Last updated 16 days ago
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
16000 patients around the world
Available in Brazil, Argentina, Chile, Mexico
Janssen Research & Development, LLC
48Research sites
16000Patients around the world
This study is for people with
Acute Coronary Syndrome
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization.Clinical syndrome consistent with spontaneous cardiac ischemia.Diagnosis of acute coronary syndrome (ACS) that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA].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.Age 65 or older.Diabetes mellitus.History of a prior myocardial infarction (MI) other than index ACS event.Multivessel coronary artery disease (CAD).History of coronary artery bypass graft (CABG) surgery prior to index ACS event.History of peripheral artery disease (PAD) or cerebrovascular disease example, carotid atherosclerosis, intracranial artery stenosis.Conservative management that is, no percutaneous intervention [PCI] or CABG after index ACS event.Any one or more of the following high-risk angiographic features.Total stent length of greater than 30 millimeters (mm).Thrombotic target lesion.Bifurcation lesion treated with more than one stent.Calcified target lesion treated with atherectomy.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.
- 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
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Sanatorio San Martin
Recruiting
Hospital Dr. José María Cullen
Recruiting
Sanatorio Parque - Rosario
Recruiting
Centro Cardiovascular Salta (Torzav SRL)
Recruiting
Sociedade Hospitalar Angelina Caron
Recruiting
Instituto De Pesquisa Clinica de Campinas - Ipecc
Recruiting
Pontifícia Universidade Católica do Paraná - PUCPR
Recruiting
ICM - Instituto do Coração de Marília
Recruiting
Instituto Atena de Pesquisa Clínica
Recruiting
StudyLIBREXIA-ACS
SponsorJanssen Research & Development, LLC
Conditions
Acute Coronary Syndrome
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05754957
