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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Ubicaciones

Hospital Espanol De Bahia Blanca

Bahía Blanca, Argentina

Hospital Italiano Regional Del Sur

Bahía Blanca, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Sanatorio Finochietto

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

Sanatorio Guemes

CABA, Argentina

Centro Medico Dra. Laura Maffei - Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, Argentina

Instituto Cardiovascular de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Fundacion Favaloro

Ciudad Autonoma Buenos Aires, Argentina

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, Argentina

Clinica Coronel Suarez

Coronel Suárez, Argentina

Clínica Chutro

Córdoba, Argentina

Hospital San Roque

Córdoba, Argentina

Sanatorio Duarte Quiroz

Córdoba, Argentina

Clinica Romagosa

Córdoba, Argentina

Clinica Privada del Prado

Córdoba, Argentina

Sanatorio Allende

Córdoba, Argentina

Sanatorio de la Canada

Córdoba, Argentina

Instituto Privado De Especialidades Medicas S.A. Fundacion J Robert Cade

Córdoba, Argentina

Hospital Cordoba

Córdoba, Argentina

Centro Medico Luquez

Córdoba, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Sanatorio Modelo de Quilmes

Quilmes, Argentina

Instituto Cardiovascular de Rosario

Rosario, Argentina

Sanatorio Parque

Rosario, Argentina

Hospital Italiano Garibaldi

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Centro de Investigaciones Clinicas Salta

Salta, Argentina

Centro Cardiovascular Salta

Salta, Argentina

Hospital El Cruce

San Juan Bautista, Argentina

Corporacion Medica de Gral. San Martin S.A.

San Martín, Argentina

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Argentina

Estudios Clinicos de los Arroyos

San Nicolás, Argentina

Sanatorio Mayo SA

Santa Fe, Argentina

Hospital José María Cullen

Santa Fe, Argentina

Sanatorio Medico de Diagnostico y Tratamiento

Santa Fe, Argentina

Sanatorio San Martin

Venado Tuerto, Argentina

Clinica Privada Fusavim SRL

Villa María, Argentina

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Milvexian

Placebo

Ubicaciones

Hospital Espanol De Bahia Blanca

Hospital Italiano Regional Del Sur

Hospital Italiano de Buenos Aires

Sanatorio Finochietto

Hospital Britanico de Buenos Aires

Sanatorio Guemes

Centro Medico Dra. Laura Maffei - Investigacion Clinica Aplicada

Instituto Cardiovascular de Buenos Aires

Fundacion Favaloro

Clinica Adventista Belgrano

Clinica Coronel Suarez

Clínica Chutro

Hospital San Roque

Sanatorio Duarte Quiroz

Clinica Romagosa

Clinica Privada del Prado

Sanatorio Allende

Sanatorio de la Canada

Instituto Privado De Especialidades Medicas S.A. Fundacion J Robert Cade

Hospital Cordoba

Centro Medico Luquez

Hospital Privado Centro Medico de Cordoba

Hospital Italiano de La Plata

Centro de Investigaciones Medicas Mar Del Plata

Sanatorio Modelo de Quilmes

Instituto Cardiovascular de Rosario

Sanatorio Parque

Hospital Italiano Garibaldi

Hospital Provincial del Centenario

Centro de Investigaciones Clinicas Salta

Centro Cardiovascular Salta

Hospital El Cruce

Corporacion Medica de Gral. San Martin S.A.

Investigaciones Clinicas Tucuman

Estudios Clinicos de los Arroyos

Sanatorio Mayo SA

Hospital José María Cullen

Sanatorio Medico de Diagnostico y Tratamiento

Sanatorio San Martin

Clinica Privada Fusavim SRL

Patrocinadores