Informations générales (source: ClinicalTrials.gov)
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 (LIBREXIA-STROK)
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
février 2023
décembre 2026
10 octobre 2024
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Raymond Poincaré | Michaël OBADIA | 16/10/2023 16:35:13 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Michaël OBADIA | 21/06/2024 13:35:04 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | Contact (sur clinicalTrials) | ||||
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier - 85925 - La Roche sur Yon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Annecy Genevois - 74374 - Metz-Tessy - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Chartres - 28018 - Chartres cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier De Perpignan - Hopital Marechal Joffre - 66046 - Perpignan - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier du Pays d'Aix Service de Neurologie - 13616 - Aix-en-Provence cedex 01 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nancy - Hôpital Central - 54035 - Nancy - France | Contact (sur clinicalTrials) | ||||
| CHR Metz Thionville Hopital de Mercy - 57530 - Laquenexy - France | Contact (sur clinicalTrials) | ||||
| CHRU Besancon Hopital Jean Minjoz - 25030 - Besançon Cedex - France | Contact (sur clinicalTrials) | ||||
| CHU Bourg en Bresse - 01012 - Bourg en Bresse cedex - France | Contact (sur clinicalTrials) | ||||
| CHU Clermont-Ferrand - Hopital Gabriel Montpied - 63003 - Clermont Ferrand Cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Brest - Hopital de la Cavale Blanche - 29609 - Brest cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Limoges Hopital Dupuytren - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - Hopital la Miletrie - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen Hopital Charles Nicolle - 76031 - Rouen Cedex - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Pellegrin CHU de Bordeaux - 33076 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Timone - 13385 - Marseille cedex 05 - France | Contact (sur clinicalTrials) | ||||
| Hopital Gui de Chauliac - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hopital Pierre Paul Riquet - Purpan - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Hopital Roger Salengro - CHU Lille - 59037 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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