A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Acute Coronary SyndromeThe 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).
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* 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
* 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)
* All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening
* 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
Exclusion Criteria:
* MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
* Planned CABG or staged PCI after randomization
* Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines
* Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)
Study Location
Foothills Hospital
Foothills HospitalCalgary, Alberta
Canada
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Saint Boniface General Hospital
Saint Boniface General HospitalWinnipeg, Manitoba
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Kawartha Cardiology Clinical Trials
Kawartha Cardiology Clinical TrialsPeterborough, Ontario
Canada
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Clinique de Cardiologie de Levis
Clinique de Cardiologie de LevisLevis, Quebec
Canada
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CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur d/b/a CISSS de Lanaudiere
CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur d/b/a CISSS de LanaudiereTerrebonne, Quebec
Canada
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Vancouver General Hospital
Vancouver General HospitalVancouver, British Columbia
Canada
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Hamilton Health Sciences Corporation
Hamilton Health Sciences CorporationHamilton, Ontario
Canada
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University of Ottawa Heart Institute
University of Ottawa Heart InstituteOttawa, Ontario
Canada
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Office of Dr. Anthony Glanz
Office of Dr. Anthony GlanzWindsor, Ontario
Canada
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CardioVasc HR
CardioVasc HRSt Jean sur Richelieu, Quebec
Canada
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University of Alberta
University of AlbertaEdmonton, Alberta
Canada
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Dalhousie University
Dalhousie UniversityHalifax, Nova Scotia
Canada
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Southlake Regional Health Centre
Southlake Regional Health CentreNewmarket, Ontario
Canada
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Niagara Health System
Niagara Health SystemSt Catharines, Ontario
Canada
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Centre de Recherche du CHUM
Centre de Recherche du CHUMMontreal, Quebec
Canada
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CIUSSS de la Mauricie-et-du-Centre-du-Quebec
CIUSSS de la Mauricie-et-du-Centre-du-QuebecTrois-Rivières, Quebec
Canada
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Surrey Memorial Hospital
Surrey Memorial HospitalSurrey, British Columbia
Canada
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Dr. Saul Vizel Cardiac Research Office
Dr. Saul Vizel Cardiac Research OfficeCambridge, Ontario
Canada
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Halton Healthcare Services Corporation
Halton Healthcare Services CorporationOakville, Ontario
Canada
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Toronto Sunnybrook Hospital
Toronto Sunnybrook HospitalToronto, Ontario
Canada
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Montreal General Hospital
Montreal General HospitalMontreal, Quebec
Canada
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Royal University Hospital
Royal University HospitalSaskatoon, Saskatchewan
Canada
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- Study Sponsored By
- Janssen Research & Development, LLC
- Participants Required
- More Information
- Study ID:
NCT05754957