Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
NCT ID: NCT04270760
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
281 participants
INTERVENTIONAL
2020-07-28
2022-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 Olpasiran Dose 1
Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Arm 2 Olpasiran Dose 2
Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Arm 3 Olpasiran Dose 3
Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Arm 4 Olpasiran Dose 4
Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Arm 5 Placebo Dose 5
Placebo
Dose 5
Interventions
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Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Placebo
Dose 5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Lipoprotein (a) \> 150 nmol/L
* Evidence of atherosclerotic cardiovascular disease
Exclusion Criteria
* History or clinical evidence of hepatic dysfunction
* Malignancy within the last 5 years
* Currently receiving, or less than 3 months at Day 1 since receiving \> 200 mg/day Niacin
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins
Baltimore, Maryland, United States
New York University
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Crossroads Clinical Research Inc
Mooresville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Protenium Clinical Research
Hurst, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Core Research Group Pty Ltd
Milton, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
Dr Heart Pty Ltd
Woolloongabba, , Australia
LMC Clinical Research Incorporated
Brampton, Ontario, Canada
LMC Clinical Research Incorporated Thornhill
Concord, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Research Institute of McGill University Health Center - Glen Site
Montreal, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Incorporated
Québec, Quebec, Canada
Aarhus Universitetshospital
Aarhus N, , Denmark
Herlev Gentofte Hospital
Herlev, , Denmark
Regionshospitalet Viborg
Viborg, , Denmark
Thjonustumidstod Rannsoknaverkefna
Kopavogur, , Iceland
Asahi General Hospital
Asahi-shi, Chiba, Japan
The Jikei University Kashiwa Hospital
Kashiwa-shi, Chiba, Japan
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
Academisch Medisch Centrum
Amsterdam, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Haga Ziekenhuis
The Hague, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
VieCuri Medisch Centrum
Venlo, , Netherlands
Countries
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References
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O'Donoghue ML, G Lopez JA, Knusel B, Gencer B, Wang H, Wu Y, Kassahun H, Sabatine MS. Study design and rationale for the Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study (OCEAN(a)-DOSE). Am Heart J. 2022 Sep;251:61-69. doi: 10.1016/j.ahj.2022.05.004. Epub 2022 May 16.
O'Donoghue ML, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Ran X, Murphy SA, Wang H, Wu Y, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease. N Engl J Med. 2022 Nov 17;387(20):1855-1864. doi: 10.1056/NEJMoa2211023. Epub 2022 Nov 6.
O'Donoghue ML, Rosenson RS, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Murphy SA, Wang H, Wu Y, Shah T, Wang J, Wilmanski T, Sohn W, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. The Off-Treatment Effects of Olpasiran on Lipoprotein(a) Lowering: OCEAN(a)-DOSE Extension Period Results. J Am Coll Cardiol. 2024 Aug 27;84(9):790-797. doi: 10.1016/j.jacc.2024.05.058.
Kaur G, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Park JG, Wang H, Wu Y, Kassahun H, Sabatine MS, O'Donoghue ML. Olpasiran lowering of lipoprotein(a) according to baseline levels: insights from the OCEAN(a)-DOSE study. Eur Heart J. 2025 Mar 24;46(12):1162-1164. doi: 10.1093/eurheartj/ehae781. No abstract available.
Rosenson RS, Lopez JAG, Gaudet D, Baum SJ, Stout E, Lepor NE, Park JG, Murphy SA, Knusel B, Wang J, Wilmanski T, Wang H, Wu Y, Kassahun H, Sabatine MS, O'Donoghue ML; OCEAN(a)-DOSE Trial Investigators. Olpasiran, Oxidized Phospholipids, and Systemic Inflammatory Biomarkers: Results From the OCEAN(a)-DOSE Trial. JAMA Cardiol. 2025 May 1;10(5):482-486. doi: 10.1001/jamacardio.2024.5433.
Karp 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2019-003688-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20180109
Identifier Type: -
Identifier Source: org_study_id
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