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Набира участници Фаза 3 NCT05702034

A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE

Фаза 3 – широко изпитване преди одобрение
Заболявания: Ischemic Stroke; Ischemic Attack, Transient

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
Кой може да участва
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Места на провеждане 43
Argentina (1)
Fundacion Favaloro
Buenos Aires
Австралия (1)
Royal Adelaide Hospital
Adelaide
Белгия (1)
ZNA Middelheim
Antwerp
Бразилия (1)
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte
България (1)
Multiprofile Hospital for Active Treatment Puls
Blagoevgrad
Канада (1)
University of Calgary
Calgary , Alberta
Chile (1)
Hospital Base de Osorno
Osorno
Китай (1)
The People's Hospital of Anyang City
Anyang
Хърватия (1)
Opca bolnica Bjelovar
Bjelovar
Чехия (1)
Fakultni nemocnice Brno
Brno
COMPLETED
Дания (1)
Ålborg Universitetshospital
Aalborg
Estonia (1)
West Tallinn Central Hospital
Tallinn
Финландия (1)
Helsinki University Hospital
HUS
Франция (1)
Centre Hospitalier du Pays d'Aix Service de Neurologie
Aix-en-Provence
COMPLETED
Гърция (1)
Uni General Hospital of Alexandroupolis
Alexandroupoli
Hong Kong (1)
The University of Hong Kong
Hong Kong
Унгария (1)
Péterfy Sándor utcai Kórház
Budapest
Индия (1)
NHL Medical College (SVP Hospital IMSR)
Ahmedabad
Израел (1)
Soroka University Medical Center
Beersheba
Италия (1)
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia
Япония (1)
Funabashi Municipal Medical Center
Chiba
Latvia (1)
Riga East Clinical University Hospital
Riga
Lithuania (1)
Vilnius University Hospital Santariskiu Clinic, Public Institution
Vilnius
Malaysia (1)
Hospital Raja Permaisuri Bainun
Ipoh
Mexico (1)
Hospital Cardiologica Aguascalientes
Aguascalientes
Нидерландия (1)
Amphia Ziekenhuis
Breda
New Zealand (1)
Auckland City Hospital
Auckland
Philippines (1)
Cebu Doctors University Hospital
Cebu
Полша (1)
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok
Румъния (1)
Spitalul Clinic Judetean de Urgenta Arad
Arad
Сърбия (1)
Special Hospital for Cerebrovascular Disease Sveti Sava
Belgrade
Сингапур (1)
National University Hospital
Singapore
Словакия (1)
FNsP F. D. Roosevelta Banska Bystrica
Banská Bystrica
South Africa (1)
Iatros International
Bloemfontein
COMPLETED
Южна Корея (1)
Hallym University Sacred Heart Hospital
Anyang-si
Испания (1)
Hosp Univ A Coruna
A Coruña
Швеция (1)
Sahlgrenska University Hospital
Gothenburg
Taiwan (1)
Changhua Christian Hospital
Changhua
Тайланд (1)
Phramongkutklao Hospital and Medical College
Bangkok
Турция (1)
Ankara University
Ankara
SUSPENDED
Великобритания (1)
Aberdeen Royal Infirmary
Aberdeen
САЩ (1)
Banner Desert Medical Center
Mesa , Arizona
Vietnam (1)
Da Nang General Hospital
Da Nang
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Здрави доброволци
Не
Начална дата
15.02.2023
Крайна дата
09.12.2026
Регистрационен номер
NCT05702034
Източник
anzctr
Запитване за медицински туризъм

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