The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (\<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (\>=) 6
Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
Willing and able to adhere to the lifestyle restrictions specified in this protocol

Criterios de exclusión

Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (\>) 1 year prior with adequate treatment
The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial \[TOAST\] Other Determined Etiology), based on local standard-of-care investigations
Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
Known allergies, hypersensitivity, or intolerance to milvexian or its excipients

Ubicaciones

Fundacion Favaloro

Buenos Aires, Argentina

RECRUITING

Hospital Aleman

Buenos Aires, Argentina

COMPLETED

Sanatorio Finochietto

Buenos Aires, Argentina

COMPLETED

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Sanatorio Los Arcos

Buenos Aires, Argentina

RECRUITING

Sanatorio Guemes

CABA, Argentina

RECRUITING

Sanatorio Mater Dei

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Hospital Gral Agudos Ignacio Pirovano

Ciudad Autonoma Buenos Aires, Argentina

SUSPENDED

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, Argentina

COMPLETED

Hospital Municipal Dr Raul Alfredo Caccavo

Coronel Suárez, Argentina

RECRUITING

Clinica Privada Velez Sarsfield

Córdoba, Argentina

RECRUITING

Clínica Colombo

Córdoba, Argentina

RECRUITING

Hospital San Roque

Córdoba, Argentina

RECRUITING

Clínica Chutro

Córdoba, Argentina

COMPLETED

Sanatorio Allende

Córdoba, Argentina

RECRUITING

Sanatorio de la Canada

Córdoba, Argentina

RECRUITING

Hospital Cordoba

Córdoba, Argentina

RECRUITING

Hospital General de Agudos Dr. J. M. Ramos Mejia

Federal, Argentina

RECRUITING

Sanatorio Parque

Rosario, Argentina

COMPLETED

Hospital Interzonal General de Agudos Eva Perón

San Martín, Argentina

RECRUITING

Clinica Mayo de UMCB

San Miguel de Tucumán, Argentina

COMPLETED

Estudios Clinicos de los Arroyos

San Nicolás, Argentina

RECRUITING

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Milvexian

Placebo

Ubicaciones

Fundacion Favaloro

Hospital Aleman

Sanatorio Finochietto

Hospital Britanico de Buenos Aires

Sanatorio Los Arcos

Sanatorio Guemes

Sanatorio Mater Dei

Hospital Gral Agudos Ignacio Pirovano

Clinica Adventista Belgrano

Hospital Municipal Dr Raul Alfredo Caccavo

Clinica Privada Velez Sarsfield

Clínica Colombo

Hospital San Roque

Clínica Chutro

Sanatorio Allende

Sanatorio de la Canada

Hospital Cordoba

Hospital General de Agudos Dr. J. M. Ramos Mejia

Sanatorio Parque

Hospital Interzonal General de Agudos Eva Perón

Clinica Mayo de UMCB

Estudios Clinicos de los Arroyos

Patrocinadores

Contactos

Study Contact