A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome (LIBREXIA-ACS)
Acute Coronary Syndrome
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility 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)
Sites / Locations
- Advanced Cardiovascular, LLCRecruiting
- Ascension St. Vincent's Health SystemRecruiting
- Mobile Heart Specialists, PCRecruiting
- Mercy Gilbert Medical CenterRecruiting
- Valleywise Health Medical CenterRecruiting
- Arkansas Heart HospitalRecruiting
- Mission Cardiovascular Research InstituteRecruiting
- Radin Cardiovascular Medical GroupRecruiting
- Valley Clinical Trials, Inc.Recruiting
- The Cardiovascular CenterRecruiting
- Sharp HealthCareRecruiting
- Ramin Manshadi, MDRecruiting
- South Denver Cardiology Associates PCRecruiting
- Nuvance Health Medical Practices Cardiology DanburyRecruiting
- Integrative Research AssociatesRecruiting
- Shands Jacksonville Medical Center, Inc.dba UF Health JacksonvilleRecruiting
- Cardiology Partners Clinical Research InstituteRecruiting
- Cardiovascular Center of SarasotaRecruiting
- Grady Memorial HospitalRecruiting
- Atlanta Clinical Research CenterRecruiting
- Northeast Georgia Heart CenterRecruiting
- Kootenai Medical CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Prairie Cardiovascular Consultants, Ltd.Recruiting
- Midwest Cardiovascular Research FoundationRecruiting
- Reid HealthRecruiting
- Cambridge Medical TrialsRecruiting
- Louisiana Heart CenterRecruiting
- Eastern Maine Medical Center Northeast Cardiology AssociatesRecruiting
- Tidal Health Peninsula Regional Inc.Recruiting
- St. Luke's Speciality ClinicRecruiting
- Spectrum Clinical ResearchRecruiting
- Bryan LGH Heart InstituteRecruiting
- Methodist Physicians Clinic Heart ConsultantsRecruiting
- Atlanticare Regional Medical CenterRecruiting
- Cardiac Care & Vascular Medicine, PLLCRecruiting
- Hudson Valley Cardiovascular Practice, PCRecruiting
- UNC School of MedicineRecruiting
- Clinical Trials of America
- Sanford CardiologyRecruiting
- Summa Health SystemRecruiting
- Kettering Medical CenterRecruiting
- The Heart HouseRecruiting
- Ascension Medical Group - St. John Clinic Infectious DiseaseRecruiting
- South Oklahoma Heart ResearchRecruiting
- St John Health System IncRecruiting
- AnMed HealthRecruiting
- St. Francis Physician Services, Inc, DBA Upstate Cardiology ResearchRecruiting
- Carolina Cardiology AssociatesRecruiting
- Monument Health Clinical ResearchRecruiting
- Apex CardiologyRecruiting
- Tennessee OncologyRecruiting
- Amarillo Heart Clinical Research InstituteRecruiting
- PharmaTex ResearchRecruiting
- Med Research, Inc.Recruiting
- Texas Tech University Health Sciences Center-El PasoRecruiting
- East Texas Cardiology, PARecruiting
- Texas Cardiology Research CenterRecruiting
- Ascension Texas CardiovascularRecruiting
- Virginia HeartRecruiting
- Winchester Medical CenterRecruiting
- MultiCare Health SystemRecruiting
- Ballarat Base HospitalRecruiting
- Cardresearch - Cardiologia AssistencialRecruiting
- Sociedade Hospitalar Angelina CaronRecruiting
- C.E.C.-Centro Especializado em Cardiologia Ltda.- Loema Medicina e Bem EstarRecruiting
- Santa Casa de Misericórdia de PelotasRecruiting
- Associacao Hospitalar Moinhos de VentoRecruiting
- Fundacao Universitaria de CardiologiaRecruiting
- Hospital Alemao Oswaldo CruzRecruiting
- Instituto Dante Pazzanese de CardiologiaRecruiting
- Dr. Saul Vizel Cardiac Research OfficeRecruiting
- Kawartha Cardiology Clinical TrialsRecruiting
- Office of Dr. Anthony GlanzRecruiting
- Clinique de Cardiologie de LevisRecruiting
- CardioVasc HRRecruiting
- Kasugai Municipal HospitalRecruiting
- Hyogo Prefectural Amagasaki General Medical CenterRecruiting
- Funabashi Munitiple Medical CenterRecruiting
- Fukui Prefectural HospitalRecruiting
- Fukuoka Wajiro HospitalRecruiting
- Gifu Prefectural General Medical CenterRecruiting
- National Hospital Organization Takasaki General Medical CenterRecruiting
- Public Central Hospital of Matto IshikawaRecruiting
- Fukuoka Tokushukai HospitalRecruiting
- Kimitsu Chuo HospitalRecruiting
- Kokura Memorial HospitalRecruiting
- Chikamori HospitalRecruiting
- National Hospital Organization Kure Medical Center and Chugoku Cancer CenterRecruiting
- Chiba-Nishi General HospitalRecruiting
- Jisenkai Aizawa HospitalRecruiting
- Tokyo Saiseikai Central HospitalRecruiting
- Okayama Rosai HospitalRecruiting
- National Hospital Organization Osaka National HospitalRecruiting
- Osaka City General HospitalRecruiting
- Kosekai Iwatsuki-minami HospitalRecruiting
- Kagawa Prefectural Central HospitalRecruiting
- Ome Municipal General HospitalRecruiting
- Tsukuba Medical Center HospitalRecruiting
- Tokyobay Urayasu Ichikawa Medical CenterRecruiting
- Sarawak General HospitalRecruiting
- Hospital MiriRecruiting
- University of OtagoRecruiting
- Hawkes Bay HospitalRecruiting
- Panorama MediClinicRecruiting
- Tread ResearchRecruiting
- Garda, RARecruiting
- Dr J.M. Engelbrecht Trial SiteRecruiting
- Helderberg Research InstituteRecruiting
- Clinical Projects Research SA (PTY) LTDRecruiting
- Changhua Christian HospitalRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- E-DA HospitalRecruiting
- Far Eastern Memorial HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Cheng Hsin General HospitalRecruiting
- Tri-Service General HospitalRecruiting
- Taipei Municipal Wanfang HospitalRecruiting
- Maharaj Nakorn Chiang Mai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Milvexian
Placebo
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 orally.
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.