa, 227-8501
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa, 236-0037
Yokohama Sakae Kyosai Hospital Federation of National Public Service Personnel Mutual Association
Yokohama, Kanagawa, 247-8581
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193
Brazil39 sites
jmf Clinica do Coracao ltda
Aracaju, Sergipe, 49055-530
AngioCor Blumenau
Blumenau, Santa Catarina, 89020-430
Assoc Amparo Saude Ensin e Pesquisa
Brasília, Federal District, 71625-175
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
Loema Instituto de Pesquisa Clinica e Consultores Ltda - Clinica Loema
Campinas, São Paulo, 13092-133
Hospital Universitario Maria Aparecida Pedrossian
Campo Grande, Mato Grosso do Sul, 79080-190
Quanta Diagnostico por Imagem
Curitiba, Paraná, 80045-170
Nucleo de Pesquisa Clinica
Curitiba, Paraná, 80730-150
Hospital Universitario Walter Cantidio - Universidade Federal do Ceara
Fortaleza, Ceará, 60430-270
Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas
Fortaleza, Ceará, 60430-350
Hospital das Clinicas da Universidade Federal de Goias
Goiânia, Goiás, 74605-020
icm Instituto do Coração de Marilia
Marília, São Paulo, 17515-000
Instituto Atena de Pesquisa Clínica
Natal, Rio Grande do Norte, 59020-500
Hospital Sao Francisco da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90410-000
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-001
Imv Pesquisa Cardiologica Sociedade Simples Coracentro
Porto Alegre, Rio Grande do Sul, 90840-440
FZ Pesquisa e Servicos em Cardiologia LTDA
Porto Alegre, Rio Grande do Sul, 91350-280
Procape
Recife, Pernambuco, 50100-060
Hospital Agamenon Magalhaes
Recife, Pernambuco, 52051-380
Clinicor Clinica Cardiologica
Ribeirão Preto, São Paulo, 14026-900
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, 14051-140
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, Rio de Janeiro, 20241-180
Fundacao Pro-Coracao
Rio de Janeiro, Rio de Janeiro, 22240-006
Hospital Santa Izabel
Salvador, Estado de Bahia, 40050-410
Hospital Ana Nery
Salvador, Estado de Bahia, 40301-155
Instituto de Ensino e Pesquisa do Hospital da Bahia
Salvador, Estado de Bahia, 41810-011
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Instituto de Pesquisa em Endocrinologia Clinica IPEC
São Paulo, São Paulo, 01223-001
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909
Centro Paulista de Investigacao Clinica Cepic
São Paulo, São Paulo, 04266-010
Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Eurolatino Pesquisas Medicas
Uberlândia, Minas Gerais, 38400-500
Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
Vitória, Espírito Santo, 29055-450
Integral Pesquisa e Ensino
Votuporanga, São Paulo, 15501-405
China39 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Beijing Hospital
Beijing, Beijing Municipality, 100730
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
China Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
Daqing Oilfield general Hospital
Daqing, Heilongjiang, 163000
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510120
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 510515
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 519041
Zhejiang Hospital
Hangzhou, Zhejiang, 310000
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Huizhou Central Peoples Hospital
Huizhou, Guangdong, 516001
Jinan Central Hospital
Jinan, Shandong, 250013
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Nanjing First Hospital
Nanjing, Jiangsu, 210000
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210011
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
The Second Nanning Peoples Hospital
Nanning, Guangxi, 530031
Nanyang Second General Hospital
Nanyang, Henan, 473009
Qingdao Fuwai Cardiovascular Hospital
Qingdao, Shandong, 266011
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Shanghai Yangpu District Central Hospital( Yangpu Hospital Affiliated to Tongji University)
Shanghai, Shanghai Municipality, 200080
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tianjin Peoples Hospital
Tianjin, Tianjin Municipality, 300120
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214023
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, 710068
Xiangtan Central Hospital
Xiangtan, Hunan, 411100
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Germany29 sites
Universitaetsklinikum Aachen
Aachen, 52074
Universitaets-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189
Universitaetsklinikum der Ruhr-Universitaet Bochum
Bad Oeynhausen, 32545
Velocity Clinical Research GmbH
Berlin, 10787
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353
Klinikum Links der Weser
Bremen, 28277
Universitaetsklinikum Koeln
Cologne, 50937
Universitaetsklinikum Dresden
Dresden, 01307
Universitaetsklinikum Essen
Essen, 45147
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60590
ClinPhenomics CVC GmbH
Frankfurt am Main, 60596
Evangelisches Krankenhaus Goettingen-Weende
Göttingen, 37075
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20251
Cardiologicum Hamburg GbR
Hamburg, 22041
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Braun Ambulantes Herzzentrum Kassel
Kassel, 34121
Universitaetsklinikum Leipzig
Leipzig, 04103
Otto von Guericke Universitaet Magdeburg
Magdeburg, 39120
Universitaetsklinikum Mannheim
Mannheim, 68167
Kardiologische Praxis Doktor Jens Taggeselle
Markkleeberg, 04416
Klinikum rechts der Isar der TUM
München, 80636
Universitaetsklinikum Muenster
Münster, 48149
Kardiologische Gemeinschaftspraxis Papenburg
Papenburg, 26871
Sana-Klinikum Remscheid GmbH
Remscheid, 42859
Lipidambulanz der Universitaet Rostock
Rostock, 18057
Klinik am See - Ruedersdorf
Rüdersdorf, 15562
Hegau-Bodensee-Klinikum Singen
Singen, 78224
Forschungszentrum Ruhr
Witten, 58455
Poland24 sites
American Heart of Poland Spolka Akcyjna
Bełchatów, 97-400
American Heart of Poland Spolka Akcyjna Polsko-Amerykanskie Kliniki Serca
Bielsko-Biala, 43-316
American Heart of Poland Spolka Akcyjna
Chrzanów, 32-500
American Heart of Poland Spolka Akcyjna Polsko-Amerykanskie Kliniki Serca
Dąbrowa Górnicza, 41-300
Velocity Nova Sp zoo Velocity Zamosc
Dębica, 39-200
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Niepubliczny Zaklad Opieki Zdrowotnej Medica Jerzy Cygler
Giżycko, 11-500
American Heart of Poland Spolka Akcyjna Polsko-Amerykanskie Kliniki Serca
Kędzierzyn-Koźle, 47-200
Jaroslaw Ciosek Rajtar-Medica Centrum Medyczne
Krakow, 31-514
Wojewodzki Specjalistyczny Szpital im dr Wladyslawa Bieganskiego w Lodzi
Lodz, 91-347
Miedziowe Centrum Zdrowia SA
Lubin, 59-301
Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski
Lublin, 20-011
CenterMed Spzoo Centermed Lublin
Lublin, 20-044
NZOZ Twoja Przychodnia Spzoo Twoja Przychodnia Spzoo
Lublin, 20-857
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo
Poznan, 60-354
Velocity Nova Sp zoo Velocity Pulawy
Puławy, 24-100
American Heart of Poland Spolka Akcyjna Polsko-Amerykanskie Kliniki Serca
Sztum, 82-400
American Heart of Poland Spolka Akcyjna Polsko-Amerykanskie Kliniki Serca
Tychy, 43-100
Futuremeds Spolka z ograniczona odpowiedzialnoscia
Warsaw, 00-215
Szpital Grochowski imienia Doktora medycyny Rafala Masztaka Spzoo
Warsaw, 04-073
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy
Warsaw, 04-628
Futuremeds spolka z ograniczona odpowiedzialnoscia
Wroclaw, 53-673
Slaskie Centrum Chorob Serca w Zabrzu
Zabrze, 41-800
American Heart of Poland Spolka Akcyjna
Zgierz, 95-100
Spain22 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital de Cabueñes
Gijón, Principality of Asturias, 33394
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, 08907
Hospital Universitario de Leon
León, Castille and León, 24071
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28023
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital de Sant Joan Despi Moises Broggi
Sant Joan Despí, Catalonia, 08970
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
Hospital Arnau de Vilanova de Valencia
Valencia, Valencia, 46015
Hospital Alvaro Cunqueiro
Vigo, Galicia, 36312
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009
Australia20 sites
Nightingale Research
Adelaide, SAU, 5000
Advara HeartCare Wesley
Auchenflower, Queensland, 4066
Flinders Medical Centre
Bedford Park, SAU, 5042
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Victorian Heart Hospital
Clayton, Victoria, 3168
Concord Repatriation General Hospital
Concord, New South Wales, 2139
The Cardiologists Proprietary Limited
Epping, Victoria, 3076
Canberra Hospital
Garran, Australian Capital Territory, 2605
Barwon Health Geelong Hospital
Geelong, Victoria, 3220
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
Advara HeartCare Joondalup
Joondalup, WST, 6027
Advara HeartCare Leabrook
Leabrook, SAU, 5068
Liverpool Hospital
Liverpool, New South Wales, 2170
Core Research Group Pty Ltd
Milton, Queensland, 4064
Linear Clinical Research Limited
Nedlands, WST, 6009
Clinitrials - West Perth
Perth, Western Australia, 6000
Momentum Clinical Research - Darlinghurst
Sydney, New South Wales, 2010
Wollongong Hospital
Wollongong, New South Wales, 2500
Dr Heart Pty Ltd
Woolloongabba, Queensland, 4102
France19 sites
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
Besançon, 25030
Hospices Civils de Lyon Groupement Hospitalier Est - Hopital Louis Pradel
Bron, 69677
Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau
Chambray-lès-Tours, 37170
Centre Hospitalier Compiegne-Noyon
Compiègne, 60200
Centre Hospitalier Universitaire de Dijon - Hopital Francois Mitterrand
Dijon, 21079
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59037
Hopital de la Conception
Marseille, 13005
Hopital Saint-Joseph
Marseille, 13285
Centre Hospitalier Universitaire de Montpellier - Hopital Lapeyronie
Montpellier, 34090
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
Nantes, 44800
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice, 06000
Hopital Saint Antoine
Paris, 75012
Hopital Pitie-Salpetriere
Paris, 75013
Hopital Bichat Claude Bernard
Paris, 75877
Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
Reims, 51092
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
Strasbourg, 67000
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, 31059
Polyclinique Vauban
Valenciennes, 59300
Italy18 sites
Ospedali dell Ovest Vicentino
Arzignano, 36071
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, 40138
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
Azienda Ospedaliera Sant Anna e San Sebastiano
Caserta, 81100
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, 88100
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna
Cona FE, 44124
Azienda Ospedaliero Universitaria Careggi
Florence, 50139
IRCCS Centro Cardiologico Monzino
Milan, 20138
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
ASL TO3 Ospedale di Rivoli
Rivoli, 10098
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, 00133
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona
Salerno, 84131
Multimedica
Sesto San Giovanni (MI), 20099
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128
Hungary16 sites
Lausmed Kft
Baja, 6500
Dr Lakatos Ferenc Private Cardiology Practice
Békéscsaba, 5600
Budapesti Szent Ferenc Korhaz
Budapest, 1021
High Tech Medical Kft
Budapest, 1027
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet
Budapest, 1096
Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika
Budapest, 1122
Eszak-Pesti Centrum Korhaz - Honvedkorhaz
Budapest, 1134
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Pharma4 Trial Kft
Gyöngyös, 3200
BKS Research Kft
Hatvan, 3000
Komaromi Selye Janos Korhaz
Komárom, 2921
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526
Vita Verum Medical Bt
Székesfehérvár, 8000
Dr Nagy Laszlo Kardiologiai maganrendeles es SMO
Szentes, 6600
Belvarosi Egeszseghaz Kft
Zalaegerszeg, 8900
Obudai Egeszsegugyi Centrum Kft
Zalaegerszeg, 8900
South Korea13 sites
Dong-A University Hospital
Busan, 49201
Chonnam National University Hospital
Gwangju, 61469
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Korea University Guro Hospital
Seoul, 08308
Ulsan University Hospital
Ulsan, 44033
Yonsei University Wonju Severance Christian Hospital
Wonju-si, Gangwon-do, 26426
Greece12 sites
General Hospital of Athens Evaggelismos
Athens, 10676
Athens Naval Hospital
Athens, 11521
General Hospital of Athens Ippokrateio
Athens, 11527
Laiko General Hospital of Athens
Athens, 11527
Alexandra Hospital
Athens, 11528
Attikon Hospital
Athens, 12462
Konstantopoulio - Agia Olga Hospital of Nea Ionia
Athens, 14233
Hygeia Hospital
Athens, 15123
Metropolitan Hospital
Athens, 18547
University Hospital of Heraklion
Heraklion, 71500
University Hospital of Ioannina
Ioannina, 45500
General Hospital of Thessaloniki Ahepa
Thessaloniki, 54636
Austria11 sites
Landeskrankenhaus Feldkirch
Feldkirch, 6800
Medizinische Universitaet Graz
Graz, 8036
Klinikum Klagenfurt am Woerthersee
Klagenfurt, 9020
Krankenhaus der Barmherzigen Brueder Linz
Linz, 4021
Landeskrankenhaus Salzburg
Salzburg, 5020
Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100
Klinik Landstrasse
Vienna, 1030
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Klinik Hietzing
Vienna, 1130
Klinik Ottakring
Vienna, 1160
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210
Bulgaria10 sites
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad, 2700
Medical Center Medconsult Pleven OOD
Pleven, 5800
Multiprofile Hospital for Active Treatment Heart and Brain EAD
Pleven, 5804
Medical Center Cardiomed 2020 EOOD
Sliven, 8800
Multiprofile Hospital for Active Treatment National Hospital of Cardiology EAD
Sofia, 1309
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD-Third clinical base
Sofia, 1407
Medical Center Kalimat EOOD
Sofia, 1756
Medical Center Medicabilis EOOD
Sofia, 1784
Medical Center Orpheus OOD
Stara Zagora, 6000
Ambulatory for Individual Practice for Specialized Medical Care - Kardio EOOD
Varna, 9020
Taiwan9 sites
Hualien Tzu Chi Hospital
Hualien City, Hualien, 97002
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 80756
Mackay Memorial Hospital Tamsui Branch
New Taipei City, New Taipei, 25160
Chung Shan Medical University Hospital
Taichung, Taichung, 40201
Veterans General Hospital - Taichung
Taichung, Taichung, 40705
National Cheng Kung University Hospital
Tainan, Tainan, 70403
National Taiwan University Hospital
Taipei, Taipei, 10002
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taipei, 111045
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, Taoyuan, 33305
Mexico8 sites
Fundacion Cardiovascular de Aguascalientes AC
Aguascalientes, Aguascalientes, 20230
Hospital Cardiologica Aguascalientes
Aguascalientes, Aguascalientes, 20230
Scientia Investigacion Clinica SC
Chihuahua City, Chihuahua, 31207
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC
Culiacán, Sinaloa, 80230
Virgen Cardiovascular Research SC
Guadalajara, Jalisco, 44670
Procliniq Investigacion Clinica
Mexico City, 14050
Eukarya PharmaSite
Monterrey, Nuevo León, 64718
Consultorio de Medicina Especializada del Sector Privado
Xalapa, Veracruz, 91193
Sweden6 sites
Falu Lasarett
Falun, 791 82
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Helsingborgs Lasarett
Helsingborg, 252 21
Clemenstorgets Hjartmottagning
Lund, 222 21
Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86
Karolinska Universitetssjukhuset Solna
Stockholm, 171 64
Finland5 sites
Helsinki University Central Hospital
Helsinki, 000290
Satucon Oy/Kuopion tyoterveys
Kuopio, 70100
Oulu University Hospital
Oulu, 90029
Tampere University Hospital
Tampere, 33520
Suomen Terveystalo Oy
Turku, 20100
Estonia4 sites
Innomedica
Tallinn, 10117
Center for Clinical and Basic Research Tallinn
Tallinn, 10128
North Estonia Medical Centre Foundation
Tallinn, 13419
Tartu University Hospital
Tartu, 50406
Norway3 sites
Oslo Universitetssykehus HF Aker sykehus
Oslo, 0424
Oslo Universitetssykehus HF, Aker sykehus
Oslo, 0586
Skedsmo Medisinske senter
Skedsmokorset, 2020
Hong Kong2 sites
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Placebo, Olpasiran
- Keywords
- Atherosclerotic Cardiovascular Disease, ASCVD, AMG 890, Olpasiran
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo given by subcutaneous injection once every 12 weeks (Q12W).
OlpasiranDrug
Olpasiran given by subcutaneous injection Q12W.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be administered by subcutaneous injection. Receives: Drug: Placebo |
| Olpasiran | Experimental | Olpasiran will be administered by subcutaneous injection. Receives: Drug: Olpasiran |
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: Approximately 5 years
Secondary outcomes (11)
Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
Measured: Approximately 5 years
Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
Measured: Approximately 5 years
Percent change from baseline to Week 48 in Lipoprotein(a)
Measured: Baseline and Week 48
Time to myocardial infarction
Measured: Approximately 5 years
Time to CHD death or myocardial infarction, whichever occurs first
Measured: Approximately 5 years
Time to urgent coronary revascularization
Measured: Approximately 5 years
Time to coronary revascularization
Measured: Approximately 5 years
Time to CHD death
Measured: Approximately 5 years
Time to cardiovascular death
Measured: Approximately 5 years
Time to death by any cause
Measured: Approximately 5 years
Time to ischemic stroke
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start14 Dec 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic 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
- 7,297 participants (actual)
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
- NCT05581303
- Sponsor's protocol ID
- 20180244
- Other IDs
- 2022-501608-85
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2022
- Last updated
- 27 Oct 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
Publications
Procyk G, Tyrna P, Mlynarczuk-Bialy I, Budzianowski J, Olasinska-Wisniewska A, Kochman J, Gasecka A. Lipoprotein(a) and clinical outcomes after transcatheter aortic valve implantation: a prospective, multicenter cohort study. Pol Arch Intern Med. 2026 Apr 29;136(4):17253. doi: 10.20452/pamw.17253. Epub 2026 Mar 17.
PubMed 41841810Byambaa E, Roshanravan B, Berglund L. Lipoprotein(a) and CKD: Insights into New Therapeutic Opportunities. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1469-1481. doi: 10.2215/CJN.0000000968. Epub 2025 Dec 2.
PubMed 41329869Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
PubMed 39329200Burvill A, Watts GF, Norman R, Ademi Z. Early health technology assessment of gene silencing therapies for lowering lipoprotein(a) in the secondary prevention of coronary heart disease. J Clin Lipidol. 2024 Nov-Dec;18(6):e946-e956. doi: 10.1016/j.jacl.2024.08.012. Epub 2024 Aug 31.
PubMed 39322524Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
PubMed 38682459Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.
PubMed 38415744
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 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 the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
- ClinicalTrials.gov ID
- NCT05581303
- Acronym / sponsor ID
- 20180244
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- Atherosclerotic Cardiovascular Disease, ASCVD, AMG 890, Olpasiran
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,297 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Oct 2022 (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 of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered by subcutaneous injection. |
| Olpasiran | Experimental | Drug: OlpasiranOlpasiran will be administered by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to ≤ 85 years
- Lp(a) ≥ 200 nmol/L during screening
- History of ASCVD as evidenced by history of either:
Key exclusion criteria (8 listed)
- Severe renal dysfunction
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening
- History of hemorrhagic stroke
- History of major bleeding disorder
- Planned cardiac surgery or arterial revascularization
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 |
|---|---|---|
| PlaceboPlacebo given by subcutaneous injection once every 12 weeks (Q12W). | Drug | Placebo |
| OlpasiranOlpasiran given by subcutaneous injection Q12W. | Drug | Olpasiran |
Primary outcome
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first
Time frame: Approximately 5 years
11 secondary outcomes
Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
Time frame: Approximately 5 years
Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
Time frame: Approximately 5 years
Percent change from baseline to Week 48 in Lipoprotein(a)
Time frame: Baseline and Week 48
Time to myocardial infarction
Time frame: Approximately 5 years
Time to CHD death or myocardial infarction, whichever occurs first
Time frame: Approximately 5 years
Time to urgent coronary revascularization
Time frame: Approximately 5 years
Time to coronary revascularization
Time frame: Approximately 5 years
Time to CHD death
Time frame: Approximately 5 years
Time to cardiovascular death
Time frame: Approximately 5 years
Time to death by any cause
Time frame: Approximately 5 years
Time to ischemic stroke
Time frame: Approximately 5 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 27 Oct 2026.
- Derived from this study: PubMed 41841810Procyk G, Tyrna P, Mlynarczuk-Bialy I, Budzianowski J, Olasinska-Wisniewska A, Kochman J, Gasecka A. Lipoprotein(a) and clinical outcomes after transcatheter aortic valve implantation: a prospective, multicenter cohort study. Pol Arch Intern Med. 2026 Apr 29;136(4):17253. doi: 10.20452/pamw.17253. Epub 2026 Mar 17.
- Derived from this study: PubMed 41329869Byambaa E, Roshanravan B, Berglund L. Lipoprotein(a) and CKD: Insights into New Therapeutic Opportunities. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1469-1481. doi: 10.2215/CJN.0000000968. Epub 2025 Dec 2.
- Derived from this study: PubMed 39329200Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
- Derived from this study: PubMed 39322524Burvill A, Watts GF, Norman R, Ademi Z. Early health technology assessment of gene silencing therapies for lowering lipoprotein(a) in the secondary prevention of coronary heart disease. J Clin Lipidol. 2024 Nov-Dec;18(6):e946-e956. doi: 10.1016/j.jacl.2024.08.012. Epub 2024 Aug 31.
- Derived from this study: PubMed 38682459Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
- Derived from this study: PubMed 38415744Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.
- 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. This study is not recruiting at the moment.
MD study director
Amgen
492 sites in 24 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 Atherosclerotic Cardiovascular Disease, run by Amgen at 492 sites in 24 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 492 sites in United States, Japan, Brazil, China, Germany and 19 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: Approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05581303, which also lists 6 linked publications.
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 27 Oct 2026.