Informations générales (source: ClinicalTrials.gov)

NCT05686070 Active, sans recrutement
A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA (OCEANIC-STROKE)
Interventional
  • Infarctus cérébral
  • Accident ischémique transitoire
  • Ischémie
  • Accident vasculaire cérébral
Phase 3
janvier 2023
octobre 2025
21 mai 2025
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
GHU PARIS PSY ET NEUROSCIENCES Michaël OBADIA En recrutement IDF 12/06/2024 04:28:25  Contacter
HOPITAL FOCH David Weisenburger-lile Active, sans recrutement 15/05/2025 05:26:41  Contacter
HOPITAL FONDATION A. DE ROTHSCHILD Michaël OBADIA En recrutement IDF 17/01/2025 14:54:35  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 Bicêtre Contact (sur clinicalTrials)
AP-HP - Hôpital Bichat Contact (sur clinicalTrials)
AP-HP - Hôpital La Pitié-Salpêtrière Contact (sur clinicalTrials)
AP-HP - Hôpital Lariboisiere-Fernand Widal Contact (sur clinicalTrials)
AP-HP - Hôpital Raymond Poincaré 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
AP-HM - Hopital de la Timone - Service de Neurologie - 13005 - Marseille - Bouches-du-Rhône - France Contact (sur clinicalTrials)
APHP - Hopital Fondation Adolphe De Rothschild - Service de Neurologie - 75019 - Paris - France Contact (sur clinicalTrials)
Centre Hospitalier - Le Mans _ Service de Neurologie - 72037 Cedex 09 - Le Mans - France Contact (sur clinicalTrials)
Centre Hospitalier Boulogne sur Mer - Neurologie - 62321 - Boulogne-sur-mer - France Contact (sur clinicalTrials)
CH Sud Francilien, Neurologie - 91100 - Corbeil-essonnes - France Contact (sur clinicalTrials)
CHRU Besancon - Hopital Jean Minjoz - Service neurologie - 25000 - Besancon - France Contact (sur clinicalTrials)
CHRU de Tours - Hôpital Bretonneau - Service de neurologie - 37044 - TOURS cedex 9 - France Contact (sur clinicalTrials)
CHRU Nancy - Hopital central - Service de neurologie - 54000 - Nancy - France Contact (sur clinicalTrials)
CHU de Brest - Hopital La Cavale Blanche - 29609 - Brest Cedex - France Contact (sur clinicalTrials)
CHU de Nantes - Hopital Laennec - Unite neurovasculaire - 44800 - Saint Herblain - France Contact (sur clinicalTrials)
CHU de Nice - Hopital Pasteur - Unite Neuro Vasculaire - 06000 - Nice - France Contact (sur clinicalTrials)
CHU de Reims - Hopital de la Maison Blanche - Service de Neurologie - 51092 - Reims - France Contact (sur clinicalTrials)
CHU Dijon - Hopital Francois Mitterand - Service neurologie generale vasculaire et degenerative - 21079 - Dijon - France Contact (sur clinicalTrials)
CHU Rennes - Hopital Pontchaillou - Service de neurologie - 35033 - Rennes Cedex 9 - France Contact (sur clinicalTrials)
CHU Strasbourg - Hopital Hautepierre - 67200 - Strasbourg - France Contact (sur clinicalTrials)
CHU Toulouse - Hopital Pierre Paul Riquet PURPAN - 31059 - Toulouse - France Contact (sur clinicalTrials)
GHICL - Hopital Saint-Philibert - 59160 - Lomme - France Contact (sur clinicalTrials)
HCL - Hopital Louis Pradel - Service de Neurologie - 69477 - Bron - Rhone-Alpes - France Contact (sur clinicalTrials)
Hopital Caremeau _ Service de Neurologie - 30900 - Nimes - France Contact (sur clinicalTrials)
Hopital instruction des Armees Sainte Anne - 83800 - Toulon cedex 09 - France Contact (sur clinicalTrials)
Hopital Pellegrin _ Soins Intensifs Unite Neurovasculaire - 33000 - Bordeaux - France Contact (sur clinicalTrials)
Hopital Salengro _ Service de Neurologie et Pathologie Neurovasculaire - 59037 - Lille - France Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Participants must be ≥ 18 years of age

- Acute non-cardioembolic stroke or high-risk TIA

- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct



- Ischemic stroke ≤ 7 days before the index event

- Index stroke following procedures or strokes due to other rare causes

- History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or
other cardioembolic source of stroke requiring anticoagulation