Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 5:38 PM
Study NCT ID:
NCT05581303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723009', 'term': 'olpasiran'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7297}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT07079267', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first', 'timeFrame': 'Approximately 4 years'}], 'secondaryOutcomes': [{'measure': 'Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Percent change from baseline to Week 48 in Lipoprotein(a)', 'timeFrame': 'Baseline and Week 48'}, {'measure': 'Time to myocardial infarction', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to CHD death or myocardial infarction, whichever occurs first', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to urgent coronary revascularization', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to coronary revascularization', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to CHD death', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to cardiovascular death', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to death by any cause', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Time to ischemic stroke', 'timeFrame': 'Approximately 4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atherosclerotic Cardiovascular Disease', 'ASCVD', 'AMG 890', 'Olpasiran'], 'conditions': ['Atherosclerotic Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '41329869', 'type': 'DERIVED', 'citation': 'Byambaa E, Roshanravan B, Berglund L. Lipoprotein(a) and CKD: Insights into New Therapeutic Opportunities. Clin J Am Soc Nephrol. 2025 Dec 2. doi: 10.2215/CJN.0000000968. Online ahead of print.'}, {'pmid': '39329200', 'type': 'DERIVED', 'citation': 'Nicholls 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.'}, {'pmid': '38682459', 'type': 'DERIVED', 'citation': 'Dimitriadis 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.'}, {'pmid': '38415744', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to ≤ 85 years\n* Lp(a)≥ 200 nmol/L during screening\n* History of ASCVD as evidenced by history of either:\n\n * Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or\n * Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.\n\nExclusion Criteria:\n\n* Severe renal dysfunction\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \\> 2 x ULN during screening\n* History of hemorrhagic stroke\n* History of major bleeding disorder\n* Planned cardiac surgery or arterial revascularization\n* Severe heart failure\n* Current, recent, or planned lipoprotein apheresis\n* Previously received ribonucleic acid therapy specifically targeting Lp(a)'}, 'identificationModule': {'nctId': 'NCT05581303', 'briefTitle': 'Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '20180244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be administered by subcutaneous injection', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Olpasiran', 'description': 'Olpasiran will be administered by subcutaneous injection', 'interventionNames': ['Drug: Olpasiran']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given by subcutaneous injection once every 12 weeks (Q12W).', 'armGroupLabels': ['Placebo']}, {'name': 'Olpasiran', 'type': 'DRUG', 'description': 'Olpasiran given by subcutaneous injection Q12W.', 'armGroupLabels': ['Olpasiran']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Ascension Saint Vincents Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 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marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}