Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-30 @ 6:26 PM
Study NCT ID:
NCT05754957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Estonia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720754', 'term': 'milvexian'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14194}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)', 'timeFrame': 'Up to 3 years 6 months', 'description': 'Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.'}], 'secondaryOutcomes': [{'measure': 'Time to the First Occurrence of Major Adverse Vascular Event (MAVE)', 'timeFrame': 'Up to 3 years 6 months', 'description': 'Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE).'}, {'measure': 'Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke', 'timeFrame': 'Up to 3 years 6 months', 'description': 'Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported.'}, {'measure': 'Time to Cardiovascular (CV) Death', 'timeFrame': 'Up to 3 years 6 months', 'description': 'Time to CV death will be reported.'}, {'measure': 'Time to All-cause Mortality (ACM)', 'timeFrame': 'Up to 3 years 6 months', 'description': 'Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '39986336', 'type': 'DERIVED', 'citation': 'Gibson CM, Bahit MC, Mehran R, Mehta SR, Lamee RA, Goto S, Weitz JI, Horrow J, Barnathan ES, Harrington RA, Mahaffey KW, Lam CSP, Pieper KS, Johnston SC, Hankey GJ, Plotnikov AN, Li D, Deng H, Steg PG; Librexia ACS Committees and Investigators.. Oral factor xia inhibitor milvexian after a recent acute coronary syndrome: Rationale and design of the phase 3 (Librexia ACS). Am Heart J. 2025 Jul;285:21-28. doi: 10.1016/j.ahj.2025.02.011. Epub 2025 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular \\[CV\\] death, myocardial infarction \\[MI\\], and ischemic stroke).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction \\[STEMI\\], non-STEMI, or unstable angina \\[UA\\]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB \\[CK-MB\\]) above the upper limit of normal as determined by the local laboratory\n* Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention \\[PCI\\] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (\\>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI)\n* All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening\n* A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention\n\nExclusion Criteria:\n\n* MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event\n* Planned CABG or staged PCI after randomization\n* Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines\n* Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)'}, 'identificationModule': {'nctId': 'NCT05754957', 'acronym': 'LIBREXIA-ACS', 'briefTitle': 'A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'CR109271'}, 'secondaryIdInfos': [{'id': '70033093ACS3003', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2022-501418-69-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Milvexian', 'description': 'Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy \\[SAPT\\] or dual antiplatelet therapy \\[DAPT\\]) as determined by the investigator will receive milvexian 25 milligrams (mg), orally, twice daily.', 'interventionNames': ['Drug: Milvexian']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Milvexian', 'type': 'DRUG', 'otherNames': ['JNJ-70033093', 'BMS-986177'], 'description': 'Milvexian will be administered orally.', 'armGroupLabels': ['Milvexian']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be administered orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35010', 'city': 'Alexander 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