Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation (LIBREXIA-AF)
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
avril 2023
avril 2027
10 octobre 2024
The purpose of this study is to evaluate if milvexian is at least as effective as
apixaban for reducing the risk of the composite stroke and non-central nervous system
(CNS) systemic embolism.
Etablissements
| 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 Broca-La Rochefoucauld-La Collégiale | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| CENTRE HOSPITALIER SUD FRANCILIEN | Contact (sur clinicalTrials) | ||||
| CH DE VERSAILLES SITE ANDRE MIGNOT | 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 de Beziers - 34525 - Beziers cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Cote Basque - 64109 - Bayonne Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Pau - 64000 - Pau - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire - de Nice - Hopital Pasteur - 06002 - Nice Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - Hôpital Hôtel Dieu - 49933 - Angers Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| CHU de Brest - Hopital de la Cavale Blanche - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU de la Timone - 13385 - Marseille cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Limoges Hopital Dupuytren - 87000 - Limoges cedex - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon - 21033 - Dijon cedex - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - Hopital la Miletrie - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen Hopital Charles Nicolle - 76031 - Rouen cedex - France | Contact (sur clinicalTrials) | ||||
| Clinique Du Pont De Chaume - 82000 - Montauban - France | Contact (sur clinicalTrials) | ||||
| Clinique Saint-Hilaire - Centre Frédéric Joliot - 78000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel - 69677 - Bron cedex - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Sud - Hôpital Xavier Arnozan - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
| Polyclinique Vauban - 59300 - Valenciennes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Minimum age of 18 years
- Medically stable and appropriate for chronic antithrombotic treatment
- Atrial fibrillation eligible to receive anticoagulation
- Participant must satisfy one or both of the following categories of risk factors (a
or b): a) one or more of the following risk factors: i) age greater than or equal to
75 years, ii) history of any type of stroke including symptomatic stroke of any
kind. b) two or more of the following risk factors: i) age between 65 and 74 years,
ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v)
heart failure
- Minimum age of 18 years
- Medically stable and appropriate for chronic antithrombotic treatment
- Atrial fibrillation eligible to receive anticoagulation
- Participant must satisfy one or both of the following categories of risk factors (a
or b): a) one or more of the following risk factors: i) age greater than or equal to
75 years, ii) history of any type of stroke including symptomatic stroke of any
kind. b) two or more of the following risk factors: i) age between 65 and 74 years,
ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v)
heart failure
- Hemodynamically significant valve disease or those with valve disease that will
potentially require surgical valve replacement during the study
- Any condition other than AF that requires chronic anticoagulation